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Exercise and Weight Loss for Obese PAD Patients (PROVE Trial)
N/A
Recruiting
Led By Walter Ambrosius, PhD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of PAD based on ABI of > 0.90 and <= 1.00 with a 20% or greater drop in ABI after the heel-rise test
History of lower extremity revascularization with symptomatic PAD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 months
Awards & highlights
PROVE Trial Summary
This trial will test whether a weight loss intervention combined with walking exercise is more effective than walking exercise alone in people with PAD and BMI > 28 kg/m2. The primary outcome is change in six-minute walk distance at 12-month follow-up.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include typical exercise-related issues such as muscle soreness or strain. Diet changes might cause digestive discomfort initially as the body adjusts to new eating habits.
PROVE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have PAD, confirmed by specific leg blood flow tests showing changes after exercise.
Select...
I had surgery to improve blood flow in my legs due to PAD symptoms.
Select...
I am 18 years old or older.
Select...
I have been diagnosed with peripheral artery disease (PAD) based on tests or imaging.
Select...
I have been diagnosed with PAD based on specific index values.
Select...
I experience leg pain during exercise that stops after resting for 10 minutes.
Select...
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.
Select...
I have peripheral artery disease (PAD).
PROVE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
12-month change in six-minute walk distance
Secondary outcome measures
12-month change in Patient-Reported Outcomes Measurement Information System (PROMIS) mobility questionnaire
12-month change in Walking Impairment Questionnaire (WIQ) distance score
12-month change in minutes of walking exercise/week
+2 moreOther outcome measures
12-month change in calf muscle biopsy measured COX enzyme activity
12-month change in calf muscle inflammation (IL-6, TNF-α, and IL1β)
12-month change in capillary density (capillaries per muscle fiber)
+6 moreSide effects data
From 2016 Phase 3 trial • 150 Patients • NCT0085660998%
hunger decrease
60%
Nausea
57%
Headache
40%
Diarrhea
35%
Constipation
33%
Injection site reaction
33%
Gastroesophageal reflux
30%
Itchiness
28%
Vomiting
25%
hypoglycemia
15%
Skin rash
10%
Palpitations
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Exenatide
PROVE Trial Design
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)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise
2016
Completed Phase 1
~760
Weight loss
2010
Completed Phase 4
~1790
Find a Location
Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,848 Previous Clinical Trials
47,818,050 Total Patients Enrolled
252 Trials studying Obesity
206,007 Patients Enrolled for Obesity
Northwestern UniversityLead Sponsor
1,601 Previous Clinical Trials
915,447 Total Patients Enrolled
33 Trials studying Obesity
11,332 Patients Enrolled for Obesity
Wake Forest UniversityOTHER
190 Previous Clinical Trials
164,388 Total Patients Enrolled
6 Trials studying Obesity
809 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You drink too much alcohol.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.You are currently doing or planning to do supervised treadmill exercise.You are currently exercising at a similar level to the exercise recommended in the study.Your body mass index (BMI) is higher than 25.My chest pain has gotten worse or I have chest pain even when resting.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.You weigh more than the recommended amount for your height.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 am 18 years old or older.I have been diagnosed with peripheral artery disease (PAD) based on tests or imaging.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.You were in the hospital for a mental health problem in the last 6 months.My weight has changed by more than 25 pounds in the last 6 months.I have been diagnosed with PAD based on specific index values.I do not have a severe illness like lung disease needing oxygen, life-threatening conditions, Parkinson's, or active cancer treatment.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).You have difficulty remembering things, have dementia, or have problems with substance abuse.You have a very high body weight for your height.My vision problems make it hard for me to walk.
Research Study Groups:
This trial has the following groups:- Group 1: Weight loss + exercise (WL+EX)
- Group 2: Exercise alone (EX)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Obesity Patient Testimony for trial: Trial Name: NCT04228978 — N/A
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