Exercise and Weight Loss for Obese PAD Patients

(PROVE Trial)

Recruiting at 4 trial locations

Overseen By Mary McDermott, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Must not be taking: Weight loss medications

Disqualifiers: Amputation, Major surgery, Cancer, others

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

Compensation: Varies

Number of Visits: 6

Duration: 12 months

212 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a weight loss program combined with walking exercises can improve or maintain the walking ability of individuals with Peripheral Artery Disease (PAD) who are overweight. Participants will either follow a weight loss plan with exercises or only perform the exercises to determine which approach is more effective. The trial seeks individuals with PAD and a BMI over 25 who are interested in improving their walking ability. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance treatment options for PAD.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this weight loss and exercise intervention is safe for obese PAD patients?

Research has shown that both losing weight with exercise and exercising alone are generally safe for people with peripheral artery disease (PAD). In a small study, participants with PAD who followed a weight loss and exercise program lost an average of 5.6 pounds and walked 64.1 meters farther in a 6-minute test, without major safety issues.

Studies on exercise alone have proven it to be an effective treatment for PAD with minimal risks. Participants often experience better walking ability and improved quality of life. These findings suggest that these activities are well-tolerated by people with PAD, with no major negative effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they focus on a holistic approach to tackling obesity in patients with Peripheral Artery Disease (PAD). Unlike standard treatments that often concentrate on medication or surgical interventions, these methods emphasize lifestyle modifications. The combination of weight loss and home-based walking exercise aims to improve circulation and heart health naturally. By empowering patients to actively participate in their own care, these treatments could potentially enhance quality of life and long-term health outcomes.

What evidence suggests that this trial's treatments could be effective for PAD?

This trial will compare the effects of a combined weight loss and exercise program with exercise alone for obese PAD patients. Research has shown that losing weight and exercising can greatly improve walking ability in people with PAD (peripheral artery disease). In an initial study, a similar approach led to an average weight loss of 5.6 pounds and an improvement of 64.1 meters in a six-minute walk test for PAD patients. Losing weight alone is linked to better walking because it can ease the strain on arteries and improve heart health. Studies also indicate that exercise, even by itself, can increase how far and how fast PAD patients can walk. Regular exercise keeps patients active and lowers the risk of PAD worsening. ^{1 2 4 6 7}

Who Is on the Research Team?

Mary McDermott, MD

Principal Investigator

Northwestern University

Walter Ambrosius, PhD

Principal Investigator

Wake Forest University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Peripheral Artery Disease (PAD) and a Body Mass Index (BMI) of more than 25 kg/m2. They should have leg symptoms from PAD that improve with rest, and an ankle brachial index (ABI) below 0.90 or other diagnostic criteria for PAD. People can't join if they've had recent major surgery, are unable to use a smartphone, drink excessively, have certain medical conditions like severe lung disease or cancer under treatment, or if their walking is limited by something other than PAD.

Inclusion Criteria

Your body mass index (BMI) is higher than 25.

I have PAD, confirmed by specific leg blood flow tests showing changes after exercise.

I had surgery to improve blood flow in my legs due to PAD symptoms.

Exclusion Criteria

Unwilling/unable to use a smart phone and unwilling to attend weekly study sessions

Investigator discretion

You drink too much alcohol.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either weight loss + exercise or exercise alone, with interventions including a Group Mediated Cognitive Behavioral framework, connective mobile technology, remote monitoring by a coach, and a calorie-restricted DASH-derived diet

12 months

Regular remote monitoring and periodic in-person assessments

Follow-up

Participants are monitored for changes in six-minute walk distance, exercise adherence, physical activity, and other health metrics

12 months

Follow-up assessments at 6 and 12 months

Exploratory Assessments

In a subset of participants, additional assessments such as calf muscle biopsies are conducted to measure mitochondrial biogenesis, capillary density, and inflammation

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Exercise
• Weight loss

Trial Overview The PROVE Trial tests whether combining weight loss strategies with walking exercises helps people with obesity and PAD walk better after one year compared to just exercise alone. The weight loss program includes group support, mobile tech monitoring by a coach, and a special low-calorie diet called the OMNIHeart diet.

How Is the Trial Designed?

