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Low mobility, defined as being limited to bed or chair, is common during acute hospitalization. This study will evaluate the impact and safety of a hospital walking program for older patients during acute general medical hospitalization. Participants who are 65 years of age or older, will be randomized to usual care (UC) or to a hospital walking program (WP), which includes twice daily walks with assistance, provision of necessary ambulatory devices, and a behavioral intervention strategy designed to encourage out of bed activity. Throughout hospitalization, the WP and UC veterans will were wireless monitors on the thigh and ankle that measure activity. The primary goal will be in increase the length of time veterans spend out of bed and to assure this out of bed activity is safe.
Background: Low mobility, defined as being limited to bed or chair, is common during acute hospitalization. The candidate's work has demonstrated low mobility to be associated with adverse outcomes including functional decline, need for new nursing home admission, and death even after controlling for illness severity and comorbidity. Objective: Using a Phase II trial design, the impact and safety of a hospital walking program for older patients during acute general medical hospitalization will be evaluated.
Project Design: 100 patients, age 65 years admitted to the medical wards at the Birmingham VAMC will be recruited within 48 hours of hospitalization and followed for 14 days after enrollment or until discharge, which ever comes first. Exclusion criteria will include: (1) Delirious based on positive Confusion Assessment Method (CAM); (2) Mini Mental State Examination Score < 17; (3) Patient on isolation; (4) Inability to ambulate 2 weeks prior to admission; (5) Having a medical diagnosis deemed by the primary physician to be a contraindication to ambulation; (6) patient with an imminently terminal illness; and (7) Non-English speaking. Participants will be randomized to either usual care (UC) or to a hospital walking program (WP), which includes twice daily walks with assistance, provision of necessary ambulatory devices, and a behavioral intervention strategy designed to encourage out of bed activity. Throughout hospitalization, the WP and UC veterans will wear on the ipsilateral thigh and ankle wireless monitors that measure horizontal and vertical orientation with respect to gravity. Previously validated by the candidate to assess levels of mobility during hospitalization, the output will be used to calculate the length of time patients spent lying, sitting, and standing or walking, using pre-defined criteria. Other daily measures will include orthostatic blood pressure, functional assessments, and assessment of falls and symptoms over the previous 24-hours. The primary outcome measure is time out of bed as measured by the wireless monitors. Importantly, our goal is to assess not only the amount of mobility that occurred as a result of the hospital walking program but that which occurred beyond the intervention. In our previous VA-funded study, patients spent an average of 17.1% or 4.1 hours out of bed per 24-hour period of time (s.d. 2.9). Our goal is to increase this by 50% or 2 hours to an average of 6.1 hours. This results in an effect size of 0.69 standard deviation units. A sample size of 45 per group provides 90% power to detect this 2-hour difference in the amount of time patients spend out of bed at the = .05 level.
