Muscle oxygen-guided supervised exercise for people with peripheral artery disease

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people with peripheral artery disease (narrowed leg arteries) who have long-lasting leg pain when walking (claudication).

Sex

All sexes can join.

Disease stage

Blocked leg arteries shown by ankle/brachial index tests and/or artery imaging, with a history of chronic claudication. People with rest pain or tissue loss (Fontaine stage III and IV) cannot join.

Earlier treatment

Blood pressure, cholesterol and diabetes treatment and risk factor control must have been stable for 6 weeks.

Main reasons for not taking part

• Pain at rest or tissue loss due to PAD (Fontaine stage III and IV)
• A sudden loss of blood flow to the leg from a blood clot or injury
• Walking limited by other problems, such as joint, muscle, nerve, heart or lung disease
• Not able to give written informed consent

The registry criteria, word for word

What the trial wants to find out

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.

The 2 groups in the trial

• Oxygen guided supervised exerciseTreatment being tested

  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.

  Treatment: Supervised exercise therapy

• Standard supervised exerciseExisting treatment, for comparison

  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.

  Treatment: Supervised exercise therapy