Group I: Weight loss + exercise (WL+EX) Experimental Treatment 2 Interventions

Weight loss + home based walking exercise (WL+EX)

Group II: Exercise alone (EX) Active Control 1 Intervention

Home based walking exercise (EX)

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Wake Forest University

Collaborator

Trials

193

Recruited

151,000+

Published Research Related to This Trial

Physical activity plays a crucial role in weight loss and maintenance, showing a dose-response relationship where increased activity correlates with greater weight loss benefits.

Engaging in physical activity not only aids in weight management for individuals with severe obesity or those who have had bariatric surgery, but it also enhances cardiorespiratory fitness, reducing health risks associated with being overweight or obese.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity and physical activity. Jakicic, JM., Davis, KK.[2011]

Exercise has numerous benefits for individuals with obesity, including aiding in weight loss and improving cardiovascular health, but the direct impact on weight loss from exercise alone is modest, typically resulting in only a few kilograms of weight loss.

Physical activity is crucial for managing type 2 diabetes and preventing its complications, and a structured approach like the 5 A's strategy can help healthcare professionals effectively support patients in overcoming barriers to increasing their physical activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity in management of persons with obesity. Oppert, JM., Bellicha, A., Ciangura, C.[2021]

The PREVAIL-P study will investigate how different amounts of aerobic exercise affect weight maintenance in overweight and obese adults after significant weight loss, involving 39 participants over a total of 28 weeks.

In addition to weight changes, the study will also assess important health factors like blood lipids and glucose tolerance, which are crucial for understanding the overall health benefits of exercise beyond just weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prescribed exercise to Reduce Recidivism After Weight Loss-Pilot (PREVAIL-P): Design, methods and rationale. Swift, DL., McGee, JE., Huff, AC., et al.[2023]

A 6-month physical exercise program significantly improved weight, body mass index (BMI), waist circumference, and cardiovascular health in morbidly obese patients, particularly in those who adhered to the program (≥ 80% attendance).

The adherent group also showed notable improvements in cardiorespiratory fitness and reductions in diastolic blood pressure, basal glycemia, and triglycerides, while the non-adherent group did not experience significant changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptaciones al ejercicio físico en el perfil lipídico y la salud cardiovascular de obesos mórbidos. Delgado-Floody, P., Caamaño-Navarrete, F., Jerez-Mayorga, D., et al.[2022]

The TelePreSET program, which involved 12 weeks of in-home exercise training via telehealth, was highly attended (96%) and well-received by participants, indicating its feasibility for individuals awaiting bariatric surgery.

Participants in the TelePreSET group showed significant improvements in physical fitness compared to those receiving usual care, suggesting that this telehealth approach can effectively enhance fitness levels in women with severe obesity before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and effect of in-home physical exercise training delivered via telehealth before bariatric surgery. Baillot, A., Boissy, P., Tousignant, M., et al.[2018]

Bariatric surgery can lead to weight loss and diabetes remission, but some patients experience weight regain and diabetes relapse over time, indicating that surgery alone may not be sufficient for long-term success.

Incorporating exercise as an adjunct therapy for bariatric surgery patients is suggested to be both feasible and effective, potentially playing a crucial role in maintaining weight loss and sustaining remission of type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and Bariatric Surgery: An Effective Therapeutic Strategy. Coen, PM., Carnero, EA., Goodpaster, BH.[2018]

In a pilot study of 77 overweight and obese adults, those who participated in a 3-month supervised exercise program showed significant improvements in fitness indicators, with 69% attending the gym at least 8 times per month.

However, adherence dropped significantly during the 9-month unsupervised phase, with only 8 out of 24 participants completing it, suggesting that ongoing supervision may be crucial for maintaining exercise habits, especially for individuals with joint symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of an exercise program on adherence and fitness indicators. Carpenter, R., Gilleland, D.[2017]

A network meta-analysis of 45 randomized controlled trials involving 3566 participants found that while any exercise is better than no exercise for people with obesity, the weight loss achieved is generally modest.

Combining high-intensity aerobic exercise with high-load resistance training was shown to be the most effective approach for reducing abdominal fat, improving lean body mass, and enhancing cardiorespiratory fitness, suggesting this combination should be prioritized in exercise prescriptions for adults with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What exercise prescription is optimal to improve body composition and cardiorespiratory fitness in adults living with obesity? A network meta-analysis. O'Donoghue, G., Blake, C., Cunningham, C., et al.[2021]

In a study of 193 obese participants over 18 months, various strategies to enhance exercise adherence were tested, with personal trainers and monetary incentives showing the best results for attendance at supervised walks.

