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The goal of this research study is to understand whether an at-home exercise program started after hospitalization for HFpEF, and continuing for 4 weeks following discharge from the hospital, can preserve or improve physical function.
Heart failure is the leading cause of hospitalization among adults in the US with patients with preserved ejection fraction (HFpEF) comprising half of those admissions. Many patients exhibit chronic fatigue, exercise intolerance and an inability to perform activities of daily living, which is exacerbated by hospitalization. The goal of this research study is to understand whether an at-home exercise program started soon after hospitalization and continuing for 4 weeks following discharge can improve functional recovery in HFpEF patients. Volunteers will be randomly assigned to receive neuromuscular electrical stimulation (NMES) of their quadriceps muscles or not to receive NMES (control group). Volunteers will be evaluated during hospitalization and 4 weeks following discharge. Assessments will include measurements of physical function by 6 minute walk test and the Short Physical Performance Battery, as well as assessment of subjective physical functional capacity and quality of life using the Medical Outcomes Short form 36 and Kansas City Cardiomyopathy questionnaire.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neuromuscular electrical stimulation | Experimental | Neuromuscular electrical stimulation of the quadriceps. 45 minutes, 5 days per week |
|
| Control | No Intervention | No treatment control |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuromuscular electrical stimulation | Device | Bilateral quadriceps muscle stimulation |
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| Measure | Description | Time Frame |
|---|---|---|
| 6 Minute Walk Distance (6MW) | 6 MW was developed to assess cardiopulmonary fitness in patients with lung and cardiac disease, and has been validated in heart failure patients. It assesses the distance that a patient can walk in 6 minutes time around a standard course. | Change from Hospital Discharge (Within 1 day) to 4-weeks post-discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Short Physical Performance Battery | Short Physical Performance Battery is composed of three tasks assessing balance, gait speed, and ability to stand from a chair. Units on a scale for each domain range from of 0-4 for a total score of 0 to 12, with a higher score indicating better physical function. | Change from Hospital Discharge (Within 1 day) to 4-weeks post-discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Vermont Medical Center | Burlington | Vermont | 05405 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Neuromuscular Electrical Stimulation | Neuromuscular electrical stimulation of the quadriceps. 45 minutes, 5 days per week Neuromuscular electrical stimulation: Bilateral quadriceps muscle stimulation |
| FG001 | Control | No treatment control |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Neuromuscular Electrical Stimulation | Neuromuscular electrical stimulation of the quadriceps. 45 minutes, 5 days per week Neuromuscular electrical stimulation: Bilateral quadriceps muscle stimulation |
| BG001 | Control |
| Units | Counts |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 6 Minute Walk Distance (6MW) | 6 MW was developed to assess cardiopulmonary fitness in patients with lung and cardiac disease, and has been validated in heart failure patients. It assesses the distance that a patient can walk in 6 minutes time around a standard course. | Posted | Mean | Full Range | feet | Change from Hospital Discharge (Within 1 day) to 4-weeks post-discharge |
|
Hospital discharge to 4-weeks post discharge
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Neuromuscular Electrical Stimulation | Neuromuscular electrical stimulation of the quadriceps. 45 minutes, 5 days per week Neuromuscular electrical stimulation: Bilateral quadriceps muscle stimulation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Office of Clinical Trials Research | University of Vermont Medical Center | (802) 656-8990 | clinicaltrials@med.uvm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 30, 2023 | Dec 4, 2023 | Prot_SAP_001.pdf |
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| Katz Index of Independence in Activities of Daily Living | The Katz Index of Independence in Activities of Daily Living, commonly referred to as the Katz ADL, is the most appropriate instrument to assess functional status as a measurement of the client's ability to perform activities of daily living independently. Clinicians typically use the tool to detect problems in performing activities of daily living and to plan care accordingly. The Index ranks adequacy of performance in the six functions of bathing, dressing, toileting, transferring, continence, and feeding. Clients are scored yes/no for independence in each of the six functions. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment. | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
| Lawton Instrumental Activities of Daily Living (IADL) Scale | The Lawton Instrumental Activities of Daily Living Scale (IADL) is an appropriate instrument to assess independent living skills. These skills are considered more complex than the basic activities of daily living as measured by the Katz Index of ADLs. The instrument is most useful for identifying how a person is functioning at the present time, and to identify improvement or deterioration over time. There are eight domains of function measured with the Lawton IADL scale. Women are scored on all 8 areas of function; historically, for men, the areas of food preparation, housekeeping, laundering have been excluded. Since men regularly complete food preparation, housekeeping, and laundering tasks, they were scored in all 8 domains as well. Clients are scored according to their highest level of functioning in that category. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women and men. | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
| Medical Outcomes Short Form 36 | The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status. There are 36 questions that reflect eight sub-domains of health included in this questionnaire. Scores for each domain represent weighted sums of the questions in each sub-domain. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. This measure represents the total computed score across all sub-domains. Lower scores represent worse overall health, while higher scores represent better health. | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
| Medical Outcomes Short Form 36 Question 1 | Responses to Q1. In general, would you say your health is: | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
| Medical Outcomes Short Form 36 Question 2 | Responses to Q2. Compared to one year ago, how would you rate your health in general now? | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
| Medical Outcomes Short Form 36 Question 3a | The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Responses to Q3a. Vigorous activities, such as running, lifting heavy objects, participating in strenuous sports. | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
| Medical Outcomes Short Form 36 Question 3b | The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Responses to Q3b. Moderate activities, such as moving a table, pushing a vacuum cleaner, bowling, or playing golf. | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
| Medical Outcomes Short Form 36 Question 3c | The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Responses to Q3c. Lifting or carrying groceries. | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
| Medical Outcomes Short Form 36 Question 3d | The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Responses to Q3d. Climbing several flights ofstairs | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
| Medical Outcomes Short Form 36 Question 3e | The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Responses to Q3e. Climbing one flight of stairs | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
| Medical Outcomes Short Form 36 Question 3f | The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Responses to Q3f. Bending, kneeling, or stooping | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
| Medical Outcomes Short Form 36 Question 3g | The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Responses to Q3g. Walking more than a mile | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
| Medical Outcomes Short Form 36 Question 3h | The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Responses to Q3h. Walking several blocks | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
| Medical Outcomes Short Form 36 Question 3i | The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Responses to Q3i. Walking one block | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
| Medical Outcomes Short Form 36 Question 3j | The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Responses to Q3j. Bathing or dressing yourself | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
| Medical Outcomes Short Form 36 Question 4a | During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of your physical health? Responses to Q4a. Cut down the amount of time you spent on work or other activities | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
| Medical Outcomes Short Form 36 Question 4b | During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of your physical health? Responses to Q4b. Accomplished less than you would like | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
| Medical Outcomes Short Form 36 Question 4c | During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of your physical health? Responses to Q4c. Were limited in the kind of work or other activities | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
| Medical Outcomes Short Form 36 Question 4d | During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of your physical health? Responses to Q4d. Had difficulty performing the work or other activities (for example, it took extra effort) | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
| Medical Outcomes Short Form 36 Question 5a | During the past 4weeks, have you had any of he following problems with your work or other regular daily activities as a result of any emotional problems (such as feeling depressed or anxious)? Responses to Q5a. Cut down the amount of time you spent on work or other activities | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
| Medical Outcomes Short Form 36 Question 5b | During the past 4weeks, have you had any of he following problems with your work or other regular daily activities as a result of any emotional problems (such as feeling depressed or anxious)? Responses to Q5b. Accomplished less than you would like | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
| Medical Outcomes Short Form 36 Question 5c | During the past 4weeks, have you had any of he following problems with your work or other regular daily activities as a result of any emotional problems (such as feeling depressed or anxious)? Responses to Q5c. Didn't do work or other activities as carefully as usual | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
| Medical Outcomes Short Form 36 Question 6 | Responses to Q6. During the past 4weeks, to what extent has your physical health or emotional problems interfered with your normal social activities with family, friends, neighbors or groups? | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
| Medical Outcomes Short Form 36 Question 7 | Responses to Q7. How much bodily pain have you had during the past four weeks? | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
| Medical Outcomes Short Form 36 Question 8 | Responses to Q8. During the past 4weeks, how much did pain interfere with your normal work (including both work outside the home and housework)? | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
| Medical Outcomes Short Form 36 Question 9a | These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9a. Did you feel full of pep? | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
| Medical Outcomes Short Form 36 Question 9b | These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9b. Have you been a very nervous person? | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
| Medical Outcomes Short Form 36 Question 9c | These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9c. Have you felt so down in the dumps that nothing could cheer you up? | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
| Medical Outcomes Short Form 36 Question 9d | These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9d. Have you felt calm and peaceful? | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
| Medical Outcomes Short Form 36 Question 9e | These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9e. Did you have a lot of energy? | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
| Medical Outcomes Short Form 36 Question 9f | These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9f. Have you felt down hearted and blue? | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
| Medical Outcomes Short Form 36 Question 9g | These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9g. Did you feel worn out? | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
| Medical Outcomes Short Form 36 Question 9h | These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9h. Have you been a happy person? | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
| Medical Outcomes Short Form 36 Question 9i | These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9i. Did you feel tired? | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
| Medical Outcomes Short Form 36 Question 9j | These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9j. During the past 4weeks, how much of the time has your physical health or emotional problems interfered with your social activities (like visiting with friends, relatives, etc.)? | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
| Medical Outcomes Short Form 36 Question 10a | How TRUE or FALSE is each of the following statements for you: Responses to Q10a. I seem to get sick a little easier than other people | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
