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
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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:
MedlinePlus related topics:
Diabetes
Diabetes Type 2
Exercise and Physical Fitness
Peripheral Arterial Disease
U.S. FDA Resources
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
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 Intermittent Claudication Peripheral Arterial Disease Peripheral Vascular Diseases Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Signs and Symptoms Atherosclerosis |
ClinicalTrials.gov processed this record on May 22, 2013