Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT00118560
Eligibility Criteria:
Inclusion Criteria:
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 Criteria:
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.)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00118560
Study Brief:
Protocol Section:
NCT00118560