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Exercise for Elderly Peripheral Revascularized Patients

NCT ID: NCT00667290

Last Updated: 2008-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-07-31

Study Completion Date

2007-06-30

Brief Summary

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The purpose of this study is (1) to determine whether a 3-month exercise rehabilitation program will improve claudication distances, free-living daily physical activity, and health-related quality of life of older, revascularized patients with peripheral arterial disease, and (2) to determine whether the primary mechanisms by which exercise rehabilitation affects the above functional outcomes are through alterations in walking efficiency, peripheral circulation, and cardiopulmonary function.

Detailed Description

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Peripheral arterial disease (PAD) patients with critical limb-threatening ischemia have improved peripheral circulation following infrainguinal revascularization. Despite this hemodynamic benefit, little change in functional status occurs, and many patients have residual ambulatory dysfunction. The lack of functional improvement in revascularized patients may be due to extreme physical deconditioning secondary to their pre-existing critical limb-threatening ischemia. Therefore, we hypothesize that a program of aerobic exercise training is necessary to optimize ambulation, free-living daily physical activity, and health-related quality of life through the mechanisms of improved walking economy, peripheral circulation, and cardiopulmonary function.

This is a prospective, randomized controlled clinical trial comparing an exercise group undergoing a program of graded treadmill walking, and a non-exercise control group. Eighty PAD patients will be randomized into either the exercise group (N = 40) or the non-exercise control group (N = 40) following successful lower extremity arterial bypass or angioplasty. The 3-month exercise program will consist of graded treadmill walking 3 times per week with progressive increments in exercise duration from 15 to 40 minutes, and progressive increments in exercise intensity from 50 to 80% of exercise capacity.

Conditions

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Peripheral Artery Disease Intermittent Claudication

Keywords

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functional ability gait musculoskeletal disorder therapy peripheral blood vessel disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Study Groups

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1

Group Type EXPERIMENTAL

Treadmill exercise

Intervention Type BEHAVIORAL

Graded treadmill walking 3 times per week for 3 months

2

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Treadmill exercise

Graded treadmill walking 3 times per week for 3 months

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* lower extremity arterial bypass at least 3 months prior to screening
* infrainguinal percutaneous transluminal angioplasty (PTLA) at least 2 weeks prior to screening

Exclusion Criteria

* persistent rest pain due to (peripheral artery disease (PAD) (Fontaine Stage III for PAD),
* persistent tissue loss due to PAOD (Fontaine Stage IV for PAD),
* medical conditions that are contraindicative for exercise according to the American College of Sports Medicine (e.g., acute myocardial infarction, unstable angina, etc.)
* cognitive dysfunction (mini-mental state examination score of less than 24)
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role lead

Responsible Party

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University of Oklahoma Health Sciences Center

Principal Investigators

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Andrew W. Gardner, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

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General Clinical Research Center, University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

References

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Gardner AW, Poehlman ET. Exercise rehabilitation programs for the treatment of claudication pain. A meta-analysis. JAMA. 1995 Sep 27;274(12):975-80.

Reference Type BACKGROUND
PMID: 7674529 (View on PubMed)

Gardner AW, Katzel LI, Sorkin JD, Bradham DD, Hochberg MC, Flinn WR, Goldberg AP. Exercise rehabilitation improves functional outcomes and peripheral circulation in patients with intermittent claudication: a randomized controlled trial. J Am Geriatr Soc. 2001 Jun;49(6):755-62. doi: 10.1046/j.1532-5415.2001.49152.x.

Reference Type BACKGROUND
PMID: 11454114 (View on PubMed)

Gardner AW, Katzel LI, Sorkin JD, Goldberg AP. Effects of long-term exercise rehabilitation on claudication distances in patients with peripheral arterial disease: a randomized controlled trial. J Cardiopulm Rehabil. 2002 May-Jun;22(3):192-8. doi: 10.1097/00008483-200205000-00011.

Reference Type BACKGROUND
PMID: 12042688 (View on PubMed)

Gardner AW, Killewich LA, Montgomery PS, Katzel LI. Response to exercise rehabilitation in smoking and nonsmoking patients with intermittent claudication. J Vasc Surg. 2004 Mar;39(3):531-8. doi: 10.1016/j.jvs.2003.08.037.

Reference Type BACKGROUND
PMID: 14981444 (View on PubMed)

Gardner AW, Montgomery PS, Flinn WR, Katzel LI. The effect of exercise intensity on the response to exercise rehabilitation in patients with intermittent claudication. J Vasc Surg. 2005 Oct;42(4):702-9. doi: 10.1016/j.jvs.2005.05.049.

Reference Type BACKGROUND
PMID: 16242558 (View on PubMed)

Other Identifiers

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R01AG016685

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AG0098

Identifier Type: -

Identifier Source: org_study_id