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Exercise and Weight Loss for Obese PAD Patients (PROVE Trial)

N/A
Recruiting
Led By Mary M McDermott, MD
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
Must not have
Walking limited by a condition other than PAD
Above or below knee amputation, critical limb ischemia, or wheelchair confinement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 months
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have PAD, confirmed by specific leg blood flow tests showing changes after exercise.
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I had surgery to improve blood flow in my legs due to PAD symptoms.
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I am 18 years old or older.
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I have been diagnosed with peripheral artery disease (PAD) based on tests or imaging.
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I have been diagnosed with PAD based on specific index values.
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I experience leg pain during exercise that stops after resting for 10 minutes.
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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).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My walking is limited due to a condition that is not peripheral artery disease.
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I have had an amputation, suffer from severe limb ischemia, or am confined to a wheelchair.
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My chest pain has gotten worse or I have chest pain even when resting.
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I have not been treated for schizophrenia or psychosis in the last 6 months.
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I have not had an eating disorder or weight loss treatment in the last 6 months.
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I have had a heart attack or stroke in the last 3 months.
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I have an ulcer on the bottom of my foot.
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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.
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My weight has changed by more than 25 pounds in the last 6 months.
Select...
I do not have a severe illness like lung disease needing oxygen, life-threatening conditions, Parkinson's, or active cancer treatment.
Select...
My vision problems make it hard for me to walk.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
12-month change in six-minute walk distance
Secondary study objectives
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 more
Other study objectives
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 more

Side effects data

From 2016 Phase 3 trial • 150 Patients • NCT00856609
98%
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Weight loss
2010
Completed Phase 4
~1790
Exercise
2016
Completed Phase 1
~820

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,943 Previous Clinical Trials
47,797,721 Total Patients Enrolled
53 Trials studying Peripheral Arterial Disease
108,870 Patients Enrolled for Peripheral Arterial Disease
Northwestern UniversityLead Sponsor
1,652 Previous Clinical Trials
961,303 Total Patients Enrolled
28 Trials studying Peripheral Arterial Disease
4,862 Patients Enrolled for Peripheral Arterial Disease
Wake Forest UniversityOTHER
192 Previous Clinical Trials
166,024 Total Patients Enrolled
1 Trials studying Peripheral Arterial Disease
28 Patients Enrolled for Peripheral Arterial Disease
Mary M McDermott, MDPrincipal InvestigatorNorthwestern University
4 Previous Clinical Trials
961 Total Patients Enrolled
4 Trials studying Peripheral Arterial Disease
961 Patients Enrolled for Peripheral Arterial Disease
Walter Ambrosius, PhDPrincipal InvestigatorWake Forest University
1 Previous Clinical Trials
289 Total Patients Enrolled

Media Library

Exercise Clinical Trial Eligibility Overview. Trial Name: NCT04228978 — N/A
Peripheral Arterial Disease Research Study Groups: Weight loss + exercise (WL+EX), Exercise alone (EX)
Peripheral Arterial Disease Clinical Trial 2023: Exercise Highlights & Side Effects. Trial Name: NCT04228978 — N/A
Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT04228978 — N/A
Peripheral Arterial Disease Patient Testimony for trial: Trial Name: NCT04228978 — N/A
~66 spots leftby Feb 2027
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