Aging Clinical Trial - Effects of Functional Incidental Training in VA

Status Completed

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.

Clinical Trial 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. ;

Study Design

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

Related Conditions & MeSH terms

Aging

Clinical Trial Details

NCT number	NCT00013507
Study type	Interventional
Source	VA Office of Research and Development
Contact
Status	Completed
Phase	Phase 2
Start date	January 1999
Completion date	December 2002

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effects of Functional Incidental Training in VA NHCU Residents

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms