Expired Study
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Oklahoma City, Oklahoma 73117


Purpose:

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.


Study summary:

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.


Criteria:

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)


Study is Available At:


Original ID:

AG0098


NCT ID:

NCT00667290


Secondary ID:

R01-AG-16685


Study Acronym:


Brief Title:

Exercise for Elderly Peripheral Revascularized Patients


Official Title:

Exercise for Elderly Peripheral Revascularized Patients


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

40 Years


Maximum Age:

90 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute on Aging (NIA)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

80


Enrollment Type:

Actual


Overall Contact Information

Official Name:Andrew W. Gardner, PhD
Principal Investigator
University of Oklahoma

Study Dates

Start Date:July 2000
Completion Date:June 2007
Completion Type:Actual
Primary Completion Date:June 2007
Primary Completion Type:Actual
Verification Date:April 2008
Last Changed Date:April 24, 2008
First Received Date:April 24, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Changes in walking efficiency, calf muscle circulation, and cardiopulmonary function.
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Treadmill exercise
Description:Graded treadmill walking 3 times per week for 3 months
Arm Name:1

Study Arms

Study Arm Type:Experimental
Arm Name:1
Study Arm Type:No Intervention
Arm Name:2

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute on Aging (NIA)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Gardner AW, Poehlman ET. Exercise rehabilitation programs for the treatment of claudication pain. A meta-analysis. JAMA. 1995 Sep 27;274(12):975-80.
PMID:7674529
Reference Type:Reference
Citation: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.
PMID:11454114
Reference Type:Reference
Citation: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.
PMID:12042688
Reference Type:Reference
Citation: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.
PMID:14981444
Reference Type:Reference
Citation: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.
PMID:16242558

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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