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Efficacy and Safety of a Hospital Walking Program for Older Adults

Efficacy and Safety of a Hospital Walking Program for Older Adults

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00715962
Enrollment
100
Registered
2008-07-15
Start date
2010-01-31
Completion date
2011-07-31
Last updated
2016-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Disease

Keywords

Hospitalization, Aged

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.

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.

Interventions

BEHAVIORALBehavioral 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.

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

OTHERFriendly 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.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age greater or equal to 65 years; 2. Admitted to the Birmingham VAMC for a medical condition

Exclusion criteria

1. Delirious based on positive Confusion Assessment Method (CAM); 2. Mini-Cognitive Assessment score indicating dementia; 3. Inability to ambulate 2 weeks prior to admission; 4. Having a medical diagnosis deemed by the primary physician to be a contraindication to ambulation; 5. patient with an imminently terminal illness; and 6. Non-English speaking

Design outcomes

Primary

MeasureTime frameDescription
Falls18 monthsPatients were asked daily during hospitalization to self-report any falls
Amount of Time Spent Out of Bed as Measured by Wireless AccelerometersDuring hospital stayThroughout 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

MeasureTime frameDescription
Life-Space Assessment Score4-6 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.

Countries

United States

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 details

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 by arm

ArmCount
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
50
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.
50
Total100

Baseline characteristics

CharacteristicMobility GroupTotalControl Group
Activities of Daily Living (ADL) 2 Weeks prior to admission7.96 units on a scale
STANDARD_DEVIATION 1.5
8.0 units on a scale
STANDARD_DEVIATION 1.6
8.0 units on a scale
STANDARD_DEVIATION 1.8
ADL on Admission8.8 units on a scale
STANDARD_DEVIATION 2.7
8.9 units on a scale
STANDARD_DEVIATION 2.8
9.1 units on a scale
STANDARD_DEVIATION 2.9
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
50 Participants100 Participants50 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Falls Self-Efficacy15.8 units on a scale
STANDARD_DEVIATION 6.5
15.8 units on a scale
STANDARD_DEVIATION 6.3
15.8 units on a scale
STANDARD_DEVIATION 6.2
Gait speed0.50 meters per second
STANDARD_DEVIATION 0.26
0.51 meters per second
STANDARD_DEVIATION 0.26
0.51 meters per second
STANDARD_DEVIATION 0.26
Geriatric Depression Scale (GDS)4.7 units on a scale
STANDARD_DEVIATION 3.2
4.8 units on a scale
STANDARD_DEVIATION 3.1
5.0 units on a scale
STANDARD_DEVIATION 3
Life-Space Assessment score53.9 units on a scale
STANDARD_DEVIATION 29.4
52.7 units on a scale
STANDARD_DEVIATION 25.5
51.5 units on a scale
STANDARD_DEVIATION 21.1
Mini-Nutritional Assessment score9.4 units on a scale
STANDARD_DEVIATION 2.6
9.2 units on a scale
STANDARD_DEVIATION 2.4
9.0 units on a scale
STANDARD_DEVIATION 2.3
Mobility Knowledge PreTest Score2.4 units on a scale
STANDARD_DEVIATION 1.1
2.5 units on a scale
STANDARD_DEVIATION 1.1
2.6 units on a scale
STANDARD_DEVIATION 1.1
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
11 Participants19 Participants8 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
39 Participants81 Participants42 Participants
Region of Enrollment
United States
50 participants100 participants50 participants
Sex: Female, Male
Female
2 Participants3 Participants1 Participants
Sex: Female, Male
Male
48 Participants97 Participants49 Participants
Short Nutritional Assessment Questionnaire (SNAQ) score13.7 units on a scale
STANDARD_DEVIATION 3.4
13.6 units on a scale
STANDARD_DEVIATION 3.3
13.5 units on a scale
STANDARD_DEVIATION 3.3

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
5 / 505 / 50
serious
Total, serious adverse events
8 / 508 / 50

Outcome results

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.

Time frame: During hospital stay

Population: 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.

ArmMeasureValue (MEAN)Dispersion
Mobility GroupAmount of Time Spent Out of Bed as Measured by Wireless Accelerometers43.0 minutes/dayStandard Deviation 12.8
Control GroupAmount of Time Spent Out of Bed as Measured by Wireless Accelerometers44.7 minutes/dayStandard Deviation 10.1
Primary

Falls

Patients were asked daily during hospitalization to self-report any falls

Time frame: 18 months

ArmMeasureValue (NUMBER)
Mobility GroupFalls0 participants
Control GroupFalls2 participants
p-value: <0.05Fisher Exact
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.

Time frame: 4-6 weeks after baseline

ArmMeasureValue (MEAN)Dispersion
Mobility GroupLife-Space Assessment Score52.5 units on a scaleStandard Deviation 29
Control GroupLife-Space Assessment Score41.6 units on a scaleStandard Deviation 21.5
p-value: <0.05ANCOVA

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026