Efficacy and Safety of a Hospital Walking Program for Older Adults

NCT00715962 | Completed Phase 2 Results DMC

• 1 other identifier: E6326-W
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Disease

Keywords

Hospitalization; Aged

Outcome Measures

Primary Outcomes (2)

• Falls

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

  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.

  During hospital stay

Secondary Outcomes (1)

• Life-Space Assessment Score

  4-6 weeks after baseline

Study Arms (2)

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.

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.

Other: Friendly visits

Interventions

Behavioral intervention BEHAVIORAL

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.

Mobility Group

Walking Intervention OTHER

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

Mobility Group

Friendly visits OTHER

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.

Control Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Medical Center, Birmingham

Birmingham, Alabama, 35233, United States

Location

Related Publications (1)

• 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.

  PMID: 27243899 DERIVED

MeSH Terms

Conditions

Acute Disease

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

Study may not be generalizable as subjects mostly male and not demented or delirious. Study sample is small and needs to be replicated in a larger cohort.

Results Point of Contact

• Title: Cynthia J. Brown, MD, MSPH
• Organization: Birmingham VAMC

cynthia.brownd44b2@va.gov

205-933-8101

Study Officials

• Cynthia J. Brown, MD MSPH

  VA Medical Center, Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2008
• First Posted: July 15, 2008
• Study Start: January 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2011
• Last Updated: March 24, 2016
• Results First Posted: March 24, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)