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Exercise for Women With Peripheral Arterial Disease

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ClinicalTrials.gov Identifier: NCT01241747
Recruitment Status : Recruiting
First Posted : November 16, 2010
Last Update Posted : February 8, 2018
Sponsor:
Collaborators:
Oklahoma Center for the Advancement of Science and Technology
Milton S. Hershey Medical Center
Information provided by (Responsible Party):
Andrew Gardner, Milton S. Hershey Medical Center

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 Phase
Peripheral Artery Disease Claudication Women Behavioral: Walking Exercise Behavioral: Control Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 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
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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 ]


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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

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


Contacts
Contact: Polly S Montgomery, MS 717-531-0003 pmontgomery1@pennstatehealth.psu.edu

Locations
United States, Pennsylvania
Clinical Research Center, Penn State College of Medicine Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Polly S Montgomery, MS    717-531-0003 ext 284679    pmontgomery1@pennstatehealth.psu.edu   
Principal Investigator: Andrew W Gardner, PhD         
Sponsors and Collaborators
University of Oklahoma
Oklahoma Center for the Advancement of Science and Technology
Milton S. Hershey Medical Center
Investigators
Principal Investigator: Andrew W Gardner, PhD Penn State College of Medicine

Publications of Results:
Responsible Party: Andrew Gardner, Professor, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01241747     History of Changes
Other Study ID Numbers: HR09-035
First Posted: November 16, 2010    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018

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