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Exercise Rehabilitation of Younger and Older People With Claudication

NCT ID: NCT00654810

Last Updated: 2008-04-09

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

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

1994-02-28

Study Completion Date

2000-01-31

Brief Summary

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The purpose of this study is to examine the effect of age and the effect of exercise intensity of rehabilitation programs on claudication pain symptoms and leg circulation of younger and older patients with intermittent claudication.

Detailed Description

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Thirty-one patients randomized to low-intensity exercise rehabilitation and 33 patients randomized to high-intensity exercise rehabilitation completed the study. The 6-month exercise rehabilitation programs consisted of intermittent treadmill walking to near maximal claudication pain three days per week at either 40% (low-intensity group) or 80% (high-intensity group) of maximal exercise capacity. Total work performed in the two training regimens was similar by having the patients in the low-intensity group exercise for a longer duration than patients in the high-intensity group. Measurements of physical function, peripheral circulation, and health-related quality of life were obtained on each patient before and after the rehabilitation programs.

Conditions

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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

Outcome Assessors

Study Groups

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1

Low intensity group (40% of maximal exercise capacity)

Group Type EXPERIMENTAL

Walking Exercise

Intervention Type BEHAVIORAL

Intermittent treadmill walking to near maximal claudication pain three days per week

2

High intensity group (80% of maximal exercise capacity)

Group Type EXPERIMENTAL

Walking Exercise

Intervention Type BEHAVIORAL

Intermittent treadmill walking to near maximal claudication pain three days per week

Interventions

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Walking Exercise

Intermittent treadmill walking to near maximal claudication pain three days per week

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* History of intermittent claudication
* Exercise tolerance limited by intermittent claudication during a screening treadmill test
* Ankle/brachial index (ABI) at rest less than 0.90
* Live independently at home

Exclusion Criteria

* Absence of PAD (peripheral artery disease)
* Asymptomatic PAD (Fontaine stage I)
* Rest pain PAD (Fontaine stage III)
* Exercise tolerance limited by factors other than claudication (e.g., coronary artery disease, dyspnea, poorly controlled blood pressure)
* Active cancer, renal disease, or liver disease
* Current use of pentoxifylline or cilostazol medications for the treatment of intermittent claudication
Minimum Eligible Age

45 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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Baltimore VA Medical Center

Baltimore, Maryland, 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 RESULT
PMID: 16242558 (View on PubMed)

Gardner AW, Katzel LI, Sorkin JD, Killewich LA, Ryan A, Flinn WR, Goldberg AP. Improved functional outcomes following exercise rehabilitation in patients with intermittent claudication. J Gerontol A Biol Sci Med Sci. 2000 Oct;55(10):M570-7. doi: 10.1093/gerona/55.10.m570.

Reference Type RESULT
PMID: 11034229 (View on PubMed)

Gardner AW, Montgomery PS, Parker DE. Optimal exercise program length for patients with claudication. J Vasc Surg. 2012 May;55(5):1346-54. doi: 10.1016/j.jvs.2011.11.123. Epub 2012 Mar 28.

Reference Type DERIVED
PMID: 22459748 (View on PubMed)

Other Identifiers

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K01AG000657

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AG0097

Identifier Type: -

Identifier Source: org_study_id