Exercise for Women With Peripheral Arterial Disease

University of Oklahoma (OU)

Status: Completed

Conditions: Claudication; Peripheral Artery Disease; Women

Treatments: Behavioral: Walking Exercise; Behavioral: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT01241747

HR09-035

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: Female

Ages: 60 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

33 participants in 2 patient groups

Supervised Exercise

Experimental group

Description:

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.

Treatment:

Behavioral: Walking Exercise

Control

Active Comparator group

Description:

Light resistance training without any walking

Treatment:

Behavioral: Control