Exercise for Women With Peripheral Arterial Disease

NCT01241747 | Completed

• 1 other identifier: HR09-035
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Artery Disease; Claudication; Women

Outcome Measures

Primary Outcomes (2)

• Change in walking distance to onset of leg pain and the change in walking distance to maximal leg pain

  3 months

• Change in 6-minute walk distance

  3 months

Secondary Outcomes (4)

• Change in calf muscle oxygen saturation

  3 months

• Change in daily ambulatory activity

  3 months

• Change in walking economy

  3 months

• Change in peak oxygen uptake

  3 months

Study Arms (2)

Supervised Exercise

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

Light resistance training without any walking

Behavioral: Control

Interventions

Walking Exercise BEHAVIORAL

3 times per week for 3 months

Supervised Exercise

Control BEHAVIORAL

Resistance training 3 times per week for 3 months

Control

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead
• Oklahoma Center for the Advancement of Science and Technology: collaborator
• Milton S. Hershey Medical Center: collaborator

Study Sites (1)

Clinical Research Center, Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (5)

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

  PMID: 7674529 RESULT

• 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. 2001 Jun;49(6):755-62. doi: 10.1046/j.1532-5415.2001.49152.x.

  PMID: 11454114 RESULT

• 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. doi: 10.1097/00008483-200205000-00011.

  PMID: 12042688 RESULT

• 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. doi: 10.1016/j.jvs.2003.08.037.

  PMID: 14981444 RESULT

• 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. doi: 10.1016/j.jvs.2005.05.049.

  PMID: 16242558 RESULT

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew W Gardner, PhD

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2010
• First Posted: November 16, 2010
• Study Start: July 1, 2009
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: March 1, 2019

Record last verified: 2019-02

Locations

US (1)