Exercise Training for Patients With Poor Leg Circulation

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 2, Intermittent Claudication

In brief

The purposes of this pilot project are to (a) determine changes in calf muscle blood flow and energy supply resulting from calf muscle exercise, and (b) to determine changes in these variables resulting from exercise training (walking and calf muscle exercise). This is a pilot study to prepare for a larger project in the future. Exercise and exercise training should increase blood flow and energy supply to the calf muscles.

Key facts

Study ID

NCT00118560

Run by

US Department of Veterans Affairs

People needed

50

Starts

2005-06-01

Expected to finish

2007-12-01

Last updated by the study team

2011-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Group I (n=25 PAD patients). This sample will represent the population of veterans with PAD with mild mobility impairment secondary to intermittent claudication in the gastrocsoleus muscles.
• Inclusion Criteria for PAD Subjects:
• diagnosis of PAD (acute or chronic occlusive arterial disease), with or without diabetes mellitus
• positive Edinburgh Claudication Questionnaire
• Fontaine stage IIa only (mild claudication, walking distance > 200 feet (one-half block)
• ambulatory, without assistive devices
• calf muscle claudication within 10 minutes of treadmill walking and calf muscle exercise
• Group II (n=25 normal control/reference subjects). This reference sample will represent the population of adults without PAD and related problems. They will undergo the PET-exercise testing for perfusion and glucose metabolism measurements, but will not perform the exercise training intervention.
• Inclusion Criteria for Controls:
• healthy adults, matched by age and sex to PAD subjects

You may not qualify if…

• Exclusion Criteria for PAD and Control Subjects
• PAD secondary to Buerger's disease, autoimmune arteritis, fibromuscular dysplasia, chronic and repetitive occupational trauma, venous stasis, hypercoagulability disorder, or arterial embolic disease.
• inability to perform ankle dorsi and plantar flexion exercise
• cigarette smoking within last 6 months
• severe claudication, leg rest pain, skin ulceration, necrosis or gangrene (Fontaine stage >= IIa)
• poorly controlled diabetes mellitus (bA1c >= 9%)
• poorly controlled hypertension (resting BP > 140/90 mmHg)
• Raynaud's syndrome
• changes in prescribed cardiovascular medications within the past 6 months
• exertional angina, dyspnea, fatigue, or dizziness
• severe coronary artery disease
• congestive heart failure
• severe COPD
• exercise intolerance limited by leg pain of nonvascular origin (e.g., arthritis, orthopedic pain)
• transmetatarsal or more proximal lower-extremity amputation
• nonambulatory in the last 6 months
• severe leg weakness preventing leg exercise
• surgery related to PAD during preceding 3 months
• myocardial infarction within preceding 3 months
• unstable claudication symptoms during preceding 3 months
• terminal disease with < 6 months prognosis
• dementia (Minimental score < 24) (Folstein et al., 1975)
• pregnancy (Females of childbearing potential will be given a pregnancy test prior to acceptance into the study.)

Where it is running

• VA Greater Los Angeles Healthcare System, West LA — West Los Angeles, California, United States

Full record on ClinicalTrials.gov

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