Home-based Exercise Via a Telecommunications System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00248781
First received: November 2, 2005
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Functional Limitation
Device: Telecommunications system
Device: attention control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Home-based Exercise Via a Telecommunications System

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Knee Extension Strength [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Length of time standing on one leg without moving the support foot, touching the floor or support leg with suspended foot, or requiring assistance.

  • Tandem Stance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Length of time standing with the heel of one foot touching the toe of the other foot keeping the feet in a straight line.

  • Six-minute Walk [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Knee Extension Strength (Durability) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The peak force measured during the bilateral knee extension exercise against the highest level of a hydraulic resistance system

  • Knee Flexion Strength (Durability) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 (Durability) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Length of time standing on one leg without moving the support foot, touching the floor or support leg with suspended foot, or requiring assistance.

  • Tandem Stance (Durability) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Length of time standing with the heel of one foot touching the toe of the other foot keeping the feet in a straight line.

  • Six-minute Walk (Durability) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 103
Study Start Date: September 2003
Study Completion Date: November 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
exercise
Device: Telecommunications system
Arm 2
health education
Device: attention control
health education

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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00248781

Locations
United States, Massachusetts
VA Boston Health Care System
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
Investigators
Principal Investigator: David William Sparrow, DSc VA Boston Health Care System
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00248781     History of Changes
Other Study ID Numbers: E2777-R
Study First Received: November 2, 2005
Results First Received: September 24, 2013
Last Updated: December 10, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Activities of daily living
Aging
Exercise
Weight lifting

ClinicalTrials.gov processed this record on April 16, 2014