Efficacy and Safety of a Hospital Walking Program for Older Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00715962
First received: July 11, 2008
Last updated: February 23, 2016
Last verified: February 2016
  Purpose
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 Intervention Phase
Acute Disease
Behavioral: Behavioral intervention
Other: Walking Intervention
Other: Friendly visits
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of a Hospital Walking Program for Older Adults

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Falls [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 4-6 weeks after baseline ] [ Designated as safety issue: No ]
    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.


Enrollment: 100
Study Start Date: January 2010
Study Completion Date: July 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00715962

Locations
United States, Alabama
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
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00715962     History of Changes
Other Study ID Numbers: E6326-W 
Study First Received: July 11, 2008
Results First Received: January 22, 2016
Last Updated: February 23, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: 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.

Keywords provided by VA Office of Research and Development:
Hospitalization
Aged

Additional relevant MeSH terms:
Acute Disease
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2016