Functional LimitationPhase 3NCT00248781
Home-based Exercise Via a Telecommunications System
A Phase 3 study testing Telecommunications system in people with Functional Limitation, run by US Department of Veterans Affairs at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Functional Limitation
- What is being tested?
- Telecommunications system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Nov 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 65 years
- Ability to use a telephone without assistance
Who cannot join
- Angina pectoris
- Myocardial infarction
- Ventricular dysrhythmia currently receiving therapy
- Systolic blood pressure 165 mm Hg or diastolic blood pressure 100 mm Hg
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Boston Health Care System
Boston, Massachusetts, 02130
About this study
This study is investigating the effects of a home-based resistance exercise program, administered via an interactive telecommunications system, in functionally limited older veterans.
Read the 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
- Conditions
- Functional Limitation
- Being tested
- Telecommunications system, attention control
- Keywords
- Activities of daily living, Aging, Exercise, Weight lifting
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telecommunications systemDevice
attention controlDevice
health education
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | exercise Receives: Device: Telecommunications system |
| Arm 2 | Other | health education Receives: Device: attention control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Extension Strength
The peak force measured during the bilateral knee extension exercise against the highest level of a hydraulic resistance system
Measured: 6 months
Knee Flexion Strength
The peak force measured during the bilateral knee flexion exercise against the highest level of a hydraulic resistance system
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (5)
Knee Extension Strength (Durability)
The peak force measured during the bilateral knee extension exercise against the highest level of a hydraulic resistance system
Measured: 12 months
Knee Flexion Strength (Durability)
The peak force measured during the bilateral knee flexion exercise against the highest level of a hydraulic resistance system
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2005 (estimated)
- Study startSep 2003
- Primary completionApr 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Functional LimitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- David William Sparrow, DSc, Principal investigator, VA Boston Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00248781
- Sponsor's protocol ID
- E2777-R
- Status last verified
- Dec 2013
- First submitted
- 2 Nov 2005
- Last updated
- 10 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Exercise Via a Telecommunications System
- ClinicalTrials.gov ID
- NCT00248781
- Acronym / sponsor ID
- E2777-R
- Conditions
- Functional Limitation
- Keywords
- Activities of daily living, Aging, Exercise, Weight lifting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Sep 2003
- Primary completion
- Apr 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 4 Nov 2005 (estimated)
- Results
- Posted 10 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is investigating the effects of a home-based resistance exercise program, administered via an interactive telecommunications system, in functionally limited older veterans.
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Device: Telecommunications systemexercise |
| Arm 2 | Other | Device: attention controlhealth education |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age 65 years
- Ability to use a telephone without assistance
Key exclusion criteria (4 listed)
- Angina pectoris
- Myocardial infarction
- Ventricular dysrhythmia currently receiving therapy
- Systolic blood pressure 165 mm Hg or diastolic blood pressure 100 mm Hg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telecommunications system | Device | Arm 1 |
| attention controlhealth education | Device | Arm 2 |
Primary outcome
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
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
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.
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.
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.
5 secondary outcomes
Knee Extension Strength (Durability)
Time frame: 12 months
Knee Flexion Strength (Durability)
Time frame: 12 months
Single Leg Stance With Eyes Open (Durability)
Time frame: 12 months
Tandem Stance (Durability)
Time frame: 12 months
Six-minute Walk (Durability)
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David William Sparrow, DSc principal investigator
VA Boston Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Telecommunications system in people with Functional Limitation, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Extension Strength (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2014; AzTrials last refreshed its copy on 27 Oct 2026.