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Exercise for Women With Peripheral Arterial Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by University of Oklahoma.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Oklahoma Center for the Advancement of Science and Technology
Information provided by:
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT01241747
First received: November 15, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

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
Claudication
Women
 Behavioral: Walking Exercise
Behavioral: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
  • Change in 6-minute walk distance [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in calf muscle oxygen saturation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Change in daily ambulatory activity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Change in walking economy [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Change in peak oxygen uptake [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 74
Study Start Date: July 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (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

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01241747

Contacts
Contact: Polly S Montgomery, MS 405-271-6764 polly-montgomery@ouhsc.edu

Locations
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     polly-montgomery@ouhsc.edu    
Principal Investigator: Andrew W Gardner, PhD            
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 W. Gardner, PhD, University of Oklahoma Health Sciences Center
ClinicalTrials.gov Identifier: NCT01241747     History of Changes
Other Study ID Numbers: HR09-035
Study First Received: November 15, 2010
Last Updated: November 15, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013