NCT00158119

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2001

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

July 1, 2001

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

July 26, 2010

Status Verified

July 1, 2010

Enrollment Period

6.2 years

First QC Date

September 7, 2005

Last Update Submit

July 23, 2010

Conditions

Keywords

strength trainingpower trainingexercise trainingfunctional performance tasks

Outcome Measures

Primary Outcomes (5)

  • Leg power

  • leg strength

  • mobility

  • endurance

  • balance measured at baseline, 8 weeks, and 16 weeks

Secondary Outcomes (1)

  • Disability

Interventions

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spaulding Cambridge Outpatient Center

Cambridge, Massachusetts, 02138, United States

Location

Related Publications (10)

  • 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.

    PMID: 11943041BACKGROUND
  • 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.

    PMID: 11982666BACKGROUND
  • 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.

    PMID: 11982665BACKGROUND
  • 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.

    PMID: 15086665BACKGROUND
  • 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.

    PMID: 15221722BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jonathan F. Bean, MD, MS

    Spaulding Cambridge Outpatient Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

July 1, 2001

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

July 26, 2010

Record last verified: 2010-07

Locations