Exercise for Women With Peripheral Arterial Disease

Peripheral Artery Disease Clinical Trial

Official title:

Exercise for Women With Peripheral Arterial Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01241747
• Other study ID #: HR09-035
• Status: Completed
• Phase: N/A
• Start date: July 2009
• Est. completion date: February 2016

Study information

• Verified date: February 2019
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Claudication
• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Artery Disease
• Peripheral Vascular Diseases
• Women

Intervention

Behavioral:
• Walking Exercise
3 times per week for 3 months
• Control
Resistance training 3 times per week for 3 months

Locations

Country	Name	City	State
United States	Clinical Research Center, Penn State College of Medicine	Hershey	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Oklahoma	Milton S. Hershey Medical Center, Oklahoma Center for the Advancement of Science and Technology

Country where clinical trial is conducted

United States, 

References & Publications (5)

Gardner AW, Katzel LI, Sorkin JD, Bradham DD, Hochberg MC, Flinn WR, Goldberg AP. Exercise rehabilitation improves functional outcomes and peripheral circulation in patients with intermittent claudication: a randomized controlled trial. J Am Geriatr Soc. — View Citation

Gardner AW, Katzel LI, Sorkin JD, Goldberg AP. Effects of long-term exercise rehabilitation on claudication distances in patients with peripheral arterial disease: a randomized controlled trial. J Cardiopulm Rehabil. 2002 May-Jun;22(3):192-8. — View Citation

Gardner AW, Killewich LA, Montgomery PS, Katzel LI. Response to exercise rehabilitation in smoking and nonsmoking patients with intermittent claudication. J Vasc Surg. 2004 Mar;39(3):531-8. — View Citation

Gardner AW, Montgomery PS, Flinn WR, Katzel LI. The effect of exercise intensity on the response to exercise rehabilitation in patients with intermittent claudication. J Vasc Surg. 2005 Oct;42(4):702-9. — View Citation

Gardner AW, Poehlman ET. Exercise rehabilitation programs for the treatment of claudication pain. A meta-analysis. JAMA. 1995 Sep 27;274(12):975-80. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in walking distance to onset of leg pain and the change in walking distance to maximal leg pain		3 months
Primary	Change in 6-minute walk distance		3 months
Secondary	Change in calf muscle oxygen saturation		3 months
Secondary	Change in daily ambulatory activity		3 months
Secondary	Change in walking economy		3 months
Secondary	Change in peak oxygen uptake		3 months