InVEST (Increased Velocity Exercise Specific to Task) in Aging and Mobility Limitations - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Behavioral: InVEST (Increased Velocity Exercise Specific to Task)

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.

Study Type

Interventional

Enrollment

160

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Massachusetts
  - Cambridge, Massachusetts, United States, 02138
    - Spaulding Cambridge Outpatient Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
mobility
Leg power
leg strength
endurance
balance measured at baseline, 8 weeks, and 16 weeks

Secondary Outcome Measures

Outcome Measure
Disability

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Aging (NIA)

Collaborators

Spaulding Rehabilitation Hospital PM&R

Investigators

Principal Investigator: Jonathan F. Bean, MD, MS, Spaulding Cambridge Outpatient Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2001

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria