Trial Summary
What is the purpose of this trial?The PROVE Trial is a randomized clinical trial that will determine whether a weight loss intervention combined with walking exercise achieves greater improvement or less decline in six-minute walk distance at 12 month follow-up than walking exercise alone in people with PAD and BMI\>25 kg/m2. The intervention uses a Group Mediated Cognitive Behavioral framework, connective mobile technology, remote monitoring by a coach, and a calorie restricted Dietary Approaches to Stop Hypertension (DASH)-derived Optimal Macronutrient Intake Trial for Heart Health (OMNIHeart) diet.
212 participants with PAD and BMI \> 25 kg/m2 will be randomized to one of two groups: weight loss + exercise (WL+EX) vs. exercise alone (EX). Participants will be randomized at Northwestern, Tulane University, and University of Minnesota. Our primary outcome is change in six-minute walk distance at 12-month follow-up. Secondary outcomes are change in 6-minute walk distance at 6-month follow-up and change in exercise adherence, physical activity, patient-reported walking ability (measured by the Walking Impairment Questionnaire (WIQ) distance score), and mobility (measured by the Patient-Reported Outcomes Measurement Information System \[PROMIS\] mobility questionnaire) at 12-month follow-up. Tertiary outcomes are perceived exertional effort (measured by the Borg scale at the end of the 6-minute walk at 12-month follow-up), and diet quality. Exploratory outcomes consist of change in the short physical performance battery (SPPB), the WIQ stair climbing and walking speed scores, and calf muscle biopsy measures at 12-month follow-up. Study investigators will perform calf muscle biopsies in 50 participants to compare changes in mitochondrial biogenesis and activity, capillary density, and inflammation between WL+EX vs. EX.
Is exercise and weight loss a promising treatment for obese PAD patients?Yes, exercise and weight loss are promising treatments for obese PAD patients. Exercise helps with weight loss, improves heart health, and can enhance quality of life. It also supports long-term weight maintenance and can prevent diseases like type 2 diabetes.168914
What safety data exists for exercise and weight loss treatments in obese PAD patients?The research indicates that combining exercise with behavioral weight loss programs is effective for weight loss and improving risk factors in obese patients with coronary heart disease (CHD). These interventions have shown improvements in insulin sensitivity, lipid profiles, blood pressure, and other metabolic syndrome components. Exercise programs, especially those that include both aerobic and resistance training, are recommended for weight loss and maintenance. Cardiac rehabilitation programs incorporating these strategies have demonstrated significant health benefits, suggesting that similar approaches could be safe and beneficial for obese PAD patients.3571112
What data supports the idea that Exercise and Weight Loss for Obese PAD Patients is an effective treatment?The available research shows that exercise and weight loss can be effective for obese patients. Physical activity helps with weight loss and maintaining weight loss, even if the weight loss itself is modest. It also improves fitness and reduces health risks, like heart disease and diabetes, regardless of weight changes. Combining high-intensity aerobic and resistance training is particularly effective in reducing belly fat and improving muscle strength. This makes exercise a valuable part of treatment for obesity, alongside other lifestyle changes.24101314
Do I need to stop my current medications to join the trial?The trial protocol does not specify whether you need to stop taking your current medications. However, based on the information provided, it seems that the focus is on exercise and diet, so you may not need to stop your medications. It's best to discuss this with the trial coordinators or your doctor.
Eligibility Criteria
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
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.
I am 18 years old or older.
I have been diagnosed with peripheral artery disease (PAD) based on tests or imaging.
I have been diagnosed with PAD based on specific index values.
I experience leg pain during exercise that stops after resting for 10 minutes.
You have peripheral artery disease (PAD), a body mass index (BMI) greater than 28 kg/m2, and are between the ages of 18 and 90. The diagnosis of PAD will be based on specific tests to measure blood flow in your legs, and if you have certain symptoms related to leg pain during physical activity.
I have peripheral artery disease (PAD).
Exclusion Criteria
My walking is limited due to a condition that is not peripheral artery disease.
I have had an amputation, suffer from severe limb ischemia, or am confined to a wheelchair.
My chest pain has gotten worse or I have chest pain even when resting.
I have not been treated for schizophrenia or psychosis in the last 6 months.
I have not had an eating disorder or weight loss treatment in the last 6 months.
I have had a heart attack or stroke in the last 3 months.
I have an ulcer on the bottom of my foot.
I haven't had major surgery or heart/leg vessel procedures in the last 3 months and don't plan any in the next year.
My weight has changed by more than 25 pounds in the last 6 months.
I do not have a severe illness like lung disease needing oxygen, life-threatening conditions, Parkinson's, or active cancer treatment.
My vision problems make it hard for me to walk.
