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Exercise for Women With Peripheral Arterial Disease

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by University of Oklahoma.
Recruitment status was:  Recruiting
Oklahoma Center for the Advancement of Science and Technology
Information provided by (Responsible Party):
Andrew Gardner, University of Oklahoma Identifier:
First received: November 15, 2010
Last updated: December 2, 2014
Last verified: December 2014

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.

Condition Intervention
Peripheral Artery Disease
Behavioral: Walking Exercise
Behavioral: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exercise for Women With Peripheral Arterial Disease

Resource links provided by NLM:

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Change in walking distance to onset of leg pain and the change in walking distance to maximal leg pain [ Time Frame: 3 months ]
  • Change in 6-minute walk distance [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Change in calf muscle oxygen saturation [ Time Frame: 3 months ]
  • Change in daily ambulatory activity [ Time Frame: 3 months ]
  • Change in walking economy [ Time Frame: 3 months ]
  • Change in peak oxygen uptake [ Time Frame: 3 months ]

Estimated Enrollment: 74
Study Start Date: July 2009
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01241747

Contact: Polly S Montgomery, MS 405-271-6764

United States, Oklahoma
General Clinical Research Center, University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73117
Contact: Polly S Montgomery, MS    405-271-6764   
Principal Investigator: Andrew W Gardner, PhD         
Sponsors and Collaborators
University of Oklahoma
Oklahoma Center for the Advancement of Science and Technology
Principal Investigator: Andrew W Gardner, PhD University of Oklahoma
  More Information

Responsible Party: Andrew Gardner, Professor, University of Oklahoma Identifier: NCT01241747     History of Changes
Other Study ID Numbers: HR09-035 
Study First Received: November 15, 2010
Last Updated: December 2, 2014

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases processed this record on February 23, 2017