Home-based vs. Supervised Exercise for People With Claudication

Intermittent Claudication Clinical Trial

Official title:

Home-based vs. Supervised Exercise for Claudicants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00618670
• Other study ID #: AG0095
• Secondary ID: R01AG024296
• Status: Completed
• Phase: N/A
• First received: February 15, 2008
• Last updated: March 30, 2018
• Start date: September 2006
• Est. completion date: September 2016

Study information

• Verified date: March 2018
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine the effects of a home-based exercise rehabilitation program compared to a supervised exercise program on intermittent claudication (leg pain or discomfort) and ambulatory function.

Description:

This study seeks to 1) compare the changes in ambulatory function, vascular function, and health-related quality of life in patients limited by intermittent claudication following a home-based exercise rehabilitation program, a supervised exercise program, and a light resistance training exercise program; and 2) determine whether changes in walking efficiency, calf muscle circulation, and calf muscle oxygen are the reasons by which both home-based and supervised exercise rehabilitation improve ambulatory function.

We hypothesize that a home-based exercise program utilizing new physical activity monitoring technology that can accurately quantify exercise adherence as well as the intensity, duration, and volume of exercise sessions will result in similar changes in ambulatory function, vascular function, and health-related quality of life compared to a standard, supervised exercise program. Further, both the home-based and supervised exercise rehabilitation programs will result in greater changes in ambulatory function, vascular function, and health-related quality of life than a light resistance training exercise program. Finally, we hypothesize that the changes in walking efficiency, calf muscle circulation, and calf muscle oxygen will each be predictive of improved ambulation following the home-based exercise program as well as the supervised exercise program.

The 3-month program will consist of walking 3 times per week, with progressive increases in duration and intensity. The two walking exercise programs will be matched on the estimated caloric expenditure during the training sessions. Patients in the control group will perform light resistance training without any walking exercise.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 100 Years

Eligibility

Inclusion Criteria:

• Positive history of intermittent claudication assessed by the San Diego Claudication Questionnaire

• Exercise limited by intermittent claudication during a screening treadmill test using the Gardner protocol

• Ankle/brachial index (ABI) less than 0.90 at rest, which decreases to less than 0.73 immediately following the treadmill exercise test

Exclusion Criteria:

• Absence of PAD (peripheral artery disease)

• Asymptomatic PAD (Fontaine stage I)

• Rest pain due to PAD (Fontaine stage III)

• Tissue loss due to PAD (Fontaine stage IV)

• 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 less than 24)

Related Conditions & MeSH terms

• Intermittent Claudication

Intervention

Behavioral:
• Walking Exercise
Three times per week for 3 months
• Control--Resistance Training
Three times per week for 3 months

Locations

Country	Name	City	State
United States	General Clinical Research Center, University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (3)

Lead Sponsor	Collaborator
University of Oklahoma	National Institute on Aging (NIA), Oklahoma Center for the Advancement of Science and Technology

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain		3 months
Secondary	Change in walking efficiency		3 months
Secondary	Change in calf muscle circulation and calf muscle oxygen		3 months
Secondary	Change in health-related quality of life		3 months