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NCT00013507 Clinical Trial

Effects of Functional Incidental Training in VA NHCU Residents

Aging Clinical Trial

Official title:
Effects of Functional Incidental Training in VA NHCU Residents

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00013507
Other study ID # E2226R
Secondary ID
Status Completed
Phase Phase 2
First received March 14, 2001
Last updated January 20, 2009
Start date January 1999
Est. completion date December 2002

Study information
Verified date January 2001
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

This research on Functional Incidental Training ( FIT) primarily involves women residing in community nursing homes. It is an individualized rehabilitative protocol intended to improve mobility, endurance, strength and continence in frail, older, functionally impaired and disabled veterans.

Objectives of the project are as follows:

1) Test the effects of FIT on transfer ability, continence, ambulation/mobility, balance and fall risk, strength, and endurance; 2) Determine the characteristics of NHCU residents who respond to FIT; 3)Identify the most sensitive outcome measures related to FIT; and 4) Determine the labor costs of FIT relative to usual care.

Description:

This research on Functional Incidental Training ( FIT) primarily involves women in community nursing homes.

Objectives:

1. test the effects of FIT on functions such as transfer ability, continence, ambulation/mobility,balance and fall risk, strength, and endurance; 2. determine the characteristics of NHCU residents who respond to FIT; 3. identify the most sensitive outcome measures related to FIT; and 4. determine the labor costs of FIT relative to usual care.

. The intervention is an individualized rehabilitative protocol intended to improve mobility, endurance, strength and continence in frail, older, functionally impaired and disabled veterans in VA nursing home care units(NHCUs).The design is a multi-site cross-over design, to be carried out in five NHCUs (Atlanta, Durham, Salisbury, Augusta, Tuscaloosa) over about eight months in each site. About 24 residents will be recruited in each NHCU: 12 each will be randomized to initial intervention and control for 8 wks and evaluated; the controls will then receive the intervention and vice versa for another 8 wks with another evaluation. Patients are seen 4x a day for FIT activities, including walking/using wheel chair, prompted toileting, strengthening exercises. Outcome measures will be made in a blinded manner by Project Manager.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date December 2002
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Functionally impaired elderly

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Procedure:
• Falls

Locations
Country Name City State
United States VAMC, Decatur Decatur Georgia

Sponsors (1)
Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

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