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Mobility LimitationsPhase 3NCT00158119

A Comparison of Weighted Vest Exercise and Strength Training

A Phase 3 study testing InVEST (Increased Velocity Exercise Specific to Task) in people with Mobility Limitations and Aging, run by National Institute on Aging (NIA) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate two types of exercise therapy designed to improve muscle power and mobility: weighted vest exercise vs. progressive resistance training. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Mobility Limitations, Aging
What is being tested?
InVEST (Increased Velocity Exercise Specific to Task)
How many people
160 participants
Where
1 siteUnited States
Study dates
Jul 2001to Sep 2007
Phase
Phase 3
Are there results?
None posted in the registry

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
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Community dwelling men and women aged 65 or older
  • Ability to provide informed consent
  • Impairment in physical performance, based on a score between 4 and 10 inclusive on the SPPB (Short Physical Performance Battery), which evaluates standing balance, walking speed, and chair-rise time
  • Score of 24 or greater on the Folstein mini-mental status exam
  • Exhibit independent stair-climbing ability

Who cannot join

  • Unstable acute or chronic disease
  • Neuromusculoskeletal impairment interfering with independent stair climbing
  • Abdominal aortic aneurysm
  • Exertional angina
  • History of ventricular arrhythmia
  • Inguinal or abdominal hernia
  • Symptomatic valvular heart disease

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Spaulding Cambridge Outpatient Center

    Cambridge, Massachusetts, 02138

Other trials in United States

About this study

Official title: Ameliorating Disability Through Power Training

The purpose of this study is to evaluate two types of exercise therapy designed to improve muscle power and mobility: weighted vest exercise vs. progressive resistance training.

Read the detailed description

Muscle power, a separate physical attribute from strength, is an important determinate of physical functioning in the elderly, for example in avoiding impending falls, rising from a chair, and climbing stairs. Muscle power, which declines with aging at a different rate than strength, has been shown in previous studies to improve through power training utilizing specially designed exercise equipment. However, weighted vest exercise could provide an acceptable, low cost, readily accessible alternative.

The hypotheses being tested in this study are: 1) weighted vest exercise will improve lower extremity power when compared to age matched controls in a standardized progressive resistance training program; 2) improvements in lower extremity power enhance functional performance as shown by improved gait velocity, stair climbing, and chair rise time; and 3) weighted vest exercise in impaired older adults will improve self-reported function and disability.

One hundred sixty-four men and women ages 65 and older, with some physical limitation but able to climb stairs independently, will be randomized to one of two 16-week exercise programs. The intervention group will participate in a weighted vest exercise protocol, consisting of chair-based and stair-climbing exercise, while the control group will participate in a standardized progressive resistance training program. Participants in both programs will meet three times per week for 30-60 minutes per session, for a total of 16 weeks, at a research exercise gym, and will be under the direct supervision of research staff.

Being tested
InVEST (Increased Velocity Exercise Specific to Task)
Keywords
strength training, power training, exercise training, functional performance tasks
Medical subject headings
Mobility Limitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InVEST (Increased Velocity Exercise Specific to Task)Behavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Leg power

  2. leg strength

  3. mobility

  4. endurance

  5. balance measured at baseline, 8 weeks, and 16 weeks

Secondary outcomes (1)

  1. Disability

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2005 (estimated)
  2. Study startJul 2001
  3. Primary completionSep 2007
  4. Study completionSep 2007

Resources

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
160 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00158119
Sponsor's protocol ID
AG0037
Other IDs
K23AG019663-01
Status last verified
Jul 2010
First submitted
7 Sep 2005
Last updated
26 Jul 2010
Results posted
No

Publications

  • Bean JF, Kiely DK, Herman S, Leveille SG, Mizer K, Frontera WR, Fielding RA. The relationship between leg power and physical performance in mobility-limited older people. J Am Geriatr Soc. 2002 Mar;50(3):461-7. doi: 10.1046/j.1532-5415.2002.50111.x.

    PubMed 11943041

  • Bean J, Herman S, Kiely DK, Callahan D, Mizer K, Frontera WR, Fielding RA. Weighted stair climbing in mobility-limited older people: a pilot study. J Am Geriatr Soc. 2002 Apr;50(4):663-70. doi: 10.1046/j.1532-5415.2002.50160.x.

    PubMed 11982666

  • Fielding RA, LeBrasseur NK, Cuoco A, Bean J, Mizer K, Fiatarone Singh MA. High-velocity resistance training increases skeletal muscle peak power in older women. J Am Geriatr Soc. 2002 Apr;50(4):655-62. doi: 10.1046/j.1532-5415.2002.50159.x.

    PubMed 11982665

  • Bean JF, Herman S, Kiely DK, Frey IC, Leveille SG, Fielding RA, Frontera WR. Increased Velocity Exercise Specific to Task (InVEST) training: a pilot study exploring effects on leg power, balance, and mobility in community-dwelling older women. J Am Geriatr Soc. 2004 May;52(5):799-804. doi: 10.1111/j.1532-5415.2004.52222.x.

    PubMed 15086665

  • Bean JF, Vora A, Frontera WR. Benefits of exercise for community-dwelling older adults. Arch Phys Med Rehabil. 2004 Jul;85(7 Suppl 3):S31-42; quiz S43-4. doi: 10.1016/j.apmr.2004.03.010.

    PubMed 15221722

  • Li X, Forman DE, Kiely DK, LaRose S, Hirschberg R, Frontera WR, Bean JF. Validity of an exercise test based on habitual gait speed in mobility-limited older adults. Arch Phys Med Rehabil. 2012 Feb;93(2):344-50. doi: 10.1016/j.apmr.2011.08.032.

    PubMed 22289248

  • Suri P, Kiely DK, Leveille SG, Frontera WR, Bean JF. Increased trunk extension endurance is associated with meaningful improvement in balance among older adults with mobility problems. Arch Phys Med Rehabil. 2011 Jul;92(7):1038-43. doi: 10.1016/j.apmr.2010.12.044. Epub 2011 Jun 2.

    PubMed 21636073

  • Bean JF, Kiely DK, LaRose S, Goldstein R, Frontera WR, Leveille SG. Are changes in leg power responsible for clinically meaningful improvements in mobility in older adults? J Am Geriatr Soc. 2010 Dec;58(12):2363-8. doi: 10.1111/j.1532-5415.2010.03155.x.

    PubMed 21143443

  • Suri P, Kiely DK, Leveille SG, Frontera WR, Bean JF. Trunk muscle attributes are associated with balance and mobility in older adults: a pilot study. PM R. 2009 Oct;1(10):916-24. doi: 10.1016/j.pmrj.2009.09.009.

    PubMed 19854420

  • Bean JF, Kiely DK, LaRose S, O'Neill E, Goldstein R, Frontera WR. Increased velocity exercise specific to task training versus the National Institute on Aging's strength training program: changes in limb power and mobility. J Gerontol A Biol Sci Med Sci. 2009 Sep;64(9):983-91. doi: 10.1093/gerona/glp056. Epub 2009 May 4.

    PubMed 19414509

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing InVEST (Increased Velocity Exercise Specific to Task) in people with Mobility Limitations and Aging, run by National Institute on Aging (NIA) 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 5 inclusion and 7 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 26 Jul 2010. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Leg power. 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?

On the ClinicalTrials.gov record for NCT00158119, which also lists 10 linked publications.

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 26 Jul 2010.

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