Clinical trial NCT00618670: Home-based vs. Supervised Exercise for People With Claudication
Official title: Home-based vs. Supervised Exercise for Claudicants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intermittent Claudication
Keywords: aging
gait
musculoskeletal disorder therapy
peripheral blood vessel disorder
muscle function
muscle strength
quality of life
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: Oklahoma Center for the Advancement of Science and Technology
name: National Institute on Aging (NIA)
First posted: 2008-02-20
Enrollment: 135
Sex: ALL
Minimum age (years): 35
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain
timeFrame: 3 months
Secondary outcomes:
measure: Change in walking efficiency
timeFrame: 3 months
measure: Change in calf muscle circulation and calf muscle oxygen
timeFrame: 3 months
measure: Change in health-related quality of life
timeFrame: 3 months
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: General Clinical Research Center, University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Andrew W Gardner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. doi: 10.1046/j.1532-5415.2001.49152.x.
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. doi: 10.1097/00008483-200205000-00011.
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. doi: 10.1016/j.jvs.2003.08.037.
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. doi: 10.1016/j.jvs.2005.05.049.
citation: Gardner AW, Parker DE, Montgomery PS. Changes in vascular and inflammatory biomarkers after exercise rehabilitation in patients with symptomatic peripheral artery disease. J Vasc Surg. 2019 Oct;70(4):1280-1290. doi: 10.1016/j.jvs.2018.12.056. Epub 2019 Mar 25.
citation: Gardner AW, Parker DE, Montgomery PS. Predictors of Improved Walking after a Supervised Walking Exercise Program in Men and Women with Peripheral Artery Disease. Int J Vasc Med. 2016;2016:2191350. doi: 10.1155/2016/2191350. Epub 2016 Dec 25.
citation: Gardner AW, Parker DE, Montgomery PS. Sex-specific predictors of improved walking with step-monitored, home-based exercise in peripheral artery disease. Vasc Med. 2015 Oct;20(5):424-31. doi: 10.1177/1358863X15596237. Epub 2015 Aug 3.
citation: Gardner AW, Parker DE, Montgomery PS, Blevins SM. Step-monitored home exercise improves ambulation, vascular function, and inflammation in symptomatic patients with peripheral artery disease: a randomized controlled trial. J Am Heart Assoc. 2014 Sep 18;3(5):e001107. doi: 10.1161/JAHA.114.001107.
citation: Gardner AW, Alaupovic P, Parker DE, Montgomery PS, Esponda OL, Casanegra AI. Influence of peripheral artery disease and statin therapy on apolipoprotein profiles. Int J Vasc Med. 2013;2013:548764. doi: 10.1155/2013/548764. Epub 2013 Sep 11.
citation: Gardner AW, Parker DE, Montgomery PS, Scott KJ, Blevins SM. Efficacy of quantified home-based exercise and supervised exercise in patients with intermittent claudication: a randomized controlled trial. Circulation. 2011 Feb 8;123(5):491-8. doi: 10.1161/CIRCULATIONAHA.110.963066. Epub 2011 Jan 24.