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| Name | Class |
|---|---|
| Brown University | OTHER |
| University of Pittsburgh | OTHER |
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The purpose of the study was to examine the effectiveness of an expert-system, print-based physical activity (PA) intervention delivered to Veterans receiving primary care at the VA Pittsburgh Healthcare System (VAPHS).
A.1 The primary aim of the study was to determine the effect of a physical activity intervention designed to increase physical activity for sedentary Veterans at VAPHS.
A.2. Secondary aims were to assess key health-related outcomes related to the intervention including health and quality of life. The specific outcomes were to (a) estimate the impact of the intervention on physical function, health-related quality of life (HRQL), weight, blood pressure, and serum lipids; and (b) characterize variation in intervention effectiveness by participant sociodemographic and health characteristics, such as age, race, and baseline health status.
232 Veterans were randomized to either the physical activity intervention group or the attention control group. Participants randomized to the physical activity intervention group participated in an individualized physical activity counseling session at baseline, conducted by an exercise physiologist, with guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity. An additional 14 intervention counseling contacts, generated by participants' responses to physical activity questionnaires and individually tailored computer-generated expert system feedback messages based on stages of the motivational readiness for change model, were conducted via postal mail over the subsequent 12 months in parallel with routine primary care. Newsletters providing additional support and suggestions for increasing physical activity were also part of the mailed counseling contacts. Participants randomized to the attention control group participated in a generalized healthy lifestyle counseling session at baseline, conducted by a health educator, which included limited advice to become more physically active. Fourteen follow-up wellness newsletters that focused on healthy lifestyle issues other than physical activity were sent to participants via postal mail over the subsequent 12 months with the same frequency of contact as for the physical activity intervention group and in parallel with routine primary care. Assessment of effectiveness occurred at baseline, 6, and 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical Activity Intervention | Experimental | Expert system-based physical activity counseling: Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model |
|
| Attention Control | No Intervention | Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Expert system-based physical activity counseling | Behavioral | The intervention included 14 mailings to participants that involved completion of physical activity questionnaires printed on forms that were scanned into a computerized expert system program to generate individually-tailored feedback messages and related manuals based on the Stages of Motivational Readiness for Change Model. Newsletters providing additional support and suggestions for increasing physical activity were also part of the mailing program. |
| Measure | Description | Time Frame |
|---|---|---|
| Moderate Intensity Physical Activity: Modified Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire | Participants achieving 150 minutes/week of moderate intensity or greater physical activity at Month 0 as measured with the modified CHAMPS Questionnaire | Month 0 |
| Moderate Intensity Physical Activity: Modified CHAMPS Questionnaire | Participants achieving 150 minutes/week of moderate intensity or greater physical activity at Month 6 as measured with the modified CHAMPS Questionnaire | Month 6 |
| Moderate Intensity Physical Activity: Modified CHAMPS Questionnaire | Participants achieving 150 minutes/week of moderate intensity or greater physical activity at Month 12 as measured with the modified CHAMPS Questionnaire | Month 12 |
| Moderate Intensity Physical Activity: Accelerometer | Participants with an average of at least 30 minutes/day of moderate intensity or greater physical activity in a subset of the study population for whom accelerometer data were obtained: 97 of 116 in Physical Activity Intervention Group and 103 of 116 in Attention Control Group at Month 0 | Month 0 |
| Moderate Intensity Physical Activity: Accelerometer | Participants with an average of at least 30 minutes/day of moderate intensity or greater physical activity in a subset of the study population for whom accelerometer data were obtained: 77 of 101 in Physical Activity Intervention Group and 76 of 107 in Attention Control Group in Month 6 | Month 6 |
| Moderate Intensity Physical Activity: Accelerometer |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Weight in kilograms (kg) measured at Month 0 | Month 0 |
