Home-based Exercise Via a Telecommunications System

Functional Limitation Clinical Trial

Official title:

Home-based Exercise Via a Telecommunications System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00248781
• Other study ID #: E2777-R
• Status: Completed
• Phase: Phase 3
• First received: November 2, 2005
• Last updated: December 10, 2013
• Start date: September 2003
• Est. completion date: November 2009

Study information

• Verified date: December 2013
• 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 study is investigating the effects of a home-based resistance exercise program, administered via an interactive telecommunications system, in functionally limited older veterans.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: November 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Functional Limitation

Intervention

Device:
• Telecommunications system

• attention control
health education

Locations

Country	Name	City	State
United States	VA Boston Health Care System	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Extension Strength	The peak force measured during the bilateral knee extension exercise against the highest level of a hydraulic resistance system	6 months	No
Primary	Knee Flexion Strength	The peak force measured during the bilateral knee flexion exercise against the highest level of a hydraulic resistance system	6 months	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No