Promote Weight Loss in Obese Peripheral Artery Disease (PAD) Patients to Prevent Mobility Loss
NCT ID: NCT04228978
Last Updated: 2024-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
212 participants
INTERVENTIONAL
2020-03-01
2027-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Weight loss + exercise (WL+EX)
Weight loss + home based walking exercise (WL+EX)
Weight loss
Walking exercise combined with weight loss
Exercise
Walking exercise
Exercise alone (EX)
Home based walking exercise (EX)
Exercise
Walking exercise
Interventions
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Weight loss
Walking exercise combined with weight loss
Exercise
Walking exercise
Eligibility Criteria
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Exclusion Criteria
2. Walking is limited by a condition other than PAD.
3. Failure to complete the study run-in, defined as not entering at least 800 Kcal of consumed calories per day for at least five days during the 14-day run-in\*.
4. Major surgery, coronary or leg revascularization in the past 3 months or anticipated in the next year.
5. Experienced a heart attack or stroke in the past 3 months.
6. Major medical illness including lung disease requiring oxygen or life-threatening illness, Parkinson's disease, a life-threatening illness with life expectancy less than six months, or cancer requiring treatment in the previous two years. \[NOTE: potential participants may still qualify if they have had treatment for an early stage cancer in the past two years and the prognosis is excellent.
7. Mini-Mental Status Examination (MMSE) score \< 23, dementia and substance abuse. Potential participants with an MMSE score of less than 23 may be eligible if the principal investigator determines that their lower score is due to reasons other than poor cognition. Other potential reasons for lower scores include poor literacy or that English is not their first language.
8. History of being treated for new onset or an acute episode of schizophrenia or psychosis in the past 6 months.
9. Hospitalization for a psychiatric disorder in the past 6 months.
10. BMI \> 45 kg/m2
11. History of a significant eating disorder that has been active within the past 5 years or any weight loss treatment in the past 6 months. Weight loss treatment includes weight watchers, any history of weight loss surgery, and using weight loss medications now or in the past six months.
12. Weight gain or loss of more than 25 pounds in the past six months
13. Potential participants unwilling/unable to use a smart phone and unwilling to attend weekly study sessions.
14. Excessive alcohol use, defined as \>14 drinks/week in men and \> 10 alcoholic drinks/week in women.
15. Current ulcer on bottom of foot
16. Current participation in supervised treadmill exercise, participation in supervised treadmill exercise in the past three months, or planning to participate in supervised treadmill exercise in the next year
17. Increase in angina or angina at rest. Potential participants may become eligible following an abnormal baseline treadmill stress test if they have evidence of an absence of coronary ischemia based on testing with their own physician.
18. Non-English speaking
19. Visual impairment that limits walking ability
20. Currently walking regularly for exercise at a level comparable to the amount of exercise prescribed in the intervention
21. Participation in or completion of a clinical trial in the previous three months. \[NOTE: after completing a stem cell or gene therapy intervention, participants will become eligible after the final study follow-up visit of the stem cell or gene therapy study so long as at least six months have passed since the final intervention administration. After completing a supplement or drug therapy (other than stem cell or gene therapy), participants will be eligible after the final study follow-up visit as long as at least three months have passed since the final intervention of the trial.\]
22. In addition to the above criteria, investigator discretion will be used to determine if the trial is unsafe or not a good fit for the potential participant
* The run-in will also be used to assist participants with learning the app. However, they must demonstrate ability to enter at least 800 Kcal per day for at least five days of the run-in.
18 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Wake Forest University
OTHER
Northwestern University
OTHER
Responsible Party
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Mary McDermott
Jeremiah Stamler Professor
Principal Investigators
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Mary M McDermott, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Walter Ambrosius, PhD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University
Locations
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Northwestern University
Chicago, Illinois, United States
Tulane University
New Orleans, Louisiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
Henry Ford Health
Detroit, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Whipple MO, Pfammatter AF, Spring B, Rejeski WJ, Treat-Jacobson D, Domanchuk KJ, Dressler EV, Ferrucci L, Gildea L, Guralnik JM, Harvin L, Leeuwenburgh C, Polonsky TS, Reynolds E, Stowe CL, Sufit R, Van Horn L, Walkup MP, Ambrosius WT, McDermott MM. Study Design, Rationale, and Methodology for Promote Weight Loss in Patients With Peripheral Artery Disease Who Also Have Obesity: The PROVE Trial. J Am Heart Assoc. 2023 Sep 5;12(17):e031182. doi: 10.1161/JAHA.123.031182. Epub 2023 Aug 29.
Other Identifiers
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STU00209524
Identifier Type: -
Identifier Source: org_study_id
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