Home-based Exercise Via a Telecommunications System

Study 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

Official Title
-----------------
Home-based Exercise Via a Telecommunications System

Conditions
-----------------
Functional Limitation

Intervention / Treatment
-----------------
* Device: Telecommunications system
* Device: attention control


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>exercise | Device: Telecommunications system<br> <br> |
| Other: Arm 2<br>health education | Device: attention control<br>* health education<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Extension Strength | The peak force measured during the bilateral knee extension exercise against the highest level of a hydraulic resistance system | 6 months | 
| Knee Flexion Strength | The peak force measured during the bilateral knee flexion exercise against the highest level of a hydraulic resistance system | 6 months | 
| Single Leg Stance With Eyes Open | Length of time standing on one leg without moving the support foot, touching the floor or support leg with suspended foot, or requiring assistance. | 6 months | 
| Tandem Stance | Length of time standing with the heel of one foot touching the toe of the other foot keeping the feet in a straight line. | 6 months | 
| Six-minute Walk | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Extension Strength (Durability) | The peak force measured during the bilateral knee extension exercise against the highest level of a hydraulic resistance system | 12 months | 
| Knee Flexion Strength (Durability) | The peak force measured during the bilateral knee flexion exercise against the highest level of a hydraulic resistance system | 12 months | 
| Single Leg Stance With Eyes Open (Durability) | Length of time standing on one leg without moving the support foot, touching the floor or support leg with suspended foot, or requiring assistance. | 12 months | 
| Tandem Stance (Durability) | Length of time standing with the heel of one foot touching the toe of the other foot keeping the feet in a straight line. | 12 months | 
| Six-minute Walk (Durability) | 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. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Activities of daily living, Aging, Exercise, Weight lifting