| Weight | Weight in kilograms at measured at Month 6 | Month 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Ann Sevick, ScD MS | VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | Pittsburgh | Pennsylvania | 15240 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24398076 | Result | Hawkins MS, Hough LJ, Berger MA, Mor MK, Steenkiste AR, Gao S, Stone RA, Burkitt KH, Marcus BH, Ciccolo JT, Kriska AM, Klinvex DT, Sevick MA. Recruitment of veterans from primary care into a physical activity randomized controlled trial: the experience of the VA-STRIDE study. Trials. 2014 Jan 7;15:11. doi: 10.1186/1745-6215-15-11. | |
| 26844197 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Physcial Activity Intervention | Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model |
| FG001 | Attention Control | Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Physcial Activity Intervention | Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Moderate Intensity Physical Activity: Modified Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire | Participants achieving 150 minutes/week of moderate intensity or greater physical activity at Month 0 as measured with the modified CHAMPS Questionnaire | Posted | Number | participants | Month 0 |
|
Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
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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 | Physical Activity Intervention | Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelly Hyman Burkitt, PhD | VA Pittsburgh Healthcare System | 412-360-2202 | Kelly.Burkitt@va.gov |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D057185 | Sedentary Behavior |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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|
Participants with an average of at least 30 minutes/day of moderate intensity or greater physical activity in a subset of the study population for whom accelerometer data were obtained: 71 of 98 in Physical Activity Intervention Group and 74 of 105 in Attention Control Group at Month 12
| Month 12 |
| Weight | Weight in kilograms measured at Month 12 | Month 12 |
| Systolic Blood Pressure (BP) | Systolic BP in millimeters of mercury (mmHg) measured at Month 0 | Month 0 |
| Systolic BP | Systolic BP measured at Month 6 | Month 6 |
| Systolic BP | Systolic BP measured at Month 12 | Month 12 |
| Diastolic BP | Diastolic BP measured at Month 0 | Month 0 |
| Diastolic BP | Diastolic BP measured at Month 6 | Month 6 |
| Diastolic BP | Diastolic BP measured at Month 12 | Month 12 |
| Low-density Lipoprotein (LDL) Cholesterol | LDL cholesterol in milligrams per deciliter (mg/dL) measured at Month 0 | Month 0 |
| LDL Cholesterol | LDL cholesterol measured at Month 6 | Month 6 |
| LDL Cholesterol | LDL cholesterol measured at Month 12 | Month 12 |
| High-density Lipoprotein (HDL) Cholesterol | HDL cholesterol in milligrams/deciliter (mg/dL) measured at Month 0 | Month 0 |
| HDL Cholesterol | HDL cholesterol measured at Month 6 | Month 6 |
| HDL Cholesterol | HDL cholesterol measured at Month 12 | Month 12 |
| Triglycerides | Triglycerides measured at Month 0 | Month 0 |
| Triglycerides | Triglycerides measured at Month 6 | Month 6 |
| Triglycerides | Triglycerides measured at Month 12 | Month 12 |
| Health Related Quality of Life (HRQL): Short Form 36 Health Survey Questionnaire (SF-36) Physical Component Summary Measure (PCS) | HRQL: SF-36 PCS measured at Month 0. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The PCS aggregates the scales for bodily pain, general health perceptions, physical functioning, and role limitation due to physical health problems. | Month 0 |
| HRQL: SF-36 PCS | HRQL: SF-36 PCS measured at Month 6. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The PCS aggregates the scales for bodily pain, general health perceptions, physical functioning, and role limitation due to physical health problems. | Month 6 |
| HRQL: SF-36 PCS | HRQL: SF-36 PCS measured at Month 12. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The PCS aggregates the scales for bodily pain, general health perceptions, physical functioning, and role limitation due to physical health problems. | Month 12 |
| HRQL: SF-36 Mental Component Summary Measure (MSC) | HRQL: SF-36 MCS measured at Month 0. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The MCS aggregates the scales for vitality, mental health, social functioning, and role limitations due to personal or emotional problems. | Month 0 |
| HRQL: SF-36 MCS | HRQL: SF-36 MCS measured at Month 6. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The MCS aggregates the scales for vitality, mental health, social functioning, and role limitations due to personal or emotional problems. | Month 6 |
| HRQL: SF-36 MCS | HRQL: SF-36 MCS measured at Month 12. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The MCS aggregates the scales for vitality, mental health, social functioning, and role limitations due to personal or emotional problems. | Month 12 |
| Physical Function: 6-Minute Walking Distance (6MWD) | Physical Function: 6MWD in meters measured at Month 0 | Month 0 |
| Physical Function: 6MWD | Physical Function: 6MWD measured at Month 6 | Month 6 |
| Physical Function: 6MWD | Physical Function: 6MWD measured at Month 12 | Month 12 |
| Gao S, Stone RA, Hough LJ, Haibach JP, Marcus BH, Ciccolo JT, Kriska AM, Burkitt KH, Steenkiste AR, Berger MA, Sevick MA. Physical activity counseling in overweight and obese primary care patients: Outcomes of the VA-STRIDE randomized controlled trial. Prev Med Rep. 2015 Dec 21;3:113-20. doi: 10.1016/j.pmedr.2015.12.007. eCollection 2016 Jun. |
| BG001 | Attention Control | Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
|
| Attention Control |
Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity |
|
|
| Primary | Moderate Intensity Physical Activity: Modified CHAMPS Questionnaire | Participants achieving 150 minutes/week of moderate intensity or greater physical activity at Month 6 as measured with the modified CHAMPS Questionnaire | Posted | Number | participants | Month 6 |
|
|
|
| Primary | Moderate Intensity Physical Activity: Modified CHAMPS Questionnaire | Participants achieving 150 minutes/week of moderate intensity or greater physical activity at Month 12 as measured with the modified CHAMPS Questionnaire | Posted | Number | participants | Month 12 |
|
|
|
| Primary | Moderate Intensity Physical Activity: Accelerometer | Participants with an average of at least 30 minutes/day of moderate intensity or greater physical activity in a subset of the study population for whom accelerometer data were obtained: 97 of 116 in Physical Activity Intervention Group and 103 of 116 in Attention Control Group at Month 0 | Posted | Number | participants | Month 0 |
|
|
|
| Primary | Moderate Intensity Physical Activity: Accelerometer | Participants with an average of at least 30 minutes/day of moderate intensity or greater physical activity in a subset of the study population for whom accelerometer data were obtained: 77 of 101 in Physical Activity Intervention Group and 76 of 107 in Attention Control Group in Month 6 | Posted | Number | participants | Month 6 |
|
|
|
| Primary | Moderate Intensity Physical Activity: Accelerometer | Participants with an average of at least 30 minutes/day of moderate intensity or greater physical activity in a subset of the study population for whom accelerometer data were obtained: 71 of 98 in Physical Activity Intervention Group and 74 of 105 in Attention Control Group at Month 12 | Posted | Number | participants | Month 12 |
|
|
|
| Secondary | Weight | Weight in kilograms (kg) measured at Month 0 | Posted | Mean | Standard Deviation | kg | Month 0 |
|
|
|
| Secondary | Weight | Weight in kilograms at measured at Month 6 | Posted | Mean | Standard Deviation | kg | Month 6 |
|
|
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| Secondary | Weight | Weight in kilograms measured at Month 12 | Posted | Mean | Standard Deviation | kg | Month 12 |
|
|
|
| Secondary | Systolic Blood Pressure (BP) | Systolic BP in millimeters of mercury (mmHg) measured at Month 0 | Posted | Mean | Standard Deviation | mmHg | Month 0 |
|
|
|
| Secondary | Systolic BP | Systolic BP measured at Month 6 | Posted | Mean | Standard Deviation | mmHg | Month 6 |
|
|
|
| Secondary | Systolic BP | Systolic BP measured at Month 12 | Posted | Mean | Standard Deviation | mmHg | Month 12 |
|
|
|
| Secondary | Diastolic BP | Diastolic BP measured at Month 0 | Posted | Mean | Standard Deviation | mmHg | Month 0 |
|
|
|
| Secondary | Diastolic BP | Diastolic BP measured at Month 6 | Posted | Mean | Standard Deviation | mmHg | Month 6 |
|
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| Secondary | Diastolic BP | Diastolic BP measured at Month 12 | Posted | Mean | Standard Deviation | mmHg | Month 12 |
|
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| Secondary | Low-density Lipoprotein (LDL) Cholesterol | LDL cholesterol in milligrams per deciliter (mg/dL) measured at Month 0 | Posted | Mean | Standard Deviation | mg/dL | Month 0 |
|
|
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| Secondary | LDL Cholesterol | LDL cholesterol measured at Month 6 | Posted | Mean | Standard Deviation | mg/dL | Month 6 |
|
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| Secondary | LDL Cholesterol | LDL cholesterol measured at Month 12 | Posted | Mean | Standard Deviation | mg/dL | Month 12 |
|
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| Secondary | High-density Lipoprotein (HDL) Cholesterol | HDL cholesterol in milligrams/deciliter (mg/dL) measured at Month 0 | Posted | Mean | Standard Deviation | mg/dL | Month 0 |
|
|
|
| Secondary | HDL Cholesterol | HDL cholesterol measured at Month 6 | Posted | Mean | Standard Deviation | mg/dL | Month 6 |
|
|
|
| Secondary | HDL Cholesterol | HDL cholesterol measured at Month 12 | Posted | Mean | Standard Deviation | mg/dL | Month 12 |
|
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|