Treatment Details
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Weight loss + exercise (WL+EX)Experimental Treatment2 Interventions
Weight loss + home based walking exercise (WL+EX)
Group II: Exercise alone (EX)Active Control1 Intervention
Home based walking exercise (EX)
Find a clinic near you
Research locations nearbySelect from list below to view details:
Johns Hopkins UniversityBaltimore, MD
Northwestern UniversityChicago, IL
Tulane UniversityNew Orleans, LA
University of MinnesotaMinneapolis, MN
More Trial Locations
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Who is running the clinical trial?
Northwestern UniversityLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
Wake Forest UniversityCollaborator
References
Use of personal trainers and financial incentives to increase exercise in a behavioral weight-loss program. [2022]Exercise is the best predictor of long-term weight loss. This study evaluated two strategies for improving exercise adherence and long-term weight loss in obese outpatients. Obese men and women (N = 193) were randomized to 1 of 5 treatment groups for 18 months: standard behavior therapy (SBT); SBT with supervised walks (SW) 3 times per week; SBT + SW with personal trainers (PT), who walked with participants, made phone reminders, and did make-up SW; SBT + SW with monetary incentives (I) for completing SW; and SBT + SW + PT + I. Both PT and I enhanced attendance at SWs, the combination producing the best adherence. Increased walk attendance did not result in higher overall energy expenditure, however, and long-term weight loss was also not improved. Post hoc analyses suggest that the level of exercise needed for successful long-term weight loss is much higher than that usually recommended in behavioral treatment programs.
The future of obesity reduction: beyond weight loss. [2021]Obesity increases the risk of morbidity and mortality and reduces quality of life independent of age, sex or ethnicity. Leading health authorities recommend weight loss as a primary treatment strategy for obesity reduction--weight loss goals range from 5% to 10% of initial body weight. Intentional weight loss in most adults is associated with a reduction in many of the health complications of obesity. Nonetheless, emerging evidence supports the notion that a lifestyle-modification program characterized by an increase in physical activity and a balanced diet can reduce obesity and the risk of obesity-related comorbid conditions despite minimal or no weight loss. The benefits of such an approach include appreciable reductions in abdominal obesity, visceral fat and cardiometabolic risk factors, and increases in both skeletal muscle mass and cardiorespiratory fitness. Individuals with obesity face a serious challenge if they are to attain even modest weight loss in today's obesogenic environment. Clinicians could encourage positive lifestyle changes in their patients by counseling them that obesity and its associated health risks can be reduced in response to an increase in physical activity with or without weight loss.
The treatment of obesity in cardiac rehabilitation. [2021]Obesity is an independent risk factor for the development of coronary heart disease (CHD). At entry into cardiac rehabilitation (CR), more than 80% of patients are overweight and more than 50% have the metabolic syndrome. Yet, CR programs do not generally include weight loss programs as a programmatic component and weight loss outcomes in CR have been abysmal. A recently published study outlines a template for weight reduction based on a combination of behavioral weight loss counseling and an approach to exercise that maximized exercise-related caloric expenditure. This approach to exercise optimally includes walking as the primary exercise modality and eventually requires almost daily longer-distance exercise to maximize caloric expenditure. In addition, lifestyle activities such as stair climbing and avoidance of energy-saving devices should be incorporated into the daily routine. Risk factor benefits of weight loss and exercise training in overweight CHD patients are broad and compelling. Improvements in insulin resistance, lipid profiles, blood pressure, clotting abnormalities, endothelial-dependent vasodilatory capacity, and measures of inflammation such as C-reactive protein have all been demonstrated. Cardiac rehabilitation/secondary prevention programs can no longer ignore the challenge of obesity management in CHD patients. Individual programs need to develop clinically effective and culturally sensitive approaches to weight control. Finally, multicenter randomized clinical trials of weight loss in CHD patients with assessment of long-term clinical outcomes need to be performed.
Obesity and physical activity. [2011]Physical activity seems to be an important component of lifestyle interventions for weight loss and maintenance. Although the effects of physical activity on weight loss may seem to be modest, there seems to be a dose-response relationship between physical activity and weight loss. Physical activity also seems to be a critically important behavior to promote long-term weight loss and the prevention of weight regain. The benefits of physical activity on weight loss are also observed in patients with severe obesity (BMI ≥ 35 kg/m²) and in patients who have undergone bariatric surgery. Moreover, independent of the effect of physical activity on body weight, engagement in physical activity that results in improved cardiorespiratory fitness can contribute to reductions in health risk in overweight and obese adults. Thus, progression of overweight and obese patients to an adequate dose of physical activity needs to be incorporated into clinical interventions for weight control.
