Exercise for Women With Peripheral Arterial Disease

Hypothesis #1. Supervised exercise rehabilitation will result in greater increases in exercise performance, peripheral vascular function, and health-related quality of life than compared to the attention-control group.

Hypothesis #2. The change in peripheral vascular function will be predictive of improved exercise performance following the supervised exercise program.

Study Overview

• Status: Completed
• Conditions: Peripheral Artery Disease; Claudication; Women
• Intervention / Treatment: Behavioral: Walking Exercise; Behavioral: Control

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Clinical Research Center, Penn State College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• women 60 years of age and older having a 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
• an ankle/brachial index (ABI) < 0.90 at rest or < 0.73 immediately following the treadmill exercise test
• at least one year past menopause

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.)
• use of medications indicated for the treatment of intermittent claudication (cilostazol and pentoxifylline) initiated within three months prior to investigation)
• cognitive dysfunction (mini-mental state examination score < 24)
• active cancer, renal disease, or liver disease
• a calf skin fold measurement > 50 mm, because of potential interference with the light path of the near-infrared spectroscopy probe from penetrating the subcutaneous tissue
• pulse arterial oxygen saturation of the index finger < 95% because of the potential deleterious effect on calf muscle StO2 from poor pulmonary gas exchange

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supervised Exercise; Supervised program consisting of graded treadmill walking, with progressive increments in exercise duration from 15 to 40 minutes at an exercise intensity of 40% of exercise capacity.	Behavioral: Walking Exercise; 3 times per week for 3 months
Active Comparator: Control; Light resistance training without any walking	Behavioral: Control; Resistance training 3 times per week for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in walking distance to onset of leg pain and the change in walking distance to maximal leg pain	3 months
Change in 6-minute walk distance	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in calf muscle oxygen saturation	3 months
Change in daily ambulatory activity	3 months
Change in walking economy	3 months
Change in peak oxygen uptake	3 months

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Collaborators: Milton S. Hershey Medical Center; Oklahoma Center for the Advancement of Science and Technology
• Investigators: Principal Investigator: Andrew W Gardner, PhD, Penn State College of Medicine

Publications and helpful links

General Publications

• 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.
• Gardner AW, Poehlman ET. Exercise rehabilitation programs for the treatment of claudication pain. A meta-analysis. JAMA. 1995 Sep 27;274(12):975-80.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: November 15, 2010
• First Submitted That Met QC Criteria: November 15, 2010
• First Posted (Estimate): November 16, 2010

Study Record Updates

• Last Update Posted (Actual): March 1, 2019
• Last Update Submitted That Met QC Criteria: February 27, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: HR09-035