Exercise Training for Patients With Poor Leg Circulation - Full Text View

Sponsored by:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00118560

Purpose

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.

Condition	Intervention
Diabetes Mellitus, Type 2 Intermittent Claudication	Behavioral: Physical exercise Behavioral: Physical walking and calf muscle exercise

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Perfusion and Metabolism During Exercise in Peripheral Arterial Disease

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment:	50
Study Start Date:	June 2005
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1	Behavioral: Physical exercise Behavioral: Physical walking and calf muscle exercise

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.)

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00118560

Locations

United States, California
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, United States, 90073

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Principal Investigator:

Stephen F. Figoni

VA Greater Los Angeles Healthcare System, West LA

More Information

Publications:

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.

Responsible Party:	Department of Veterans Affairs ( Figoni, Stephen - Principal Investigator )
Study ID Numbers:	B3644P
Study First Received:	June 30, 2005
Last Updated:	March 31, 2008
ClinicalTrials.gov Identifier:	NCT00118560 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

Collateral Circulation
Exercise Therapy
Microcirculation

Oxygen
Positron-emission tomography
Walking

Study placed in the following topic categories:

Arterial Occlusive Diseases
Peripheral Vascular Diseases
Metabolic Diseases
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Arteriosclerosis

Signs and Symptoms
Diabetes Mellitus, Type 2
Intermittent Claudication
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Signs and Symptoms
Metabolic Diseases
Peripheral Vascular Diseases
Diabetes Mellitus, Type 2
Vascular Diseases

Diabetes Mellitus
Endocrine System Diseases
Intermittent Claudication
Cardiovascular Diseases
Arteriosclerosis
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on September 09, 2009