Supervised Exercise Therapy for Peripheral Arterial Disease

(MOMET Trial)

Overseen By Sara A Myers, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Rest pain, Acute ischemic event, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 36

Duration: 12 weeks

12 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it requires that your blood pressure, lipid, and diabetes medications be stable for 6 weeks before joining.

What data supports the effectiveness of the treatment Supervised Exercise Therapy for Peripheral Arterial Disease?

Research shows that supervised exercise therapy helps people with peripheral artery disease walk longer distances and improves their quality of life. It is considered a first-line treatment and can also improve cardiovascular health, potentially reducing the risk of heart attacks and strokes. ^{1 2 3 4 5}

Is supervised exercise therapy safe for humans?

Supervised exercise therapy is generally considered safe for people with peripheral artery disease, as it is a recommended first-line treatment and has been shown to improve walking distance and quality of life without significant safety concerns. ^{1 2 3 5 6}

How is Supervised Exercise Therapy different from other treatments for peripheral arterial disease?

Supervised Exercise Therapy is unique because it is a first-line treatment that improves walking distances and gait biomechanics in patients with peripheral arterial disease, offering benefits comparable to surgical options without the need for invasive procedures. ^{1 2 3 5 7}

What is the purpose of this trial?

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.

Research Team

Iraklis I Pipinos, MD

Principal Investigator

Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

Eligibility Criteria

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.

Inclusion Criteria

Be able to give written, informed consent

I have been diagnosed with blocked arteries in my legs.

My blood pressure, cholesterol, and diabetes treatments have been stable for 6 weeks.

Exclusion Criteria

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

My walking is limited due to conditions not related to leg pain from poor circulation.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either standard supervised exercise therapy (SET) or oxygen-guided supervised exercise therapy (M-SET) for 12 weeks, with sessions three times per week.

12 weeks

36 sessions (in-person)

Follow-up

Participants are monitored for exercise outcomes, muscle biochemistry, and subject-reported preferences after the intervention.

4 weeks

Open-label extension (optional)

Participants may opt into continuation of exercise therapy long-term if proven beneficial.

Long-term

Treatment Details

Interventions

• Supervised Exercise Therapy

Trial Overview 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.

Participant Groups

Group I: Oxygen guided supervised exercise Experimental Treatment 1 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 exercise Active Control 1 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.

Supervised Exercise Therapy is already approved in United States, European Union for the following indications:

Approved in United States as Supervised Exercise Therapy for:

• Peripheral Artery Disease (PAD)
• Claudication

Approved in European Union as Supervised Exercise Therapy for:

• Peripheral Artery Disease (PAD)
• Claudication

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

University of Nebraska

Collaborator

Trials

563

Recruited

1,147,000+

Findings from Research

A supervised exercise therapy (SET) program for patients with intermittent claudication showed a 20% improvement in walking distance, increasing from an average of 298.5 meters to 360 meters, based on a study involving 155 patients over nearly two years.

The program is cost-effective compared to traditional physiotherapy and is designed to be accessible, with efforts made to increase participation through additional classes and venues, demonstrating the potential for successful implementation of community-based health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a supervised exercise therapy programme. Murgitroyd, E., Fraser, S., Hebson, A., et al.[2020]

In a study of 63 patients with peripheral artery disease (PAD) undergoing a 6-month supervised exercise therapy (SET) program, an increase in walking speed of 0.03 m/s or greater was identified as the minimal clinically important difference (MCID), indicating meaningful improvement in walking ability.

The study established specific thresholds for small and substantial improvements in walking speed, which can help clinicians set realistic goals and assess progress in claudicating patients with PAD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Claudicating patients with peripheral artery disease have meaningful improvement in walking speed after supervised exercise therapy. Rahman, H., Pipinos, II., Johanning, JM., et al.[2022]

Supervised exercise training is an effective first-line therapy for patients with peripheral arterial disease (PAD), significantly improving pain-free walking distance and overall quality of life.

In addition to alleviating symptoms of claudication, supervised exercise training can enhance cardiovascular health and potentially lower the risk of serious events like heart attacks and strokes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of exercise training in peripheral arterial disease. Milani, RV., Lavie, CJ.[2007]

A randomized controlled trial showed that both long-term home exercise programs (HEP) and short-term supervised exercise therapy transitioning to HEP significantly improved peak walking time (PWT) in participants with peripheral artery disease, with PWT increasing from 408 meters to 814 meters in the HEP group and from 457 meters to 818 meters in the SET/HEP group over 18 months.

Both exercise interventions also enhanced exercise time-to-minimum calf muscle oxygen saturation (StO2), indicating improved muscle oxygenation during activity, which was correlated with the improvements in PWT, highlighting the effectiveness of structured exercise in managing symptoms of peripheral artery disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Long-Term Home Exercise in Participants With Peripheral Artery Disease. Gardner, AW., Montgomery, PS., Wang, M., et al.[2023]

In a study of 47 patients with peripheral artery disease (PAD), six months of supervised exercise therapy significantly improved walking distances, quality of life, and maximal plantar flexor strength, despite no significant change in the ankle-brachial index (ABI).

The therapy also enhanced gait biomechanics, particularly in torque and power generation at the ankle and hip, indicating that supervised exercise can effectively improve mobility and function in claudicating patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supervised walking exercise therapy improves gait biomechanics in patients with peripheral artery disease. Schieber, MN., Pipinos, II., Johanning, JM., et al.[2021]

Supervised exercise therapy (SET) has been effectively integrated into cardiopulmonary rehabilitation programs over a 3-year period, demonstrating its potential to improve walking distance for patients with symptomatic peripheral artery disease (PAD).

The recent decision by the Centers for Medicare and Medicaid to cover SET could significantly enhance its adoption in clinical practice, providing a structured approach for rehabilitation therapists to implement SET in their programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience Implementing Supervised Exercise Therapy for Peripheral Artery Disease. Salisbury, DL., Whipple, MO., Burt, M., et al.[2022]

A survey of 84 vascular surgeons in the UK revealed that only 24% had access to supervised exercise programs for patients with intermittent claudication, despite strong recommendations for such programs from major clinical guidelines.

The study highlights a significant gap between evidence-based recommendations and actual practice, with 72% of respondents citing lack of resources as a barrier to implementing supervised exercise, which is known to improve patient outcomes and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supervised exercise for intermittent claudication - an under-utilised tool. Shalhoub, J., Hamish, M., Davies, AH.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Implementation of a supervised exercise therapy programme. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Claudicating patients with peripheral artery disease have meaningful improvement in walking speed after supervised exercise therapy. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The role of exercise training in peripheral arterial disease. [2007]

4. England pubmed.ncbi.nlm.nih.gov

Effects of Long-Term Home Exercise in Participants With Peripheral Artery Disease. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Supervised walking exercise therapy improves gait biomechanics in patients with peripheral artery disease. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Experience Implementing Supervised Exercise Therapy for Peripheral Artery Disease. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Supervised exercise for intermittent claudication - an under-utilised tool. [2022]