NCT00038155

Brief Summary

Hospitalization for an acute medical condition often results in functional decline in older adults. This loss of function often is not reversed after hospital discharge. Our general hypothesis is that patients will benefit from rehabilitation that occurs simultaneously with the medical management of acute conditions and when linked with a home exercise program that can be implemented after discharge from the hospital. This approach differs from the traditional approach of addressing rehabilitation needs after acute conditions have resolved and providing rehabilitation services for selected patients in institutional settings, such as subacute units or nursing homes. The feasibility of the program will be assessed by documenting the participation of subjects during the inpatient phase and adherence of subjects with the home-based program. Fifty subjects will be recruited from individuals who are 60 years of age or older who have been admitted to the Birmingham Veterans Affairs Medical Center (VAMC) for treatment of an acute medical condition. Subjects will be either unable to ambulate, require assistance for ambulation, or be unable to ambulate a functional distance (150 feet) at a functional velocity (30m/min). Subjects will be randomly assigned to a physical rehabilitation group (PR) or to a control group (CON). During hospitalization, subjects in the PR group daily will have one 45-minute morning rehabilitation session and one 30-minute evening rehabilitation session. Both sessions will include ambulation and transfer training. The longer morning session will also include resistance exercise. Subjects in the CON group will have medial care as it is currently provided. During the six months after discharge, subjects in the PR group will perform a home-based exercise program consisting of ambulation and resistance exercises. The program will be monitored and progressed by an exercise physiologist who will visit subjects weekly for the first month after discharge, every other week for the second and third months after discharge, and monthly in the fourth, fifth, and six months after discharge. This study is designed to test the feasibility and effectiveness of a practical and potentially cost-effective rehabilitation program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2002

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 30, 2002

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

September 24, 2010

Status Verified

September 1, 2010

Enrollment Period

3.3 years

First QC Date

May 29, 2002

Last Update Submit

September 22, 2010

Conditions

Keywords

AmbulationDifficulties in ambulationGeriatricRehabilitation

Outcome Measures

Primary Outcomes (1)

  • feasibility of recruitment and intervention

    discharge and 6 months post discharge

Study Arms (1)

1

OTHER
Procedure: Ambulation training

Interventions

Recruitment of eligible subjects, ambulatory and resistance training in hospital and post-discharge

1

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Older patients with ambulation difficulty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center, Birmingham

Birmingham, Alabama, 35233, United States

Location

Study Officials

  • Richard Allman, MD

    VA Medical Center, Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 29, 2002

First Posted

May 30, 2002

Study Start

May 1, 2002

Primary Completion

September 1, 2005

Study Completion

September 1, 2005

Last Updated

September 24, 2010

Record last verified: 2010-09

Locations