| Medical Outcomes Short Form 36 Question 10b | How TRUE or FALSE is each of the following statements for you: Responses to Q10b. I am as healthy as anybody I know | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
| Medical Outcomes Short Form 36 Question 10c | How TRUE or FALSE is each of the following statements for you: Responses to Q10c. I expect my health to get worse | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
| Medical Outcomes Short Form 36 Question 10d | How TRUE or FALSE is each of the following statements for you: Responses to Q10d. My health is excellent | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
No treatment control
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Short Physical Performance Battery | Short Physical Performance Battery is composed of three tasks assessing balance, gait speed, and ability to stand from a chair. Units on a scale for each domain range from of 0-4 for a total score of 0 to 12, with a higher score indicating better physical function. | Posted | Mean | Full Range | units on a scale | Change from Hospital Discharge (Within 1 day) to 4-weeks post-discharge |
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| Secondary | Katz Index of Independence in Activities of Daily Living | The Katz Index of Independence in Activities of Daily Living, commonly referred to as the Katz ADL, is the most appropriate instrument to assess functional status as a measurement of the client's ability to perform activities of daily living independently. Clinicians typically use the tool to detect problems in performing activities of daily living and to plan care accordingly. The Index ranks adequacy of performance in the six functions of bathing, dressing, toileting, transferring, continence, and feeding. Clients are scored yes/no for independence in each of the six functions. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment. | Posted | Mean | Full Range | units on a scale | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
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| Secondary | Lawton Instrumental Activities of Daily Living (IADL) Scale | The Lawton Instrumental Activities of Daily Living Scale (IADL) is an appropriate instrument to assess independent living skills. These skills are considered more complex than the basic activities of daily living as measured by the Katz Index of ADLs. The instrument is most useful for identifying how a person is functioning at the present time, and to identify improvement or deterioration over time. There are eight domains of function measured with the Lawton IADL scale. Women are scored on all 8 areas of function; historically, for men, the areas of food preparation, housekeeping, laundering have been excluded. Since men regularly complete food preparation, housekeeping, and laundering tasks, they were scored in all 8 domains as well. Clients are scored according to their highest level of functioning in that category. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women and men. | Posted | Mean | Full Range | units on a scale | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
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| Secondary | Medical Outcomes Short Form 36 | The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status. There are 36 questions that reflect eight sub-domains of health included in this questionnaire. Scores for each domain represent weighted sums of the questions in each sub-domain. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. This measure represents the total computed score across all sub-domains. Lower scores represent worse overall health, while higher scores represent better health. | Due to our statistician retiring, we no longer have access to the computer program tied to the statistician. Without this program we are unable to transform responses into a 0-100 scale. An attempt was made to purchase the grading software, but cost was prohibitive, no funding was available to purchase the program. Unfortunately, there are no plans to acquire the license in the future as our institution has placed a hold on purchases due to budget cuts. | Posted | Count of Participants | Participants | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
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| Secondary | Medical Outcomes Short Form 36 Question 1 | Responses to Q1. In general, would you say your health is: | Due to our statistician retiring, we no longer have access to the computer program tied to the statistician. Without this program we are unable to transform responses into a 0-100 scale. An attempt was made to purchase the grading software, but cost was prohibitive, no funding was available to purchase the program. Unfortunately, there are no plans to acquire the license in the future as our institution has placed a hold on purchases due to budget cuts. | Posted | Count of Participants | Participants | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
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| Secondary | Medical Outcomes Short Form 36 Question 2 | Responses to Q2. Compared to one year ago, how would you rate your health in general now? | Due to our statistician retiring, we no longer have access to the computer program tied to the statistician. Without this program we are unable to transform responses into a 0-100 scale. An attempt was made to purchase the grading software, but cost was prohibitive, no funding was available to purchase the program. Unfortunately, there are no plans to acquire the license in the future as our institution has placed a hold on purchases due to budget cuts. | Posted | Count of Participants | Participants | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
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| Secondary | Medical Outcomes Short Form 36 Question 3a | The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Responses to Q3a. Vigorous activities, such as running, lifting heavy objects, participating in strenuous sports. | Due to our statistician retiring, we no longer have access to the computer program tied to the statistician. Without this program we are unable to transform responses into a 0-100 scale. An attempt was made to purchase the grading software, but cost was prohibitive, no funding was available to purchase the program. Unfortunately, there are no plans to acquire the license in the future as our institution has placed a hold on purchases due to budget cuts. | Posted | Count of Participants | Participants | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
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| Secondary | Medical Outcomes Short Form 36 Question 3b | The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Responses to Q3b. Moderate activities, such as moving a table, pushing a vacuum cleaner, bowling, or playing golf. | Due to our statistician retiring, we no longer have access to the computer program tied to the statistician. Without this program we are unable to transform responses into a 0-100 scale. An attempt was made to purchase the grading software, but cost was prohibitive, no funding was available to purchase the program. Unfortunately, there are no plans to acquire the license in the future as our institution has placed a hold on purchases due to budget cuts. | Posted | Count of Participants | Participants | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
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| Secondary | Medical Outcomes Short Form 36 Question 3c | The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Responses to Q3c. Lifting or carrying groceries. | Due to our statistician retiring, we no longer have access to the computer program tied to the statistician. Without this program we are unable to transform responses into a 0-100 scale. An attempt was made to purchase the grading software, but cost was prohibitive, no funding was available to purchase the program. Unfortunately, there are no plans to acquire the license in the future as our institution has placed a hold on purchases due to budget cuts. | Posted | Count of Participants | Participants | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
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| Secondary | Medical Outcomes Short Form 36 Question 3d | The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Responses to Q3d. Climbing several flights ofstairs | Due to our statistician retiring, we no longer have access to the computer program tied to the statistician. Without this program we are unable to transform responses into a 0-100 scale. An attempt was made to purchase the grading software, but cost was prohibitive, no funding was available to purchase the program. Unfortunately, there are no plans to acquire the license in the future as our institution has placed a hold on purchases due to budget cuts. | Posted | Count of Participants | Participants | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
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| Secondary | Medical Outcomes Short Form 36 Question 3e | The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Responses to Q3e. Climbing one flight of stairs | Due to our statistician retiring, we no longer have access to the computer program tied to the statistician. Without this program we are unable to transform responses into a 0-100 scale. An attempt was made to purchase the grading software, but cost was prohibitive, no funding was available to purchase the program. Unfortunately, there are no plans to acquire the license in the future as our institution has placed a hold on purchases due to budget cuts. | Posted | Count of Participants | Participants | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
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| Secondary | Medical Outcomes Short Form 36 Question 3f | The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Responses to Q3f. Bending, kneeling, or stooping | Due to our statistician retiring, we no longer have access to the computer program tied to the statistician. Without this program we are unable to transform responses into a 0-100 scale. An attempt was made to purchase the grading software, but cost was prohibitive, no funding was available to purchase the program. Unfortunately, there are no plans to acquire the license in the future as our institution has placed a hold on purchases due to budget cuts. | Posted | Count of Participants | Participants | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
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| Secondary | Medical Outcomes Short Form 36 Question 3g | The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Responses to Q3g. Walking more than a mile | Due to our statistician retiring, we no longer have access to the computer program tied to the statistician. Without this program we are unable to transform responses into a 0-100 scale. An attempt was made to purchase the grading software, but cost was prohibitive, no funding was available to purchase the program. Unfortunately, there are no plans to acquire the license in the future as our institution has placed a hold on purchases due to budget cuts. | Posted | Count of Participants | Participants | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
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| Secondary | Medical Outcomes Short Form 36 Question 3h | The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Responses to Q3h. Walking several blocks | Due to our statistician retiring, we no longer have access to the computer program tied to the statistician. Without this program we are unable to transform responses into a 0-100 scale. An attempt was made to purchase the grading software, but cost was prohibitive, no funding was available to purchase the program. Unfortunately, there are no plans to acquire the license in the future as our institution has placed a hold on purchases due to budget cuts. | Posted | Count of Participants | Participants | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
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| Secondary | Medical Outcomes Short Form 36 Question 3i | The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Responses to Q3i. Walking one block | Due to our statistician retiring, we no longer have access to the computer program tied to the statistician. Without this program we are unable to transform responses into a 0-100 scale. An attempt was made to purchase the grading software, but cost was prohibitive, no funding was available to purchase the program. Unfortunately, there are no plans to acquire the license in the future as our institution has placed a hold on purchases due to budget cuts. | Posted | Count of Participants | Participants | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
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| Secondary | Medical Outcomes Short Form 36 Question 3j | The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Responses to Q3j. Bathing or dressing yourself | Due to our statistician retiring, we no longer have access to the computer program tied to the statistician. Without this program we are unable to transform responses into a 0-100 scale. An attempt was made to purchase the grading software, but cost was prohibitive, no funding was available to purchase the program. Unfortunately, there are no plans to acquire the license in the future as our institution has placed a hold on purchases due to budget cuts. | Posted | Count of Participants | Participants | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
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| Secondary | Medical Outcomes Short Form 36 Question 4a | During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of your physical health? Responses to Q4a. Cut down the amount of time you spent on work or other activities | Due to our statistician retiring, we no longer have access to the computer program tied to the statistician. Without this program we are unable to transform responses into a 0-100 scale. An attempt was made to purchase the grading software, but cost was prohibitive, no funding was available to purchase the program. Unfortunately, there are no plans to acquire the license in the future as our institution has placed a hold on purchases due to budget cuts. | Posted | Count of Participants | Participants | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