| Secondary | Triglycerides | Triglycerides measured at Month 0 | Posted | Mean | Standard Deviation | mg/dL | Month 0 |
|
|
|
| Secondary | Triglycerides | Triglycerides measured at Month 6 | Posted | Mean | Standard Deviation | mg/dL | Month 6 |
|
|
|
| Secondary | Triglycerides | Triglycerides measured at Month 12 | Posted | Mean | Standard Deviation | mg/dL | Month 12 |
|
|
|
| Secondary | Health Related Quality of Life (HRQL): Short Form 36 Health Survey Questionnaire (SF-36) Physical Component Summary Measure (PCS) | HRQL: SF-36 PCS measured at Month 0. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The PCS aggregates the scales for bodily pain, general health perceptions, physical functioning, and role limitation due to physical health problems. | Posted | Mean | Standard Deviation | scores on a scale | Month 0 |
|
|
|
| Secondary | HRQL: SF-36 PCS | HRQL: SF-36 PCS measured at Month 6. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The PCS aggregates the scales for bodily pain, general health perceptions, physical functioning, and role limitation due to physical health problems. | Posted | Mean | Standard Deviation | scores on a scale | Month 6 |
|
|
|
| Secondary | HRQL: SF-36 PCS | HRQL: SF-36 PCS measured at Month 12. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The PCS aggregates the scales for bodily pain, general health perceptions, physical functioning, and role limitation due to physical health problems. | Posted | Mean | Standard Deviation | scores on a scale | Month 12 |
|
|
|
| Secondary | HRQL: SF-36 Mental Component Summary Measure (MSC) | HRQL: SF-36 MCS measured at Month 0. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The MCS aggregates the scales for vitality, mental health, social functioning, and role limitations due to personal or emotional problems. | Posted | Mean | Standard Deviation | scores on a scale | Month 0 |
|
|
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| Secondary | HRQL: SF-36 MCS | HRQL: SF-36 MCS measured at Month 6. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The MCS aggregates the scales for vitality, mental health, social functioning, and role limitations due to personal or emotional problems. | Posted | Mean | Standard Deviation | scores on a scale | Month 6 |
|
|
|
| Secondary | HRQL: SF-36 MCS | HRQL: SF-36 MCS measured at Month 12. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The MCS aggregates the scales for vitality, mental health, social functioning, and role limitations due to personal or emotional problems. | Posted | Mean | Standard Deviation | scores on a scale | Month 12 |
|
|
|
| Secondary | Physical Function: 6-Minute Walking Distance (6MWD) | Physical Function: 6MWD in meters measured at Month 0 | Posted | Mean | Standard Deviation | meters | Month 0 |
|
|
|
| Secondary | Physical Function: 6MWD | Physical Function: 6MWD measured at Month 6 | Posted | Mean | Standard Deviation | meters | Month 6 |
|
|
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| Secondary | Physical Function: 6MWD | Physical Function: 6MWD measured at Month 12 | Posted | Mean | Standard Deviation | meters | Month 12 |
|
|
|
| 29 |
| 116 |
| 0 |
| 116 |
| EG001 | Attention Control | Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity | 33 | 116 | 0 | 116 |
| Cardiac catheterization | Cardiac disorders | Systematic Assessment |
|
| Chest pains/pressure | Cardiac disorders | Systematic Assessment |
|
| Acid reflux/vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
|
| Gallbladder problems | Hepatobiliary disorders | Systematic Assessment |
|
| Allergic reaction | Immune system disorders | Systematic Assessment |
|
| Ear infection | Infections and infestations | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Eye trauma | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Sleep apnea | Investigations | Systematic Assessment |
|
| Vertigo | Investigations | Systematic Assessment |
|
| Nerve pain | Nervous system disorders | Systematic Assessment |
|
| Anxiety/stress | Psychiatric disorders | Systematic Assessment |
|
| Kidney stones | Renal and urinary disorders | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Fluid retention in leg | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Cataract surgery | Surgical and medical procedures | Systematic Assessment |
|
| Colectomy | Surgical and medical procedures | Systematic Assessment |
|
| Hernia surgery | Surgical and medical procedures | Systematic Assessment |
|
| Knee/ankle surgery | Surgical and medical procedures | Systematic Assessment |
|
| Lymphadenectomy | Surgical and medical procedures | Systematic Assessment |
|
| Pacemaker inserted | Surgical and medical procedures | Systematic Assessment |
|
| Prostate surgery | Surgical and medical procedures | Systematic Assessment |
|
| Shoulder surgery | Surgical and medical procedures | Systematic Assessment |
|
| Transient ischemic attack | Vascular disorders | Systematic Assessment |
|
Not provided
Not provided
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |