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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediate

Awards & highlights

MOMET Trial 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.Check my eligibility

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.See study design

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.

MOMET Trial 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.

MOMET Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Comprehensive mitochondrial respiratory complex function

Distance walked

Energy expenditure

+6 more

Secondary outcome measures

Acceptability

Maximum cadence/day

Metabolic equivalents of task

+5 more

MOMET 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,618 Previous Clinical Trials

3,316,161 Total Patients Enrolled

13 Trials studying Peripheral Arterial Disease

1,450 Patients Enrolled for Peripheral Arterial Disease

University of NebraskaOTHER

541 Previous Clinical Trials

1,144,741 Total Patients Enrolled

13 Trials studying Peripheral Arterial Disease

576 Patients Enrolled for Peripheral Arterial Disease

Iraklis I Pipinos, MDPrincipal InvestigatorOmaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

2 Previous Clinical Trials

145 Total Patients Enrolled

2 Trials studying Peripheral Arterial Disease

145 Patients Enrolled for Peripheral Arterial Disease

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers still recruiting subjects to participate in this experiment?

"According to information on clinicaltrials.gov, this medical study is not currently recruiting participants. Although it was first posted on October 1st of 2023 and last updated in August 24th of the same year, 207 other trials are still actively seeking enrollees at present."

Answered by AI

What are the objectives of this clinical trial?

"This clinical trial seeks to observe the energy expenditure of patients enrolled before and after a 12 week exercise program. Secondary objectives include measuring Physical Activity Enjoyment Scale, Rating of Perceived Exertion, as well as obtaining an average number of steps per day through accelerometer readings."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Oxygen-guided Supervised Exercise Therapy

2023. "Oxygen-guided Supervised Exercise Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06003855.

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