Status:
COMPLETED
Near-Infrared Spectroscopy-Guided Exercise Training in Peripheral Arterial Disease
Lead Sponsor:
Augusta University
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
40-85 years
Phase:
EARLY_PHASE1
Brief Summary
Background: Patients suffering with atherosclerotic peripheral arterial disease (PAD) have limited therapeutic options to improve claudication. Supervised exercise programs are generally effective in ...
Eligibility Criteria
Inclusion
- Male and female subjects
- Clinically stable symptoms of intermittent claudication from PAD (with no change in symptom severity in the 2 months prior to screening.)
- On stable medical therapy for previous 3 months.
- Able to achieve Total Walking Time (TWT) between 1 and 12 minutes on a standardized Gardner treadmill protocol.
- PAD will be defined by the presence of a Doppler-derived ankle-brachial index (ABI) of \< 0.85 in the symptomatic limb after 10 minutes of rest at screening. For subjects with an ABI of \>1.3 (non-compressible arteries) a Toe-Brachial Index (TBI) of \< 0.70 must be obtained for subject qualification, or if ABI is \> 0.85 to 1.0, and a reduction of 20% in ABI measured within 1 minute of treadmill testing.
Exclusion
- Critical limb ischemia either chronic (category 3 and 4 of SVS classification) or acute ischemia manifested by rest pain, ulceration, or gangrene;
- Lower extremity vascular surgery, angioplasty or lumbar sympathectomy within 3 months of enrollment
- Unstable angina, myocardial infarction, transient ischemic attack, stroke or revascularization in the preceding 4 months;
- Severe heart failure (Class III or IV);
- Limitation on exercise for symptoms other than intermittent claudication such as arthritis or severe dyspnea;
- Alcohol or drug abuse, or any other disease process that, in the opinion of the PI, will interfere with the ability of the patient to participate in the study.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2016
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03478085
Start Date
June 1 2013
End Date
May 31 2016
Last Update
March 27 2018
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