Home-based vs. Supervised Exercise for People With Claudication

NCT00618670 | Completed DMC

• 2 other identifiers: AG0095R01AG024296
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Intermittent Claudication

Keywords

aging; gait; musculoskeletal disorder therapy; peripheral blood vessel disorder; muscle function; muscle strength; quality of life

Outcome Measures

Primary Outcomes (1)

• Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain

  3 months

Secondary Outcomes (3)

• Change in walking efficiency

  3 months

• Change in calf muscle circulation and calf muscle oxygen

  3 months

• Change in health-related quality of life

  3 months

Study Arms (3)

1

EXPERIMENTAL

Home-based program with progressive increases in exercise duration and intensity (i.e., cadence); walking duration will be longer for the home-based group because the intensity of walking will be lower than the graded treadmill walking performed by the supervised group

Behavioral: Walking Exercise

2

EXPERIMENTAL

Supervised program consisting of graded treadmill walking, with progressive increments in exercise duration from 15 to 40 minutes, and progressive increments in exercise intensity from 50 to 70% of exercise capacity

Behavioral: Walking Exercise

3

ACTIVE COMPARATOR

Light resistance training without any walking exercise

Behavioral: Control--Resistance Training

Interventions

Walking Exercise BEHAVIORAL

Three times per week for 3 months

1; 2

Control--Resistance Training BEHAVIORAL

Three times per week for 3 months

3

Eligibility Criteria

• Age: 35 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Oklahoma: lead
• Oklahoma Center for the Advancement of Science and Technology: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

General Clinical Research Center, University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73117, United States

Location

Related Publications (12)

• 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 BACKGROUND

• 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.

  PMID: 11454114 BACKGROUND

• 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.

  PMID: 12042688 BACKGROUND

• 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.

  PMID: 14981444 BACKGROUND

• 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.

  PMID: 16242558 BACKGROUND

• Gardner AW, Montgomery PS, Wang M, Liang M. Effects of Long-Term Home Exercise in Participants With Peripheral Artery Disease. J Am Heart Assoc. 2023 Nov 7;12(21):e029755. doi: 10.1161/JAHA.122.029755. Epub 2023 Nov 6.

  PMID: 37929770 DERIVED

• 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.

  PMID: 30922751 DERIVED

• 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.

  PMID: 28116164 DERIVED

• 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.

  PMID: 26240075 DERIVED

• 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.

  PMID: 25237048 DERIVED

• 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.

  PMID: 24102029 DERIVED

• 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.

  PMID: 21262997 DERIVED

MeSH Terms

Conditions

Intermittent Claudication; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew W Gardner, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2008
• First Posted: February 20, 2008
• Study Start: September 1, 2006
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: April 2, 2018

Record last verified: 2018-03

Locations

US (1)