Expired Study
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Baltimore, Maryland 21201


Purpose:

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.


Study summary:

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.


Criteria:

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


Study is Available At:


Original ID:

AG0097


NCT ID:

NCT00654810


Secondary ID:

K01-AG-00657


Study Acronym:


Brief Title:

Exercise Rehabilitation of Younger and Older People With Claudication


Official Title:

Exercise Rehabilitation of Younger and Older People With Claudication


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

45 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:

64


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:February 1994
Completion Date:January 2000
Completion Type:Actual
Primary Completion Date:January 2000
Primary Completion Type:Actual
Verification Date:April 2008
Last Changed Date:April 7, 2008
First Received Date:April 7, 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.
Time Frame:6 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Changes in cardiopulmonary function, calf muscle circulation, and health-related quality of life.
Time Frame:6 months
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Walking Exercise
Description:Intermittent treadmill walking to near maximal claudication pain three days per week
Arm Name:1

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:Low intensity group (40% of maximal exercise capacity)
Study Arm Type:Experimental
Arm Name:2
Description:High intensity group (80% of maximal exercise capacity)

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:Results 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
Reference Type:Results Reference
Citation: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.
PMID:11034229

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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