Oxygen-guided Supervised Exercise Therapy in Peripheral Artery Disease

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Peripheral artery disease (PAD) is a cardiovascular disease manifesting from systemic atherosclerosis, which blocks the leg arteries and results in insufficient blood flow to the lower extremities. Limb ischemia from PAD is the most common disorder treated within the vascular surgery service at the Omaha Veterans' Affairs Medical Center. PAD also accounts for one-third of the operations performed in the VA Medical Centers nationwide. This project aims to establish the feasibility and acceptability of a muscle oxygen-guided supervised exercise program for patients with PAD. The investigators will determine the potential benefits of using this intervention over standard supervised exercise therapy. This modified intervention may enable patients to increase overall physical activity without the negative impacts on muscle structure and function. Increasing physical activity will decrease cardiovascular morbidity and mortality. If proven beneficial, the findings will lead to an improved exercise program that directly benefits veterans nationwide.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
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⁃ At entry into the study, all subjects must:

• Be able to give written, informed consent

• Have documented lower extremity arterial occlusive disease based on ankle/brachial index measurements and/or arterial imaging

• Demonstrate positive history of chronic claudication

• Have a stable blood pressure regimen, stable lipid regimen, stable diabetes regimen and risk factor control for 6 weeks

Locations
United States
Nebraska
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
RECRUITING
Omaha
Contact Information
Primary
Farahnaz Fallahtafti
Farahnaz.Fallahtafti@va.gov
(402) 995-3542
Backup
Sara A Myers, PhD
Sara.Myers2@va.gov
(402) 554-3246
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 12
Treatments
Experimental: Oxygen guided supervised exercise
Modified-SET parameters will be determined from resting StO2 during 10 minutes of sitting. The StO2 threshold will be set at 15% lower than baseline StO2 levels. After warm-up, the subjects will walk until they reach the StO2 threshold. The subjects will be instructed to stop walking once they reach the threshold and to rest until the StO2 level returns to the baseline level. Then, subjects will be instructed to begin walking again and this cycle will be repeated for 50 total minutes. The threshold was selected to be above the 31% drop associated with claudication onset time. If subjects experience pain earlier than the 15% drop, the threshold will be progressively decreased by 5%, as needed. Subjects will repeat this for up to 50 minutes (including walking and rest). Walking speed and treadmill incline will be adjusted to allow for 5-10 minutes of walking before reaching the threshold. Subjects will complete 3 sessions/week for 12 weeks.
Active_comparator: Standard supervised exercise
After the warmup, subjects will walk until claudication pain becomes severe and needs to stop. Then subjects will rest until claudication pain subsides. Afterwards, subjects will walk again, repeating the cycle for up to 50 minutes (including walking and rest). Walking speed and treadmill incline will be adjusted during the SET session to allow individuals with PAD to walk for 5-10 minutes before claudication symptoms arise. Time at each speed and incline, along with rest times will be recorded during each exercise session. Subjects will complete 3 sessions/week for 12 weeks.
Sponsors
Collaborators: University of Nebraska
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov