Efficacy and Safety of a Hospital Walking Program for Older Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00715962
First received: July 11, 2008
Last updated: June 19, 2012
Last verified: June 2012
  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
Hospitalization
Behavioral: Behavioral encouragement of out of bed activity
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
Primary Purpose: Treatment
Official Title: Efficacy and Safety of a Hospital Walking Program for Older Adults

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Amount of time spent out of bed as measured by wireless accelerometers [ Time Frame: During hospital stay ] [ Designated as safety issue: No ]

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
Experimental: Arm 1
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: 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.
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
Arm 2
The control group will receive twice daily friendly visits. 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
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-Gonitive 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
Investigators
Principal Investigator: Cynthia J. Brown, MD MSPH VA Medical Center, Birmingham
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00715962     History of Changes
Other Study ID Numbers: E6326-W
Study First Received: July 11, 2008
Last Updated: June 19, 2012
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Hospitalization
Aged

ClinicalTrials.gov processed this record on July 31, 2014