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| Secondary | Medical Outcomes Short Form 36 Question 4b | During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of your physical health? Responses to Q4b. Accomplished less than you would like | Due to our statistician retiring, we no longer have access to the computer program tied to the statistician. Without this program we are unable to transform responses into a 0-100 scale. An attempt was made to purchase the grading software, but cost was prohibitive, no funding was available to purchase the program. Unfortunately, there are no plans to acquire the license in the future as our institution has placed a hold on purchases due to budget cuts. | Posted | Count of Participants | Participants | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
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| Secondary | Medical Outcomes Short Form 36 Question 4c | During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of your physical health? Responses to Q4c. Were limited in the kind of work or other activities | Due to our statistician retiring, we no longer have access to the computer program tied to the statistician. Without this program we are unable to transform responses into a 0-100 scale. An attempt was made to purchase the grading software, but cost was prohibitive, no funding was available to purchase the program. Unfortunately, there are no plans to acquire the license in the future as our institution has placed a hold on purchases due to budget cuts. | Posted | Count of Participants | Participants | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
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| Secondary | Medical Outcomes Short Form 36 Question 4d | During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of your physical health? Responses to Q4d. Had difficulty performing the work or other activities (for example, it took extra effort) | Due to our statistician retiring, we no longer have access to the computer program tied to the statistician. Without this program we are unable to transform responses into a 0-100 scale. An attempt was made to purchase the grading software, but cost was prohibitive, no funding was available to purchase the program. Unfortunately, there are no plans to acquire the license in the future as our institution has placed a hold on purchases due to budget cuts. | Posted | Count of Participants | Participants | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
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| Secondary | Medical Outcomes Short Form 36 Question 5a | During the past 4weeks, have you had any of he following problems with your work or other regular daily activities as a result of any emotional problems (such as feeling depressed or anxious)? Responses to Q5a. Cut down the amount of time you spent on work or other activities | Due to our statistician retiring, we no longer have access to the computer program tied to the statistician. Without this program we are unable to transform responses into a 0-100 scale. An attempt was made to purchase the grading software, but cost was prohibitive, no funding was available to purchase the program. Unfortunately, there are no plans to acquire the license in the future as our institution has placed a hold on purchases due to budget cuts. | Posted | Count of Participants | Participants | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
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| Secondary | Medical Outcomes Short Form 36 Question 5b | During the past 4weeks, have you had any of he following problems with your work or other regular daily activities as a result of any emotional problems (such as feeling depressed or anxious)? Responses to Q5b. Accomplished less than you would like | Due to our statistician retiring, we no longer have access to the computer program tied to the statistician. Without this program we are unable to transform responses into a 0-100 scale. An attempt was made to purchase the grading software, but cost was prohibitive, no funding was available to purchase the program. Unfortunately, there are no plans to acquire the license in the future as our institution has placed a hold on purchases due to budget cuts. | Posted | Count of Participants | Participants | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
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| Secondary | Medical Outcomes Short Form 36 Question 5c | During the past 4weeks, have you had any of he following problems with your work or other regular daily activities as a result of any emotional problems (such as feeling depressed or anxious)? Responses to Q5c. Didn't do work or other activities as carefully as usual | Due to our statistician retiring, we no longer have access to the computer program tied to the statistician. Without this program we are unable to transform responses into a 0-100 scale. An attempt was made to purchase the grading software, but cost was prohibitive, no funding was available to purchase the program. Unfortunately, there are no plans to acquire the license in the future as our institution has placed a hold on purchases due to budget cuts. | Posted | Count of Participants | Participants | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
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| Secondary | Medical Outcomes Short Form 36 Question 6 | Responses to Q6. During the past 4weeks, to what extent has your physical health or emotional problems interfered with your normal social activities with family, friends, neighbors or groups? | Due to our statistician retiring, we no longer have access to the computer program tied to the statistician. Without this program we are unable to transform responses into a 0-100 scale. An attempt was made to purchase the grading software, but cost was prohibitive, no funding was available to purchase the program. Unfortunately, there are no plans to acquire the license in the future as our institution has placed a hold on purchases due to budget cuts. | Posted | Count of Participants | Participants | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
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| Secondary | Medical Outcomes Short Form 36 Question 7 | Responses to Q7. How much bodily pain have you had during the past four weeks? | Due to our statistician retiring, we no longer have access to the computer program tied to the statistician. Without this program we are unable to transform responses into a 0-100 scale. An attempt was made to purchase the grading software, but cost was prohibitive, no funding was available to purchase the program. Unfortunately, there are no plans to acquire the license in the future as our institution has placed a hold on purchases due to budget cuts. | Posted | Count of Participants | Participants | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
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| Secondary | Medical Outcomes Short Form 36 Question 8 | Responses to Q8. During the past 4weeks, how much did pain interfere with your normal work (including both work outside the home and housework)? | Due to our statistician retiring, we no longer have access to the computer program tied to the statistician. Without this program we are unable to transform responses into a 0-100 scale. An attempt was made to purchase the grading software, but cost was prohibitive, no funding was available to purchase the program. Unfortunately, there are no plans to acquire the license in the future as our institution has placed a hold on purchases due to budget cuts. | Posted | Count of Participants | Participants | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
