Efficacy and Safety of a Hospital Walking Program for Older Adults
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Mobility Group 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. |
Behavioral: Behavioral intervention
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.
Other: 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
|
| Placebo Comparator: Control Group 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. |
Other: 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.
|
Outcome Measures
Primary Outcome Measures
- Falls [18 months]
Patients were asked daily during hospitalization to self-report any falls
- Amount of Time Spent Out of Bed as Measured by Wireless Accelerometers [During hospital stay]
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.
Secondary Outcome Measures
- Life-Space Assessment Score [4-6 weeks after baseline]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age greater or equal to 65 years;
-
Admitted to the Birmingham VAMC for a medical condition
Exclusion Criteria:
-
Delirious based on positive Confusion Assessment Method (CAM);
-
Mini-Cognitive Assessment score indicating dementia;
-
Inability to ambulate 2 weeks prior to admission;
-
Having a medical diagnosis deemed by the primary physician to be a contraindication to ambulation;
-
patient with an imminently terminal illness; and
-
Non-English speaking
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VA Medical Center, Birmingham | Birmingham | Alabama | United States | 35233 |
Sponsors and Collaborators
- VA Office of Research and Development
Investigators
- Principal Investigator: Cynthia J. Brown, MD MSPH, VA Medical Center, Birmingham
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- E6326-W
Study Results
Participant Flow
| Recruitment Details | 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. |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | Mobility Group | Control Group |
|---|---|---|
| Arm/Group Description | 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 | 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. |
| Period Title: Overall Study | ||
| STARTED | 50 | 50 |
| COMPLETED | 44 | 48 |
| NOT COMPLETED | 6 | 2 |
Baseline Characteristics
| Arm/Group Title | Mobility Group | Control Group | Total |
|---|---|---|---|
| Arm/Group Description | 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 | 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. | Total of all reporting groups |
| Overall Participants | 50 | 50 | 100 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
0
0%
|
0
0%
|
0
0%
|
| >=65 years |
50
100%
|
50
100%
|
100
100%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
2
4%
|
1
2%
|
3
3%
|
| Male |
48
96%
|
49
98%
|
97
97%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
11
22%
|
8
16%
|
19
19%
|
| White |
39
78%
|
42
84%
|
81
81%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
50
100%
|
50
100%
|
100
100%
|
| Mobility Knowledge PreTest Score (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
2.4
(1.1)
|
2.6
(1.1)
|
2.5
(1.1)
|
| Falls Self-Efficacy (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
15.8
(6.5)
|
15.8
(6.2)
|
15.8
(6.3)
|
| Activities of Daily Living (ADL) 2 Weeks prior to admission (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
7.96
(1.5)
|
8.0
(1.8)
|
8.0
(1.6)
|
| ADL on Admission (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
8.8
(2.7)
|
9.1
(2.9)
|
8.9
(2.8)
|
| Life-Space Assessment score (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
53.9
(29.4)
|
51.5
(21.1)
|
52.7
(25.5)
|
| Mini-Nutritional Assessment score (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
9.4
(2.6)
|
9.0
(2.3)
|
9.2
(2.4)
|
| Short Nutritional Assessment Questionnaire (SNAQ) score (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
13.7
(3.4)
|
13.5
(3.3)
|
13.6
(3.3)
|
| Gait speed (meters per second) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [meters per second] |
0.50
(0.26)
|
0.51
(0.26)
|
0.51
(0.26)
|
| Geriatric Depression Scale (GDS) (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
4.7
(3.2)
|
5.0
(3.0)
|
4.8
(3.1)
|
Outcome Measures
| Title | Falls |
|---|---|
| Description | Patients were asked daily during hospitalization to self-report any falls |
| Time Frame | 18 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Mobility Group | Control Group |
|---|---|---|
| Arm/Group Description | Participants will receive assistance to walk twice daily, plus a behavioral intervention that 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 | 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. |
| Measure Participants | 50 | 50 |
| Number [participants] |
0
0%
|
2
4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Mobility Group, Control Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <.05 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | Fisher's exact test used as the rate of falling was low. | |
| Title | Life-Space Assessment Score |
|---|---|
| Description | 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. |
| Time Frame | 4-6 weeks after baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Mobility Group | Control Group |
|---|---|---|
| Arm/Group Description | 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 | 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. |
| Measure Participants | 50 | 50 |
| Mean (Standard Deviation) [units on a scale] |
52.5
(29.0)
|
41.6
(21.5)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Mobility Group, Control Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <.05 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Title | Amount of Time Spent Out of Bed as Measured by Wireless Accelerometers |
|---|---|
| Description | 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. |
| Time Frame | During hospital stay |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Mobility Group | Control Group |
|---|---|---|
| Arm/Group Description | 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 | 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. |
| Measure Participants | 28 | 36 |
| Mean (Standard Deviation) [minutes/day] |
43.0
(12.8)
|
44.7
(10.1)
|
Adverse Events
| Time Frame | 18 months | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | 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. | |||
| Arm/Group Title | Mobility Group | Control Group | ||
| Arm/Group Description | 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 | 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. | ||
All Cause Mortality |
||||
| Mobility Group | Control Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Mobility Group | Control Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 8/50 (16%) | 8/50 (16%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| In hospital Falls | 0/50 (0%) | 0 | 2/50 (4%) | 2 |
| Skin and subcutaneous tissue disorders | ||||
| Skin irritation | 0/50 (0%) | 0 | 0/50 (0%) | 0 |
| Surgical and medical procedures | ||||
| Readmission | 4/50 (8%) | 4 | 5/50 (10%) | 5 |
| Death | 2/50 (4%) | 2 | 1/50 (2%) | 1 |
| ICU Transfer | 3/50 (6%) | 3 | 0/50 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Mobility Group | Control Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/50 (10%) | 5/50 (10%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Fall post-hospitalization | 5/50 (10%) | 5 | 5/50 (10%) | 5 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Cynthia J. Brown, MD, MSPH |
|---|---|
| Organization | Birmingham VAMC |
| Phone | 205-933-8101 ext 7300 |
| cynthia.brownd44b2@va.gov |
- E6326-W