Acute DiseasePhase 2NCT00715962
Efficacy and Safety of a Hospital Walking Program for Older Adults
A Phase 2 study testing Behavioral intervention, Walking Intervention and Friendly visits in people with Acute Disease, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Acute Disease
- What is being tested?
- Behavioral intervention, Walking Intervention and Friendly visits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jul 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age greater or equal to 65 years;
- Admitted to the Birmingham VAMC for a medical condition
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Medical Center, Birmingham
Birmingham, Alabama, 35233
About this study
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.
Read the 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.
- Conditions
- Acute Disease
- Being tested
- Behavioral intervention, Walking Intervention, Friendly visits
- Keywords
- Hospitalization, Aged
- Medical subject headings
- Acute Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral interventionBehavioural
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 InterventionOther
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
Friendly visitsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Behavioral intervention; Other: Walking Intervention |
| 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. Receives: Other: Friendly visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Falls
Patients were asked daily during hospitalization to self-report any falls
Measured: 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.
Measured: During hospital stay
Secondary outcomes (1)
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.
Measured: 4-6 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2008 (estimated)
- Study startJan 2010
- Primary completionJun 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute DiseaseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Cynthia J. Brown, MD MSPH, Principal investigator, VA Medical Center, Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00715962
- Sponsor's protocol ID
- E6326-W
- Status last verified
- Feb 2016
- First submitted
- 11 Jul 2008
- Last updated
- 24 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 27243899
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Hospital Walking Program for Older Adults
- ClinicalTrials.gov ID
- NCT00715962
- Acronym / sponsor ID
- E6326-W
- Conditions
- Acute Disease
- Keywords
- Hospitalization, Aged
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Jan 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 15 Jul 2008 (estimated)
- Results
- Posted 24 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobility Group | Active comparator | Behavioral: Behavioral intervention, Other: Walking InterventionThe 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. |
| Control Group | Placebo comparator | Other: Friendly visitsThe 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age greater or equal to 65 years;
- Admitted to the Birmingham VAMC for a medical condition
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral interventionUsing 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. | Behavioural | Mobility Group |
| Walking InterventionParticipants 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 | Other | Mobility Group |
| Friendly visitsThe 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. | Other | Control Group |
Primary outcome
Falls
Time frame: 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
Time frame: 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.
1 secondary outcome
Life-Space Assessment Score
Time frame: 4-6 weeks after baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27243899Brown 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.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia J. Brown, MD MSPH principal investigator
VA Medical Center, Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Behavioral intervention, Walking Intervention and Friendly visits in people with Acute Disease, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Falls (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00715962, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2016.