Impact of an exercise program on adherence and fitness indicators. [2017]Adherence to exercise is one of the most problematic health behaviors. This pilot study describes the impact of an exercise program on adherence to exercise and fitness indicators for overweight and obese adults enrolled in an insurance reimbursed exercise plan. Chart reviews were conducted retrospectively in a convenience sample of 77 subjects from a human performance lab (HPL) at a large southern university. Charts from 2004 to 2009 were reviewed for health history, fitness indicators (fitness level, weight, BMI, hip/waist ratio, % body fat, BP, HR, cholesterol), and adherence (number of exercise sessions/month). Exercise supervision was operationalized in two phases over 12 months: Phase I (3 months supervised exercise) and Phase II (9 months unsupervised exercise). Fifty-eight participants completed Phase I, and 8 completed Phase II. Six-nine percent of those completing Phase I visited the gym at least 8 times/month with significant (α=.05) improvement in all fitness indicators. Those visiting
Feasibility and effect of in-home physical exercise training delivered via telehealth before bariatric surgery. [2018]Optimal physical activity (PA) interventions are needed to increase PA in individuals with severe obesity, and optimize the results of bariatric surgery (BS). The aim of this study was to assess the feasibility and effect of Pre-Surgical Exercise Training (PreSET) delivered in-home via telehealth (TelePreSET) in subjects awaiting BS. Six women following the TelePreSET were compared to the women from a previous study (12 performing the PreSET in a gymnasium and 11 receiving usual care). In-home TelePreSET (12-weeks of endurance and strength training) was supervised twice weekly using videoconferencing. Physical fitness, quality of life, exercise beliefs, anthropometric measures and telehealth perception were assessed before and after 12-weeks. Satisfaction was evaluated with questionnaires at the end of the intervention. The TelePreSET participants attended 96% of the exercise sessions, and were very satisfied by the TelePreSET. The baseline telehealth perception score was high, and increased significantly after the intervention. The TelePreSET group significantly increased their physical fitness compared to the usual care group. No significant change was noted in other outcomes. The TelePreSET is feasible and seems effective to improve the physical fitness of women awaiting BS. Further studies are needed to confirm beneficial effects of this innovative mode of delivery.
Obesity in coronary heart disease: An unaddressed behavioral risk factor. [2018]Obesity is an independent risk factor for the development and progression of coronary heart disease (CHD). Over 80% of patients with CHD are overweight or obese. While obesity is often considered a relatively "minor" CHD risk factor, weight loss is a broadly effective risk-factor intervention. Weight loss can profoundly influence a number of "major" risk factors including: hypertension, dyslipidemia and insulin resistance/type 2 diabetes mellitus. Despite its prominence as a risk factor most cardiac rehabilitation (CR) programs do not have a specific, targeted intervention to assist patients with weight loss. Consequently, the weight loss that occurs during CR is quite small and unlikely to appreciably alter risk factors. Relying on CR associated exercise as a sole intervention is an ineffective strategy to promote weight loss. There is evidence, however, that behavioral weight loss (BWL) interventions can be effectively employed in the CR setting. In contrast to programs that do not offer a targeted intervention, studies show that participants in CR-related BWL programs lose significantly more weight. The additional weight loss from the BWL intervention is associated with greater improvements in insulin sensitivity and other components of the metabolic syndrome such as hypertension and lipid abnormalities. As a means of maximizing CHD risk factor reduction CR programs need to incorporate BWL programs as a standard programming for overweight/obese patients.
Adaptaciones al ejercicio físico en el perfil lipídico y la salud cardiovascular de obesos mórbidos. [2022]To assess the effects of a physical exercise program on the lipid profile, weight status and the cardiovascular health of obese candidates for bariatric surgery.
Exercise and Bariatric Surgery: An Effective Therapeutic Strategy. [2018]The long-term efficacy of bariatric surgery is not entirely clear, and weight regain and diabetes relapse are problems for some patients. Exercise is a feasible and clinically effective adjunct therapy for bariatric surgery patients. We hypothesize that exercise is also a critical factor for long-term weight loss maintenance and lasting remission of type 2 diabetes.
What exercise prescription is optimal to improve body composition and cardiorespiratory fitness in adults living with obesity? A network meta-analysis. [2021]Current international guidelines recommend people living with obesity should be prescribed a minimum of 300 min of moderately intense activity per week for weight loss. However, the most efficacious exercise prescription to improve anthropometry, cardiorespiratory fitness (CRF) and metabolic health in this population remains unknown. Thus, this network meta-analysis was conducted to assess and rank comparative efficacy of different exercise interventions on anthropometry, CRF and other metabolic risk factors. Five electronic databases were searched for randomized controlled trials (RCTs) that compared different exercise modalities to improve anthropometry, CRF and/or metabolic health in adults living with obesity. RCTs were evaluated using the Cochrane risk of bias tool. A random effects network meta-analysis was performed within a frequentist framework. Of the 6663 articles retrieved, 45 studies with a total 3566 participants were included. Results reveal that while any type of exercise intervention is more effective than control, weight loss induced is modest. Interventions that combine high-intensity aerobic and high-load resistance training exert beneficial effects that are superior to any other exercise modality at decreasing abdominal adiposity, improving lean body mass and increasing CRF. Clinicians should consider this evidence when prescribing exercise for adults living with obesity, to ensure optimal effectiveness.
Obesity and physical exercise. [2021]Obesity represents a major health problem worldwide and is associated with increased prevalence of numerous health-related conditions, including diabetes, hypertension, cardiovascular disease, some forms of cancer and musculoskeletal disorders, among others. Studies that have examined the impact of physical exercise combined with energy restriction diets on weight have shown greater weight loss compared to interventions of exercise-only. Accordingly, the most effective approach to achieve significant weight loss includes a combination of diet, exercise and behavioral strategies. Current guidelines recommend participating in at least 150 minutes of moderate-intensity or 75 minutes of vigorous intensity aerobic exercise weekly, and resistance/muscle strengthening training, involving all major muscle groups at least twice a week. For patients seeking to maintain weight loss, high levels of exercise (225-420 min/week of moderate intensity exercise) have been associated with improved weight maintenance compared to lower levels (
Effect of a phase 2 cardiac rehabilitation program on obese and non-obese patients with stable coronary artery disease. [2021]Obesity is associated with significant cardiovascular morbidity and mortality effects. Cardiac rehabilitation programs cause a significant reduction in cardiovascular mortality and a reduction in all cardiovascular risk factors. Up to 80% of patients referred to cardiac rehabilitation programs are either overweight or obese. This study aimed to compare the effects of a phase 2 cardiac rehabilitation program on obese and non-obese patients with stable coronary artery disease following total revascularization by coronary angioplasty.
Prescribed exercise to Reduce Recidivism After Weight Loss-Pilot (PREVAIL-P): Design, methods and rationale. [2023]Clinically significant weight loss is associated with health benefits for overweight and obese adults. Participation in adequate amounts of physical activity is critical for weight maintenance. However, the recommended amount of physical activity needed to promote weight maintenance is based primarily on retrospective studies that quantified physical activity levels through questionnaires which tend to overestimate physical activity levels. In addition, the present literature has provided little data on the impact of these physical activity levels on cardiovascular and diabetes risk factors, which may have equal or more clinical importance than weight changes. The Prescribed Exercise to Reduce Recidivism After Weight Loss-Pilot (PREVAIL-P) study will evaluate the effect of aerobic exercise training amount on weight maintenance following clinically significant weight loss in overweight and obese adults (BMI 25-40 kg/m2) age 30-65 years. Participants (N = 39) will complete a 10-week OPTIFAST® weight loss program with supervised aerobic exercise training. Individuals who achieve ≥7% weight loss from baseline will be subsequently randomized to levels of aerobic training consistent with physical activity recommendations (PA-REC) or weight maintenance recommendations (WM-REC) for 18 additional weeks. The primary outcome of the PREVAIL-P study will be change in weight from the completion of OPTIFAST® program to the end of the study. Notable secondary measures include changes in clinically relevant cardiometabolic risk factors between study groups (e.g. blood lipids concentrations, oral glucose tolerance, arterial stiffness). This pilot study will be used to estimate the effect sizes needed for a randomized controlled trial on this topic.
Physical activity in management of persons with obesity. [2021]Physical activity and exercise have many benefits in persons with obesity, helping with weight loss, body fat loss, abdominal visceral fat loss and possibly with weight maintenance after weight loss. The effect of exercise training (endurance or endurance plus resistance or high-intensity interval training) alone on weight loss as outcome appears relatively modest, amounting to only a few kg. However, endurance training during weight loss has been shown to increase V̇O2max and resistance training during weight loss leads to lower loss in lean body mass and increased muscle strength. In addition, higher physical activity levels improve cardiovascular risk, whatever weight variations. Specifically, physical activity or exercise is part of lifestyle measures for prevention of type 2 diabetes and substantially helps with metabolic control in patients with type 2 diabetes. The importance of physical activity counselling and exercise prescription in the management strategy will depend on specific treatment objectives as defined for a given patient, including weight loss, prevention of weigh regain, prevention of cardio-metabolic comorbidities, lean body mass preservation but also improvement in quality of life or development of social links. The 5 A's strategy consisting in: Ask, Assess, Advise, Agree, Assist (or Arrange) appears well adapted in this setting. Professionals need to be aware of the many barriers patients with obesity may meet on their way to increase habitual physical activity as specific solutions should be proposed. A major challenge is how to improve adherence to new physical activity habits over time.