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| Secondary | Medical Outcomes Short Form 36 Question 9a | These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9a. Did you feel full of pep? | Due to our statistician retiring, we no longer have access to the computer program tied to the statistician. Without this program we are unable to transform responses into a 0-100 scale. An attempt was made to purchase the grading software, but cost was prohibitive, no funding was available to purchase the program. Unfortunately, there are no plans to acquire the license in the future as our institution has placed a hold on purchases due to budget cuts. | Posted | Count of Participants | Participants | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
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| Secondary | Medical Outcomes Short Form 36 Question 9b | These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9b. Have you been a very nervous person? | Due to our statistician retiring, we no longer have access to the computer program tied to the statistician. Without this program we are unable to transform responses into a 0-100 scale. An attempt was made to purchase the grading software, but cost was prohibitive, no funding was available to purchase the program. Unfortunately, there are no plans to acquire the license in the future as our institution has placed a hold on purchases due to budget cuts. | Posted | Count of Participants | Participants | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
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| Secondary | Medical Outcomes Short Form 36 Question 9c | These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9c. Have you felt so down in the dumps that nothing could cheer you up? | Due to our statistician retiring, we no longer have access to the computer program tied to the statistician. Without this program we are unable to transform responses into a 0-100 scale. An attempt was made to purchase the grading software, but cost was prohibitive, no funding was available to purchase the program. Unfortunately, there are no plans to acquire the license in the future as our institution has placed a hold on purchases due to budget cuts. | Posted | Count of Participants | Participants | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
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| Secondary | Medical Outcomes Short Form 36 Question 9d | These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9d. Have you felt calm and peaceful? | Due to our statistician retiring, we no longer have access to the computer program tied to the statistician. Without this program we are unable to transform responses into a 0-100 scale. An attempt was made to purchase the grading software, but cost was prohibitive, no funding was available to purchase the program. Unfortunately, there are no plans to acquire the license in the future as our institution has placed a hold on purchases due to budget cuts. | Posted | Count of Participants | Participants | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
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| Secondary | Medical Outcomes Short Form 36 Question 9e | These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9e. Did you have a lot of energy? | Due to our statistician retiring, we no longer have access to the computer program tied to the statistician. Without this program we are unable to transform responses into a 0-100 scale. An attempt was made to purchase the grading software, but cost was prohibitive, no funding was available to purchase the program. Unfortunately, there are no plans to acquire the license in the future as our institution has placed a hold on purchases due to budget cuts. | Posted | Count of Participants | Participants | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
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| Secondary | Medical Outcomes Short Form 36 Question 9f | These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9f. Have you felt down hearted and blue? | Due to our statistician retiring, we no longer have access to the computer program tied to the statistician. Without this program we are unable to transform responses into a 0-100 scale. An attempt was made to purchase the grading software, but cost was prohibitive, no funding was available to purchase the program. Unfortunately, there are no plans to acquire the license in the future as our institution has placed a hold on purchases due to budget cuts. | Posted | Count of Participants | Participants | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
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| Secondary | Medical Outcomes Short Form 36 Question 9g | These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9g. Did you feel worn out? | Due to our statistician retiring, we no longer have access to the computer program tied to the statistician. Without this program we are unable to transform responses into a 0-100 scale. An attempt was made to purchase the grading software, but cost was prohibitive, no funding was available to purchase the program. Unfortunately, there are no plans to acquire the license in the future as our institution has placed a hold on purchases due to budget cuts. | Posted | Count of Participants | Participants | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
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| Secondary | Medical Outcomes Short Form 36 Question 9h | These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9h. Have you been a happy person? | Due to our statistician retiring, we no longer have access to the computer program tied to the statistician. Without this program we are unable to transform responses into a 0-100 scale. An attempt was made to purchase the grading software, but cost was prohibitive, no funding was available to purchase the program. Unfortunately, there are no plans to acquire the license in the future as our institution has placed a hold on purchases due to budget cuts. | Posted | Count of Participants | Participants | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
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| Secondary | Medical Outcomes Short Form 36 Question 9i | These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9i. Did you feel tired? | Due to our statistician retiring, we no longer have access to the computer program tied to the statistician. Without this program we are unable to transform responses into a 0-100 scale. An attempt was made to purchase the grading software, but cost was prohibitive, no funding was available to purchase the program. Unfortunately, there are no plans to acquire the license in the future as our institution has placed a hold on purchases due to budget cuts. | Posted | Count of Participants | Participants | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
