Clinical trial NCT01241747: Exercise for Women With Peripheral Arterial Disease
Official title: Exercise for Women With Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Artery Disease
Claudication
Women
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: Oklahoma Center for the Advancement of Science and Technology
name: Milton S. Hershey Medical Center
First posted: 2010-11-16
Enrollment: 33
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in walking distance to onset of leg pain and the change in walking distance to maximal leg pain
timeFrame: 3 months
measure: Change in 6-minute walk distance
timeFrame: 3 months
Secondary outcomes:
measure: Change in calf muscle oxygen saturation
timeFrame: 3 months
measure: Change in daily ambulatory activity
timeFrame: 3 months
measure: Change in walking economy
timeFrame: 3 months
measure: Change in peak oxygen uptake
timeFrame: 3 months
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Clinical Research Center, Penn State College of Medicine
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine
name: Andrew W Gardner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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. doi: 10.1097/00008483-200205000-00011.
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. doi: 10.1016/j.jvs.2003.08.037.
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. doi: 10.1016/j.jvs.2005.05.049.