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Exercise and Weight Loss for Obese PAD Patients (PROVE Trial)
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.
PROVE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPROVE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2016 Phase 3 trial • 150 Patients • NCT00856609PROVE Trial Design
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- 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.You have a body mass index (BMI) higher than 25.I have peripheral artery disease (PAD).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.
- Group 1: Weight loss + exercise (WL+EX)
- Group 2: Exercise alone (EX)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
What are the criteria to qualify for participating in this trial?
"This trial is recruiting 212 people suffering from peripheral arterial disease (PAD) aged between 18 and 89. To be eligible, candidates must meet the following criteria: a BMI of more than 28 kg/m2; an ankle-brachial index below 0.90 or a toe brachial index below 0.70 after heel rise test with 20% drop in ABI; prior vascular laboratory evidence such as objective indications of PAD including TBI at <0.7, Duplex measure showing 70% stenosis or higher, post heel-rise ABI decrease of 20%; angiographic proof of PAD consisting a"
Are there opportunities for participants to join this trial?
"Affirmative. The information posted on clinicaltrials.gov reveals that this medical trial, which was first announced on March 1st 2020, is still actively recruiting participants. To date 212 patients have been sought from a single site."
Is the minimum age for enrolment in this trial set at 25 or higher?
"According to the specified rules, only individuals aged 18 to 89 may join this trial. There are 80 opportunities for minors and 550 openings for seniors above 65 years old."
What is the total number of participants in this experiment?
"Yes, according to the information on clinicaltrials.gov this trial is actively recruiting patients. It was initially posted on March 1st 2020 and last updated February 17th 2022, with a total of 212 participants needed from one site."
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