NCT00248781

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2003

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 4, 2005

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

January 10, 2014

Completed
Last Updated

January 10, 2014

Status Verified

December 1, 2013

Enrollment Period

5.6 years

First QC Date

November 2, 2005

Results QC Date

September 24, 2013

Last Update Submit

December 10, 2013

Conditions

Functional Limitation

Keywords

Activities of daily livingAgingExerciseWeight lifting

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (5)

  • Knee Extension Strength (Durability)

    12 months

  • Knee Flexion Strength (Durability)

    12 months

  • Single Leg Stance With Eyes Open (Durability)

    12 months

  • Tandem Stance (Durability)

    12 months

  • Six-minute Walk (Durability)

    12 months

Study Arms (2)

Arm 1

EXPERIMENTAL

exercise

Device: Telecommunications system

Arm 2

OTHER

health education

Device: attention control

Interventions

Telecommunications systemDEVICE
Arm 1
attention controlDEVICE

health education

Arm 2

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age 65 years
  • Ability to use a telephone without assistance

You may not qualify if:

  • Angina pectoris
  • Myocardial infarction
  • Ventricular dysrhythmia currently receiving therapy
  • Systolic blood pressure 165 mm Hg or diastolic blood pressure 100 mm Hg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Boston Health Care System

Boston, Massachusetts, 02130, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Dr. David Sparrow
Organization
VA Boston Healthcare System
david.sparrow@va.gov
857-364-6407

Study Officials

  • David William Sparrow, DSc

    VA Boston Health Care System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2005

First Posted

November 4, 2005

Study Start

September 1, 2003

Primary Completion

April 1, 2009

Study Completion

November 1, 2009

Last Updated

January 10, 2014

Results First Posted

January 10, 2014

Record last verified: 2013-12

Locations

US(1)