Despite improved attendance with these strategies, they did not lead to higher overall energy expenditure or better long-term weight loss, suggesting that the recommended levels of exercise for effective weight loss may need to be significantly increased.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of personal trainers and financial incentives to increase exercise in a behavioral weight-loss program. Jeffery, RW., Wing, RR., Thorson, C., et al.[2022]

A lifestyle-modification program that includes increased physical activity and a balanced diet can significantly reduce obesity-related health risks, even if there is minimal or no weight loss.

Such lifestyle changes can lead to improvements in abdominal obesity, visceral fat, and cardiometabolic risk factors, as well as increases in muscle mass and cardiorespiratory fitness, highlighting the importance of focusing on health improvements rather than just weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The future of obesity reduction: beyond weight loss. Ross, R., Bradshaw, AJ.[2021]

Combining physical exercise with energy restriction diets leads to greater weight loss than exercise alone, making it the most effective strategy for significant weight loss.

Engaging in at least 150 minutes of moderate-intensity or 75 minutes of vigorous-intensity aerobic exercise weekly, along with resistance training, is recommended for weight loss and maintenance, which also helps improve obesity-related health issues like diabetes and cardiovascular disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity and physical exercise. Celik, O., Yildiz, BO.[2021]

Obesity significantly increases the risk of coronary heart disease (CHD), with over 80% of CHD patients being overweight or obese, highlighting the need for effective weight loss interventions in cardiac rehabilitation (CR) programs.

Behavioral weight loss (BWL) interventions in CR settings lead to significantly greater weight loss compared to standard programs, resulting in improved insulin sensitivity and reductions in hypertension and lipid abnormalities, making BWL a crucial component for managing CHD risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity in coronary heart disease: An unaddressed behavioral risk factor. Ades, PA., Savage, PD.[2018]

Obesity significantly increases the risk of coronary heart disease (CHD), yet most cardiac rehabilitation programs do not effectively address weight loss, leading to poor outcomes in this area.

A new weight reduction strategy combining behavioral counseling and increased exercise, particularly walking, shows promise in improving various health markers in overweight CHD patients, highlighting the need for tailored obesity management in rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The treatment of obesity in cardiac rehabilitation. Ades, PA., Savage, PD., Harvey-Berino, J.[2021]

In a study of 120 patients with stable coronary artery disease, those who were obese showed greater reductions in body mass index (BMI), blood pressure, and LDL cholesterol levels after a 12-week cardiac rehabilitation program compared to non-obese patients.

While obese patients had more significant improvements in certain cardiovascular risk factors, non-obese patients experienced a greater increase in left ventricular ejection fraction (LVEF), indicating different responses to rehabilitation based on obesity status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a phase 2 cardiac rehabilitation program on obese and non-obese patients with stable coronary artery disease. El Missiri, A., Abdel Halim, WA., Almaweri, AS., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3061490/

Exercise Rehabilitation in Peripheral Artery Disease Exercise therapy combined with comprehensive secondary prevention has the potential to benefit patients with PAD by preserving or improving functional capacity.

2. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000000623

Optimal Exercise Programs for Patients With Peripheral ... 6 months of unsupervised intermittent walking exercise was demonstrated to improve time walked to onset of pain and peak walking time (PWT).

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0021915019304149

Physical activity and peripheral artery disease The findings from the longitudinal studies suggest that more intense physical activity is associated with lower risk of developing PAD.

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2809783

Home-Based Walking Exercise and Supervised Treadmill ... Home-based walking exercise was associated with greater improvement in 6MW distance but not treadmill walking distance, in people with PAD.

5. ahajournals.org ahajournals.org/doi/10.1161/JAHA.123.031182?doi=10.1161/JAHA.123.031182

Study Design, Rationale, and Methodology for Promote ... Second, weight loss in people with PAD with overweight/obesity may improve adherence to regular walking exercise, thereby facilitating greater ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10562863/

Exercise Therapy in the Management of Peripheral Arterial ... Uncontrolled PAD can lead to decreased QoL, debility, amputation, and death. Exercise therapy is a first-line treatment for PAD with proven benefit and minimal ...

7. bjsm.bmj.com bjsm.bmj.com/content/54/8/452

Resistance training as a treatment for older persons with ... This analysis has shown that RT alone improves walking ability for persons with PAD. The mechanisms underlying these effects have been explored in few studies.