Skip to main content
OpenTrials
Completed

NCT Number: NCT01241747

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Peripheral Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Claudication Intermittent Claudication Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases Women

Age range

60 year–100 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Research Center, Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Walking exercise

Behavioral

3 times per week for 3 months

Control

Behavioral

Resistance training 3 times per week for 3 months

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

  • Milton S. Hershey Medical Center
  • Oklahoma Center for the Advancement of Science and Technology

Registry information

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Nov 16, 2010
Registry last updated
Mar 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.