Supervised Exercise Therapy for Peripheral Arterial Disease
(MOMET Trial)
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VA Office of Research and Development
Disqualifiers: Rest pain, Acute ischemic event, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
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.
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.
12345Is 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.
12356How 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.
12357Eligibility 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.
+1 more
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.
Trial 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
Participant Groups
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.
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NEOmaha, NE
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Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
University of NebraskaCollaborator
References
Implementation of a supervised exercise therapy programme. [2020]Guidelines for peripheral vascular disease state that supervised exercise therapy (SET) programmes improve walking distance and quality of life in patients with intermittent claudication. This paper outlines the steps needed to implement a successful SET programme and discusses some of the challenges.
Claudicating patients with peripheral artery disease have meaningful improvement in walking speed after supervised exercise therapy. [2022]Supervised exercise therapy (SET) is a first-line treatment for patients with peripheral artery disease (PAD). The efficacy of SET is most commonly expressed by significant statistical improvement of parameters that do not clarify how each individual patient will benefit from SET. This study examined the minimal clinically important difference (MCID) in walking speed in claudicating patients with PAD after SET.
The role of exercise training in peripheral arterial disease. [2007]Peripheral arterial disease (PAD) is currently a major health problem affecting 8-12 million Americans, 15-40% of whom will have intermittent claudication that can lead to substantial impairment in their ability to carry out normal daily activities as well as perform the recommended cardiovascular exercise. Supervised exercise training is an effective tool in the treatment of claudication and is currently a recommended first-line therapy for patients with this condition. In addition to improving pain-free walking distance and quality of life, supervised exercise training can improve many cardiovascular risk factors, possibly reducing the risk for subsequent myocardial infarction, stroke, and death. This paper will review the benefits of supervised exercise training in patients with PAD.
Effects of Long-Term Home Exercise in Participants With Peripheral Artery Disease. [2023]Background This randomized controlled trial compared long-term changes in peak walking time (PWT) and exercise time-to-minimum calf muscle oxygen saturation (StO2) in symptomatic participants with peripheral artery disease following a long-term home exercise program (HEP), a short-term supervised exercise therapy (SET) program that transitioned to a long-term HEP (SET/HEP), and a control intervention. Methods and Results For the first 3 months, HEP and SET/HEP groups performed intermittent walking to mild-to-moderate claudication pain, whereas the control group performed light resistance training. For the subsequent 15 months, the HEP group continued their exercise program, the SET/HEP group transitioned from SET to the HEP program, and the control group transitioned to only receive walking advice. PWT increased significantly from baseline to month 18 in the HEP group (408±279 meters to 814±393 meters, P<0.001) and in the SET/HEP group (457±288 meters to 818±313 meters, P<0.001). Exercise time-to-minimum calf muscle StO2 increased significantly from baseline to month 18 in the HEP group (238±241 seconds to 497±485 seconds, P<0.05) and in the SET/HEP group (296±289 seconds to 620±450 seconds, P<0.001). These changes in PWT and exercise time-to-minimum calf muscle StO2 were greater than in the control group (P<0.001 and P<0.01, respectively). Additionally, the change in exercise time-to-minimum calf muscle StO2 was correlated with the change in PWT in both exercise groups combined (r=0.601, P=0.0015). Conclusions Long-term HEP and SET/HEP were efficacious in improving PWT and exercise time-to-minimum calf muscle StO2 in symptomatic participants with peripheral artery disease, and these changes were correlated with each other. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT00618670.
Supervised walking exercise therapy improves gait biomechanics in patients with peripheral artery disease. [2021]In patients with peripheral artery disease (PAD), supervised exercise therapy is a first line of treatment because it increases maximum walking distances comparable with surgical revascularization therapy. Little is known regarding gait biomechanics after supervised exercise therapy. This study characterized the effects of supervised exercise therapy on gait biomechanics and walking distances in claudicating patients with PAD.
Experience Implementing Supervised Exercise Therapy for Peripheral Artery Disease. [2022]Supervised exercise therapy (SET) is a cornerstone of treatment for improving walking distance for individuals with symptomatic peripheral artery disease and claudication. High quality randomized controlled trials have documented the efficacy of SET as a claudication treatment and led to the recent Centers for Medicare and Medicaid decision to cover supervised exercise therapy (SET). However, to date, the translation of highly controlled, laboratory based SET programs in real world cardiopulmonary rehabilitation settings has been unexplored.
Supervised exercise for intermittent claudication - an under-utilised tool. [2022]The use of supervised exercise in the management of intermittent claudication is well supported by level I evidence upon which are based grade A recommendations by the TASC II Inter-Society Consensus for the Management of Peripheral Arterial Disease and the Scottish Intercollegiate Guidelines Network (SIGN). These include that supervised exercise should be made available as part of the initial treatment for all peripheral arteriopaths.