Significance: at present there is a paucity of data regarding the impact or safety of a hospital walking program for general medical patients. Results of this study will enable researchers to determine the safety and efficacy of the walking program for older veterans during hospitalization and will provide information regarding effect size for a definitive intervention trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobility Group | Active Comparator | The Walking Intervention includes assistance to walk twice daily with or without a rolling walker. In addition, a behavioral intervention that included goal setting and discussion of how to overcome mobility barriers was used to encourage the mobility group to be more active throughout hospital stay. Participants will keep a diary of out of bed activity and will be encouraged to set goals for additional out of bed activity daily. |
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| Control Group | Placebo Comparator | The control group will receive twice daily friendly visits to counter the attention being paid to the intervention group. They will complete a diary but of visitors to their room. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral intervention | Behavioral | Using social cognitive theory, participants in the walking program group will be encouraged to complete a brief diary about out of bed activities like sitting up for meals of walks to the bathroom. They will be provided with information regarding the importance of being out of bed a praise for any attempts. They will be asked to set out of bed time activity goals daily. The control group will have a diary to track visitors. |
| Measure | Description | Time Frame |
|---|---|---|
| Falls | Patients were asked daily during hospitalization to self-report any falls | 18 months |
| Amount of Time Spent Out of Bed as Measured by Wireless Accelerometers | Throughout the hospital stay, both the WP and UC patient wore a triaxial accelerometer on the ipsilateral thigh and ankle. The patient's skin was assessed regularly to assure there is no evidence of irritation. The wireless monitors were used to quantify the amount of mobility that occurs daily for each patient with researchers being blinded to the outcome. | During hospital stay |
| Measure | Description | Time Frame |
|---|---|---|
| Life-Space Assessment Score | The UAB Study of Aging Life-Space Assessment (LSA) is a validated tool that measures mobility and function based on the distance which a person reports moving during the four weeks preceding the assessment. Life-space "levels" range from within one's dwelling to beyond one's town. A life-space composite score is calculated based on life-space level, degree of independence in achieving each level, and the frequency of attaining each level. Scores range from 0 - 120 with higher scores indicating greater community mobility. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia J. Brown, MD MSPH | VA Medical Center, Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Medical Center, Birmingham | Birmingham | Alabama | 35233 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27243899 | Derived | Brown CJ, Foley KT, Lowman JD Jr, MacLennan PA, Razjouyan J, Najafi B, Locher J, Allman RM. Comparison of Posthospitalization Function and Community Mobility in Hospital Mobility Program and Usual Care Patients: A Randomized Clinical Trial. JAMA Intern Med. 2016 Jul 1;176(7):921-7. doi: 10.1001/jamainternmed.2016.1870. |
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Persons interested in obtaining the dataset will be asked to complete a data sharing agreement and procure IRB approval from their institution. At that time a de-identified dataset will be provided to them.
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Inclusion criteria were: having a negative screen for cognitive impairment (Mini Cog score ≥ 3), not being delirious (CAM score=0), self-report of being ambulatory with or without an assistive device in the 2 weeks before admission, not having a significant language barrier requiring a translator, and not previously enrolled in the study.
Participants were patients 65 years or older admitted to the medical wards of the Birmingham Veterans Affairs Medical Center from January 12, 2010 to June 29, 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mobility Group | Participants will receive assistance to walk twice daily, plus encouragement to be more active throughout hospital stay. Participants will keep a diary of out of bed activity and will be encouraged to set goals for additional out of bed activity daily. Behavioral encouragement of out of bed activity: Using social cognitive theory, participants in the walking program group will be encouraged to complete a brief diary about out of bed activities like sitting up for meals of walks to the bathroom. They will be provided with information regarding the importance of being out of bed a praise for any attempts. They will be asked to set out of bed time activity goals daily. The control group will have a diary to track visitors. Walking Intervention: Participants in the walking program will be assisted to walk twice a day by trained staff. Those in the control group will be visited twice a day for friendly visits only |
| FG001 | Control Group | The control group will receive twice daily friendly visits. They will complete a diary but of visitors to their room. Friendly visits: The control group will receive twice daily friendly visits and will be asked to complete a diary each day of the people who visit them in the hospital. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants were 100 patients aged 65 years or older admitted to the medical wards of the Birmingham Veterans Affairs Medical Center (BVAMC).
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| ID | Title | Description |
|---|---|---|
| BG000 | Mobility Group | Participants will receive assistance to walk twice daily, plus encouragement to be more active throughout hospital stay. Participants will keep a diary of out of bed activity and will be encouraged to set goals for additional out of bed activity daily. Behavioral encouragement of out of bed activity: Using social cognitive theory, participants in the walking program group will be encouraged to complete a brief diary about out of bed activities like sitting up for meals of walks to the bathroom. They will be provided with information regarding the importance of being out of bed a praise for any attempts. They will be asked to set out of bed time activity goals daily. The control group will have a diary to track visitors. Walking Intervention: Participants in the walking program will be assisted to walk twice a day by trained staff. Those in the control group will be visited twice a day for friendly visits only |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Falls | Patients were asked daily during hospitalization to self-report any falls | Posted | Number | participants | 18 months |
|
18 months
To assess the safety of the walking intervention both UC and WP patients will be asked daily about the occurrence of falls in the previous 24-hours.
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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 | Mobility Group | Participants will receive assistance to walk twice daily, plus encouragement to be more active throughout hospital stay. Participants will keep a diary of out of bed activity and will be encouraged to set goals for additional out of bed activity daily. Behavioral encouragement of out of bed activity: Using social cognitive theory, participants in the walking program group will be encouraged to complete a brief diary about out of bed activities like sitting up for meals of walks to the bathroom. They will be provided with information regarding the importance of being out of bed a praise for any attempts. They will be asked to set out of bed time activity goals daily. The control group will have a diary to track visitors. Walking Intervention: Participants in the walking program will be assisted to walk twice a day by trained staff. Those in the control group will be visited twice a day for friendly visits only |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin irritation | Skin and subcutaneous tissue disorders | Skin irritation | Systematic Assessment | To address the small risk of skin irritation, a gauze was used between the skin and the device and check the device at least daily for placement and signs of erythema and the device was moved to the opposite limb daily. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall post-hospitalization | Musculoskeletal and connective tissue disorders | Falls | Systematic Assessment | Patients were asked to report on any falls that occurred after hospital discharge. |
Study may not be generalizable as subjects mostly male and not demented or delirious. Study sample is small and needs to be replicated in a larger cohort.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cynthia J. Brown, MD, MSPH | Birmingham VAMC | 205-933-8101 | 7300 | cynthia.brownd44b2@va.gov |
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| ID | Term |
|---|---|
| D000208 | Acute Disease |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Walking Intervention | Other | Participants in the walking program will be assisted to walk twice a day by trained staff. Those in the control group will be visited twice a day for friendly visits only |
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| Friendly visits | Other | The control group will receive twice daily friendly visits and will be asked to complete a diary each day of the people who visit them in the hospital. |
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| 4-6 weeks after baseline |
| BG001 | Control Group | The control group will receive twice daily friendly visits. They will complete a diary but of visitors to their room. Friendly visits: The control group will receive twice daily friendly visits and will be asked to complete a diary each day of the people who visit them in the hospital. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Mobility Knowledge PreTest Score | Scale range 0-5 with higher scores indicating higher knowledge regarding importance of mobility during hospitalization. | Mean | Standard Deviation | units on a scale |
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| Falls Self-Efficacy | The participant was asked "On a scale from 1 to 10, with 1 being very confident and 10 being not confident at all, how confident are you that you can do the following activities without falling?". Each item is scored from 1 to 10, and the responses are summed for all 10 questions. The Falls Self-efficacy scale scores range from 10 - 100 with higher scores indicating lower confidence in ability to perform 10 different activities without falling. | Mean | Standard Deviation | units on a scale |
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| Activities of Daily Living (ADL) 2 Weeks prior to admission | At baseline, patients were asked to rate their level of independence with 6 activities of daily living (feeding, bathing, dressing, toileting, transferring, and walking) in the two weeks prior to their hospital admission. They were asked if they were independent (score =1), needed some assistance (score = 2) or required total assistance with the activity (score = 3). Scores for all 6 ADLs were summed with a range of 6-18 with higher scores indicating less independence with ADLs. | Mean | Standard Deviation | units on a scale |
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| ADL on Admission | At baseline, patients were asked to rate their current level of independence with six activities of daily living (feeding, bathing, dressing, toileting, transferring, and walking). They were asked if they were independent (score =1), needed some assistance (score = 2) or required total assistance with the activity (score = 3). Scores for each of the 6 ADLs were summed; scores ranged from 6-18 with higher scores indicating less independence with ADLs. | Mean | Standard Deviation | units on a scale |
