Status:
COMPLETED
Exercise Training for Patients With Poor Leg Circulation
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Diabetes Mellitus, Type 2
Intermittent Claudication
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 resulti...
Detailed Description
Specific Objectives: 1.Develop an appropriate graded calf exercise test protocol for evaluating perfusion and metabolism during exercise in subjects with peripheral arterial disease (PAD), 2.compare p...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.)
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00118560
Start Date
June 1 2005
End Date
December 1 2007
Last Update
March 17 2011
Active Locations (1)
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1
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, United States, 90073