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Clinical Trials/NCT00248781
NCT00248781
Completed
Phase 3

Home-based Exercise Via a Telecommunications System

US Department of Veterans Affairs1 site in 1 country103 target enrollmentSeptember 2003

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Functional Limitation
Sponsor
US Department of Veterans Affairs
Enrollment
103
Locations
1
Primary Endpoint
Knee Extension Strength
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

This study is investigating the effects of a home-based resistance exercise program, administered via an interactive telecommunications system, in functionally limited older veterans.

Detailed Description

Inactivity and a sedentary lifestyle have been shown to accelerate and exaggerate the age-related decline in muscle strength. In this context, a rapid decline in strength among older adults has been linked to physical frailty, falls, functional decline, impaired mobility, and nursing home placement. Substantial evidence now suggests that habitual physical activity is associated with the maintenance of muscle strength and physical function well into the 8th and 9th decades of life. We propose to investigate the effects of a home-based resistance exercise program, administered via an interactive telecommunications system without the participation of health professionals, in functionally limited older veterans. Subjects will be randomized to either the automated exercise group or an attention placebo control group. The exercise group will undergo resistance training at home three times a week for 6 months, guided by the telecommunications system, followed by a 6-month maintenance phase of less frequent interaction with the system. Outcome measurements will include muscle strength and physical performance related to daily activities at 3, 6, and 12 months to determine the efficacy of the intervention and the time course and durability of the effect. The control group will also interact with the telecommunications system once a week for the whole year, but no exercise will be prescribed. If this home-based, automated, interactive exercise program is effective, it will provide a low-cost easily disseminated approach to improving the strength and functional status of older veterans

Registry
clinicaltrials.gov
Start Date
September 2003
End Date
November 2009
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age 65 years
  • Ability to use a telephone without assistance

Exclusion Criteria

  • Angina pectoris
  • Myocardial infarction
  • Ventricular dysrhythmia currently receiving therapy
  • Systolic blood pressure 165 mm Hg or diastolic blood pressure 100 mm Hg

Outcomes

Primary Outcomes

Knee Extension Strength

Time Frame: 6 months

The peak force measured during the bilateral knee extension exercise against the highest level of a hydraulic resistance system

Knee Flexion Strength

Time Frame: 6 months

The peak force measured during the bilateral knee flexion exercise against the highest level of a hydraulic resistance system

Single Leg Stance With Eyes Open

Time Frame: 6 months

Length of time standing on one leg without moving the support foot, touching the floor or support leg with suspended foot, or requiring assistance.

Six-minute Walk

Time Frame: 6 months

Total distance walked during 6 minutes. Subjects were instructed to walk up and down a 100-foot level hallway as far as they could in 6 minutes.

Tandem Stance

Time Frame: 6 months

Length of time standing with the heel of one foot touching the toe of the other foot keeping the feet in a straight line.

Secondary Outcomes

  • Knee Extension Strength (Durability)(12 months)
  • Knee Flexion Strength (Durability)(12 months)
  • Six-minute Walk (Durability)(12 months)
  • Tandem Stance (Durability)(12 months)
  • Single Leg Stance With Eyes Open (Durability)(12 months)

Study Sites (1)

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