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| Secondary | Medical Outcomes Short Form 36 Question 9j | These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9j. During the past 4weeks, how much of the time has your physical health or emotional problems interfered with your social activities (like visiting with friends, relatives, etc.)? | Due to our statistician retiring, we no longer have access to the computer program tied to the statistician. Without this program we are unable to transform responses into a 0-100 scale. An attempt was made to purchase the grading software, but cost was prohibitive, no funding was available to purchase the program. Unfortunately, there are no plans to acquire the license in the future as our institution has placed a hold on purchases due to budget cuts. | Posted | Count of Participants | Participants | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
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| Secondary | Medical Outcomes Short Form 36 Question 10a | How TRUE or FALSE is each of the following statements for you: Responses to Q10a. I seem to get sick a little easier than other people | Due to our statistician retiring, we no longer have access to the computer program tied to the statistician. Without this program we are unable to transform responses into a 0-100 scale. An attempt was made to purchase the grading software, but cost was prohibitive, no funding was available to purchase the program. Unfortunately, there are no plans to acquire the license in the future as our institution has placed a hold on purchases due to budget cuts. | Posted | Count of Participants | Participants | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
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| Secondary | Medical Outcomes Short Form 36 Question 10b | How TRUE or FALSE is each of the following statements for you: Responses to Q10b. I am as healthy as anybody I know | Due to our statistician retiring, we no longer have access to the computer program tied to the statistician. Without this program we are unable to transform responses into a 0-100 scale. An attempt was made to purchase the grading software, but cost was prohibitive, no funding was available to purchase the program. Unfortunately, there are no plans to acquire the license in the future as our institution has placed a hold on purchases due to budget cuts. | Posted | Count of Participants | Participants | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
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| Secondary | Medical Outcomes Short Form 36 Question 10c | How TRUE or FALSE is each of the following statements for you: Responses to Q10c. I expect my health to get worse | Due to our statistician retiring, we no longer have access to the computer program tied to the statistician. Without this program we are unable to transform responses into a 0-100 scale. An attempt was made to purchase the grading software, but cost was prohibitive, no funding was available to purchase the program. Unfortunately, there are no plans to acquire the license in the future as our institution has placed a hold on purchases due to budget cuts. | Posted | Count of Participants | Participants | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
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| Secondary | Medical Outcomes Short Form 36 Question 10d | How TRUE or FALSE is each of the following statements for you: Responses to Q10d. My health is excellent | Due to our statistician retiring, we no longer have access to the computer program tied to the statistician. Without this program we are unable to transform responses into a 0-100 scale. An attempt was made to purchase the grading software, but cost was prohibitive, no funding was available to purchase the program. Unfortunately, there are no plans to acquire the license in the future as our institution has placed a hold on purchases due to budget cuts. | Posted | Count of Participants | Participants | Hospital discharge (Within 1 day) and 4-weeks post-discharge |
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| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Control | No treatment control | 0 | 4 | 0 | 4 | 0 | 4 |
Not provided
Not provided
Not provided
| Good.............................3 |
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| Fair .............................. 4 |
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| Poor.............................5 |
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| (4 weeks) Q1. In general, would you say your health is: |
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| About the same ..............................................................3 |
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| Somewhat worse now than one year ago ....................... 4 |
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| Much worse now than one year ago ..............................5 |
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| (4 weeks) Q2. Compared to one year ago, how would you rate your health in general now? |
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| No, not limited at all...3 |
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| (4 weeks) Q3a. Vigorous activities |
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| No, not limited at all...3 |
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| (4 weeks) Q3b. Moderate activities |
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| No, not limited at all...3 |
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| (4 weeks) Q3c. Lifting or carrying groceries |
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| No, not limited at all...3 |
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| (4 weeks) Q3d. Climbing several flights of stairs |
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| No, not limited at all...3 |
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| (4 weeks) Q3e. Climbing one flight of stairs |
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| No, not limited at all...3 |
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| (4 weeks) Q3f. Bending, kneeling, or stooping |
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| No, not limited at all...3 |
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| (4 weeks) Q3g. Walking more than a mile |
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| No, not limited at all...3 |
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| (4 weeks) Q3h. Walking several blocks |
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| No, not limited at all...3 |
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| (4 weeks) Q3i. Walking one block |
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| No, not limited at all...3 |
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| (4 weeks) Q3j. Bathing or dressing yourself |
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| (4 weeks) Q4a. Cut down the amount of time you spent on work or other activities |
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| (4 weeks) Q4b. Accomplished less than you would like |
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| (4 weeks) Q4c. Were limited in the kind of work or other activities |
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| (4 weeks) Q4d. Had difficulty performing the work or other activities |
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| (4 weeks) Q5a. Cut down the amount of time you spent on work or other activities |
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| (4 weeks) Q5b. Accomplished less than you would like |
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| (4 weeks) Q5c. Didn't do work or other activities as carefully as usual |
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| Moderately...3 |
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| Quite a bit...4 |
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| Extremely...5 |
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| (4 weeks) Q6. |
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| Mild...3 |
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| Moderate...4 |
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| Severe...5 |
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| Very Severe...6 |
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| (4 weeks) Q7. How much bodily pain have you had during the past four weeks? |
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| Moderately...3 |
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| Quite a bit...4 |
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| Extremely...5 |
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| (4 weeks) Q8. During the past 4weeks, how much did pain interfere with your normal work? |
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| A good bit of the time...3 |
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| Some of the time...4 |
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| A little of the time...5 |
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| None of the time...6 |
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| (4 weeks) Q9a. Did you feel full of pep? |
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| A good bit of the time...3 |
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| Some of the time...4 |
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| A little of the time...5 |
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| None of the time...6 |
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| (4 weeks) Q9b. Have you been a very nervous person? |
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| A good bit of the time...3 |
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| Some of the time...4 |
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| A little of the time...5 |
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| None of the time...6 |
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| (4 weeks) Q9c. Have you felt so down in the dumps that nothing could cheer you up? |
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| A good bit of the time...3 |
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| Some of the time...4 |
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| A little of the time...5 |
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| None of the time...6 |
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| (4 weeks) Q9d. Have you felt calm and peaceful? |
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| A good bit of the time...3 |
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| Some of the time...4 |
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| A little of the time...5 |
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| None of the time...6 |
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| (4 weeks) Q9e. Did you have a lot of energy? |
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| A good bit of the time...3 |
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| Some of the time...4 |
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| A little of the time...5 |
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| None of the time...6 |
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| (4 weeks) Q9f. Have you felt down hearted and blue? |
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| A good bit of the time...3 |
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| Some of the time...4 |
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| A little of the time...5 |
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| None of the time...6 |
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| (4 weeks) Q9g. Did you feel worn out? |
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| A good bit of the time...3 |
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| Some of the time...4 |
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| A little of the time...5 |
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| None of the time...6 |
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| (4 weeks) Q9h. Have you been a happy person? |
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| A good bit of the time...3 |
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| Some of the time...4 |
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| A little of the time...5 |
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| None of the time...6 |
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| (4 weeks) Q9i. Did you feel tired? |
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| A good bit of the time...3 |
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| Some of the time...4 |
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| A little of the time...5 |
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| None of the time...6 |
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| (4 weeks) Q9j. |
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| Don't know...3 |
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| Mostly false...4 |
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| Definitely false...5 |
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| (4 weeks) Q10a. I seem to get sick a little easier than other people |
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| Don't know...3 |
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| Mostly false...4 |
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| Definitely false...5 |
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| (4 weeks) Q10b. I am as healthy as anybody I know |
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| Don't know...3 |
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| Mostly false...4 |
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| Definitely false...5 |
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| (4 weeks) Q10c. I expect my health to get worse |
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| Don't know...3 |
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| Mostly false...4 |
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| Definitely false...5 |
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| (4 weeks) Q10d. My health is excellent |
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