Near-Infrared Spectroscopy-Guided Exercise Training in Peripheral Arterial Disease
Peripheral Arterial Disease
About this trial
This is an interventional other trial for Peripheral Arterial Disease
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Placebo Comparator
Traditional exercise therapy
Oxygen guided exercise therapy
Control
Training will be performed three times a week for 12 weeks. Each session will take place on a GaitKeeper treadmill (Sammons Preston, IL) treadmill and will last 45 minutes with a 5 minute warm up and cool down of either cycling or walking.
Training will be performed three times a week for 12 weeks. Each session will take place on a GaitKeeper treadmill (Sammons Preston, IL) treadmill and will last 45 minutes with a 5 minute warm up and cool down of either cycling or walking. All patients will be outfitted during exercise with the PortaMon NIRS device on the most affected calf (including subjects in the symptom-driven exercise cohort). The intensity of training will be adjusted to either pain (claudication) rating or oxygen tension. In preliminary studies, a 50% reduction in the tissue saturation index is typically not associated with severe claudication and will be used as the lower level threshold to gauge physical effort (i.e., if subjects do not desaturate by >50% then the intensity of training - the walking pace - will be increased). The training duration, intensity, pain rating, and oxygen tension will be recorded.
Patients will be advised to walk independently.