Home-based Exercise Via a Telecommunications System
December 10, 2013 updated by: US Department of Veterans Affairs
This study is investigating the effects of a home-based resistance exercise program, administered via an interactive telecommunications system, in functionally limited older veterans.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
103
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02130
- VA Boston Health Care system
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm 1
exercise
|
|
|
Other: Arm 2
health education
|
health education
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
6 months
|
|
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
|
6 months
|
|
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.
|
6 months
|
|
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.
|
6 months
|
|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knee Extension Strength (Durability)
Time Frame: 12 months
|
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)
Time Frame: 12 months
|
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)
Time Frame: 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.
|
12 months
|
|
Tandem Stance (Durability)
Time Frame: 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.
|
12 months
|
|
Six-minute Walk (Durability)
Time Frame: 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.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: David William Sparrow, DSc, VA Boston Health Care system
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2003
Primary Completion (Actual)
April 1, 2009
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
November 2, 2005
First Submitted That Met QC Criteria
November 3, 2005
First Posted (Estimate)
November 4, 2005
Study Record Updates
Last Update Posted (Estimate)
January 10, 2014
Last Update Submitted That Met QC Criteria
December 10, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- E2777-R
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.