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Home-based Exercise Via a Telecommunications System

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ClinicalTrials.gov Identifier: NCT00248781
Recruitment Status : Completed
First Posted : November 4, 2005
Results First Posted : January 10, 2014
Last Update Posted : January 10, 2014
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Functional Limitation Device: Telecommunications system Device: attention control Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Home-based Exercise Via a Telecommunications System
Study Start Date : September 2003
Actual Primary Completion Date : April 2009
Actual Study Completion Date : November 2009

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1
exercise
 Device: Telecommunications system
Arm 2
health education
 Device: attention control
health education


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00248781


Locations
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United States, Massachusetts
VA Boston Health Care System
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
US Department of Veterans Affairs
Investigators
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Principal Investigator: David William Sparrow, DSc VA Boston Health Care System
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: US Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00248781    
Other Study ID Numbers: E2777-R
First Posted: November 4, 2005    Key Record Dates
Results First Posted: January 10, 2014
Last Update Posted: January 10, 2014
Last Verified: December 2013
Keywords provided by VA Office of Research and Development ( US Department of Veterans Affairs ):
Activities of daily living
Aging
Exercise
Weight lifting