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Exercise for Women With Peripheral Arterial Disease

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ClinicalTrials.gov Identifier: NCT01241747
Recruitment Status : Completed
First Posted : November 16, 2010
Last Update Posted : March 27, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
Peripheral Artery Disease Claudication Women Behavioral: Walking Exercise Behavioral: Control

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exercise for Women With Peripheral Arterial Disease
Study Start Date : July 2009
Primary Completion Date : March 2016
Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01241747


Locations
United States, Oklahoma
General Clinical Research Center, University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73117
Sponsors and Collaborators
University of Oklahoma
Oklahoma Center for the Advancement of Science and Technology
Investigators
Principal Investigator: Andrew W Gardner, PhD University of Oklahoma
More Information

Publications:
Responsible Party: Andrew Gardner, Professor, University of Oklahoma
ClinicalTrials.gov Identifier: NCT01241747     History of Changes
Other Study ID Numbers: HR09-035
First Posted: November 16, 2010    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases