Exercise Training for Patients With Poor Leg Circulation

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00118560
First received: June 30, 2005
Last updated: March 16, 2011
Last verified: March 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Perfusion and Metabolism During Exercise in Peripheral Arterial Disease

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • maximal exercise times on treadmill and calf ergometer [ Time Frame: baseline and after 3 months of intervention ] [ Designated as safety issue: No ]

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

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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
Study First Received: June 30, 2005
Last Updated: March 16, 2011
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
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

ClinicalTrials.gov processed this record on September 30, 2014