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Behavioral Intervention

Supervised Exercise Therapy for Peripheral Arterial Disease (MOMET Trial)

N/A

Recruiting

Led By Iraklis I Pipinos, MD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Demonstrate positive history of chronic claudication

Must not have

Acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma

Rest pain or tissue loss due to PAD (Fontaine stage III and IV)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediate

Awards & highlights

No Placebo-Only Group

Summary

This trial will see if exercise guided by muscle oxygen levels can help people with PAD increase their physical activity without hurting muscle structure & function, reducing cardiovascular risk.

Who is the study for?

This trial is for veterans with Peripheral Arterial Disease (PAD) who can consent, have documented artery blockages in their legs, and experience leg pain when walking. They must be on stable medication regimens for blood pressure, cholesterol, and diabetes. It's not for those with severe PAD causing rest pain or tissue loss, recent ischemic events due to clots or trauma, or walking issues caused by non-PAD conditions.

What is being tested?

The study tests a new supervised exercise program guided by muscle oxygen levels against the standard exercise therapy for PAD patients. The goal is to see if this new method helps increase physical activity without harming muscle structure and function while reducing heart-related risks.

What are the potential side effects?

Since the intervention involves exercise therapy rather than medication, side effects may include typical exercise-related discomforts such as muscle soreness or fatigue but are expected to be minimal compared to drug treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with blocked arteries in my legs.

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I have a history of leg pain when walking.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I recently had a blood clot or injury affecting my leg.

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I have severe leg pain or tissue loss because of poor blood flow.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before exercise, immediately after exercise, 30 minutes after exercise, and 1 hour after exercise

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before exercise, immediately after exercise, 30 minutes after exercise, and 1 hour after exercise

This trial's timeline: 3 weeks for screening, Varies for treatment, and before exercise, immediately after exercise, 30 minutes after exercise, and 1 hour after exercise for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Comprehensive mitochondrial respiratory complex function

Distance walked

Energy expenditure

+6 more

Secondary study objectives

Acceptability

Maximum cadence/day

Metabolic equivalents of task

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Oxygen guided supervised exerciseExperimental Treatment1 Intervention

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.

Group II: Standard supervised exerciseActive Control1 Intervention

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Supervised exercise therapy

2010

N/A

~220

0 / 4Eligibility criteria met