Trial Outcomes & Findings for Efficacy and Safety of a Hospital Walking Program for Older Adults (NCT NCT00715962)
NCT ID: NCT00715962
Last Updated: 2016-03-24
Results Overview
Patients were asked daily during hospitalization to self-report any falls
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
18 months
Results posted on
2016-03-24
Participant Flow
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.
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.
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
44
|
48
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of a Hospital Walking Program for Older Adults
Baseline characteristics by cohort
| Measure |
Mobility Group
n=50 Participants
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
|
Control Group
n=50 Participants
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
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
50 participants
n=7 Participants
|
100 participants
n=5 Participants
|
|
Mobility Knowledge PreTest Score
|
2.4 units on a scale
STANDARD_DEVIATION 1.1 • n=5 Participants
|
2.6 units on a scale
STANDARD_DEVIATION 1.1 • n=7 Participants
|
2.5 units on a scale
STANDARD_DEVIATION 1.1 • n=5 Participants
|
|
Falls Self-Efficacy
|
15.8 units on a scale
STANDARD_DEVIATION 6.5 • n=5 Participants
|
15.8 units on a scale
STANDARD_DEVIATION 6.2 • n=7 Participants
|
15.8 units on a scale
STANDARD_DEVIATION 6.3 • n=5 Participants
|
|
Activities of Daily Living (ADL) 2 Weeks prior to admission
|
7.96 units on a scale
STANDARD_DEVIATION 1.5 • n=5 Participants
|
8.0 units on a scale
STANDARD_DEVIATION 1.8 • n=7 Participants
|
8.0 units on a scale
STANDARD_DEVIATION 1.6 • n=5 Participants
|
|
ADL on Admission
|
8.8 units on a scale
STANDARD_DEVIATION 2.7 • n=5 Participants
|
9.1 units on a scale
STANDARD_DEVIATION 2.9 • n=7 Participants
|
8.9 units on a scale
STANDARD_DEVIATION 2.8 • n=5 Participants
|
|
Life-Space Assessment score
|
53.9 units on a scale
STANDARD_DEVIATION 29.4 • n=5 Participants
|
51.5 units on a scale
STANDARD_DEVIATION 21.1 • n=7 Participants
|
52.7 units on a scale
STANDARD_DEVIATION 25.5 • n=5 Participants
|
|
Mini-Nutritional Assessment score
|
9.4 units on a scale
STANDARD_DEVIATION 2.6 • n=5 Participants
|
9.0 units on a scale
STANDARD_DEVIATION 2.3 • n=7 Participants
|
9.2 units on a scale
STANDARD_DEVIATION 2.4 • n=5 Participants
|
|
Short Nutritional Assessment Questionnaire (SNAQ) score
|
13.7 units on a scale
STANDARD_DEVIATION 3.4 • n=5 Participants
|
13.5 units on a scale
STANDARD_DEVIATION 3.3 • n=7 Participants
|
13.6 units on a scale
STANDARD_DEVIATION 3.3 • n=5 Participants
|
|
Gait speed
|
0.50 meters per second
STANDARD_DEVIATION 0.26 • n=5 Participants
|
0.51 meters per second
STANDARD_DEVIATION 0.26 • n=7 Participants
|
0.51 meters per second
STANDARD_DEVIATION 0.26 • n=5 Participants
|
|
Geriatric Depression Scale (GDS)
|
4.7 units on a scale
STANDARD_DEVIATION 3.2 • n=5 Participants
|
5.0 units on a scale
STANDARD_DEVIATION 3.0 • n=7 Participants
|
4.8 units on a scale
STANDARD_DEVIATION 3.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPatients were asked daily during hospitalization to self-report any falls
Outcome measures
| Measure |
Mobility Group
n=50 Participants
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
|
Control Group
n=50 Participants
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.
|
|---|---|---|
|
Falls
|
0 participants
|
2 participants
|
PRIMARY outcome
Timeframe: During hospital stayPopulation: 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.
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.
Outcome measures
| Measure |
Mobility Group
n=28 Participants
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
|
Control Group
n=36 Participants
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.
|
|---|---|---|
|
Amount of Time Spent Out of Bed as Measured by Wireless Accelerometers
|
43.0 minutes/day
Standard Deviation 12.8
|
44.7 minutes/day
Standard Deviation 10.1
|
SECONDARY outcome
Timeframe: 4-6 weeks after baselineThe 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.
Outcome measures
| Measure |
Mobility Group
n=50 Participants
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
|
Control Group
n=50 Participants
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.
|
|---|---|---|
|
Life-Space Assessment Score
|
52.5 units on a scale
Standard Deviation 29.0
|
41.6 units on a scale
Standard Deviation 21.5
|
Adverse Events
Mobility Group
Serious events: 8 serious events
Other events: 5 other events
Deaths: 0 deaths
Control Group
Serious events: 8 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mobility Group
n=50 participants at risk
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
|
Control Group
n=50 participants at risk
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/50 • 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.
|
0.00%
0/50 • 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.
|
|
Musculoskeletal and connective tissue disorders
In hospital Falls
|
0.00%
0/50 • 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.
|
4.0%
2/50 • Number of events 2 • 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.
|
|
Surgical and medical procedures
Readmission
|
8.0%
4/50 • Number of events 4 • 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.
|
10.0%
5/50 • Number of events 5 • 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.
|
|
Surgical and medical procedures
Death
|
4.0%
2/50 • Number of events 2 • 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.
|
2.0%
1/50 • Number of events 1 • 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.
|
|
Surgical and medical procedures
ICU Transfer
|
6.0%
3/50 • Number of events 3 • 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.
|
0.00%
0/50 • 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.
|
Other adverse events
| Measure |
Mobility Group
n=50 participants at risk
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
|
Control Group
n=50 participants at risk
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Fall post-hospitalization
|
10.0%
5/50 • Number of events 5 • 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.
|
10.0%
5/50 • Number of events 5 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place