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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00158119
Other study ID # AG0037
Secondary ID K23AG019663-01
Status Completed
Phase Phase 3
First received September 7, 2005
Last updated July 23, 2010
Start date July 2001
Est. completion date September 2007

Study information

Verified date July 2010
Source National Institute on Aging (NIA)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date September 2007
Est. primary completion date September 2007
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
InVEST (Increased Velocity Exercise Specific to Task)


Locations

Country Name City State
United States Spaulding Cambridge Outpatient Center Cambridge Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
National Institute on Aging (NIA) Spaulding Rehabilitation Hospital PM&R

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Leg power
Primary leg strength
Primary mobility
Primary endurance
Primary balance measured at baseline, 8 weeks, and 16 weeks
Secondary Disability
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