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| Life-Space Assessment score | The UAB Study of Aging Life-Space Assessment (LSA) is a validated tool that measures mobility and function based on the distance which a person reports moving during the four weeks preceding the assessment. Scores range from 0 - 120 with higher scores reflecting higher levels of community mobility. | Mean | Standard Deviation | units on a scale |
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| Mini-Nutritional Assessment score | The Mini-Nutritional Assessment (MNA) is a 6-item screening test of risk for malnutrition. Responses to the questions are summed to provide a score, with a range from 0-14. 12-14 points: Normal nutritional status 8-11 points: At risk of malnutrition 0-7 points: Malnourished | Mean | Standard Deviation | units on a scale |
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| Short Nutritional Assessment Questionnaire (SNAQ) score | This 4-item questionnaire is used to determine risk of weight loss. Each question is scored from 1-5 and the questions are summed to give a SNAQ score. Scores range from 4 - 20 and SNAQ scores of ≤14 indicate significant risk of at least 5 % weight loss within six months. | Mean | Standard Deviation | units on a scale |
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| Gait speed | If able to walk a short distance, patients were asked to perform a timed 10-foot (3 meter) walk. Two walks were done with the faster of the two times being utilized for analysis. Gait speeds of > or = to 1.0 meters/sec are considered normal; slower gait speeds are associated with increased risk of adverse outcomes including falls, ADL decline, nursing home placement and death. | Mean | Standard Deviation | meters per second |
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| Geriatric Depression Scale (GDS) | The Geriatric Depression Scale-short form is a 15-item questionnaire to screen for the presence of depression. Answers to the 15 "yes or no" questions are summed with scores of 6 or greater being identified as a positive screen for depression. | Mean | Standard Deviation | units on a scale |
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| OG001 | Control Group | The control group will receive twice daily friendly visits. They will complete a diary but of visitors to their room. Friendly visits: The control group will receive twice daily friendly visits and will be asked to complete a diary each day of the people who visit them in the hospital. |
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| Secondary | Life-Space Assessment Score | The UAB Study of Aging Life-Space Assessment (LSA) is a validated tool that measures mobility and function based on the distance which a person reports moving during the four weeks preceding the assessment. Life-space "levels" range from within one's dwelling to beyond one's town. A life-space composite score is calculated based on life-space level, degree of independence in achieving each level, and the frequency of attaining each level. Scores range from 0 - 120 with higher scores indicating greater community mobility. | Posted | Mean | Standard Deviation | units on a scale | 4-6 weeks after baseline |
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| Primary | Amount of Time Spent Out of Bed as Measured by Wireless Accelerometers | Throughout the hospital stay, both the WP and UC patient wore a triaxial accelerometer on the ipsilateral thigh and ankle. The patient's skin was assessed regularly to assure there is no evidence of irritation. The wireless monitors were used to quantify the amount of mobility that occurs daily for each patient with researchers being blinded to the outcome. | Only data from those recording days during which sensors were worn for at least 12 hours, defined as a valid day recording, were considered for final analysis. The average out of bed activity (standing or walking) duration over valid days of recording for each person was reported. | Posted | Mean | Standard Deviation | minutes/day | During hospital stay |
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| 8 |
| 50 |
| 5 |
| 50 |
| EG001 | Control Group | The control group will receive twice daily friendly visits. They will complete a diary but of visitors to their room. Friendly visits: The control group will receive twice daily friendly visits and will be asked to complete a diary each day of the people who visit them in the hospital. | 8 | 50 | 5 | 50 |
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| In hospital Falls | Musculoskeletal and connective tissue disorders | Falls | Systematic Assessment | Patients self-reported on falls in the prior 24 hours |
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| Readmission | Surgical and medical procedures | Readmission | Systematic Assessment | Readmission to the hospital within 30 days of discharge |
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| Death | Surgical and medical procedures | Death | Systematic Assessment |
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| ICU Transfer | Surgical and medical procedures | ICU Transfer | Systematic Assessment |
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