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Exercise Training for Patients With Poor Leg Circulation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00118560
First Posted: July 11, 2005
Last Update Posted: March 17, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
VA Office of Research and Development
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Perfusion and Metabolism During Exercise in Peripheral Arterial Disease

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • maximal exercise times on treadmill and calf ergometer [ Time Frame: baseline and after 3 months of intervention ]

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
Experimental: 1
treadmill walking and calf exercise
Behavioral: Physical exercise
treadmill walking
Behavioral: Physical walking
calf muscle exercise

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00118560


Locations
United States, California
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, United States, 90073
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Stephen F. Figoni VA Greater Los Angeles Healthcare System, West LA
  More Information

Publications:
Responsible Party: Figoni, Stephen - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00118560     History of Changes
Other Study ID Numbers: B3644P
First Submitted: June 30, 2005
First Posted: July 11, 2005
Last Update Posted: March 17, 2011
Last Verified: March 2011

Keywords provided by VA Office of Research and Development:
Collateral Circulation
Exercise Therapy
Microcirculation
Oxygen
Positron-emission tomography
Walking

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Peripheral Arterial Disease
Intermittent Claudication
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Signs and Symptoms