Home-based Exercise Via a Telecommunications System

Phase 3

Completed

• Conditions: Functional Limitation
• Interventions: Device: attention control; Device: Telecommunications system

• Registration Number: NCT00248781
• Lead Sponsor: US Department of Veterans Affairs

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2005-11-02
• Study First Submitted QC: 2005-11-03
• Study First Posted: 2005-11-04
• Primary Completion: 2009-04
• Study Completion: 2009-11
• Results First Submitted: 2013-09-24
• Status Verified: 2013-12
• Results First Submitted QC: 2013-12-10
• Last Update Submitted: 2013-12-10
• Results First Posted: 2014-01-10
• Last Update Posted: 2014-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	attention control	health education
Arm 1	Telecommunications system	exercise

Primary Outcome Measures

Name	Time	Method
Knee Extension Strength	6 months	The peak force measured during the bilateral knee extension exercise against the highest level of a hydraulic resistance system
Knee Flexion Strength	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	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	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	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 Outcome Measures

Name	Time	Method
Knee Extension Strength (Durability)	12 months	The peak force measured during the bilateral knee extension exercise against the highest level of a hydraulic resistance system
Knee Flexion Strength (Durability)	12 months	The peak force measured during the bilateral knee flexion exercise against the highest level of a hydraulic resistance system
Six-minute Walk (Durability)	12 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 (Durability)	12 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.
Single Leg Stance With Eyes Open (Durability)	12 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.

Trial Locations

Locations (1)

VA Boston Health Care System; 🇺🇸 Boston, Massachusetts, United States