Improving Functioning in Peripheral Arterial Disease
2 other identifiers
interventional
156
1 country
1
Brief Summary
The purpose of this study is to compare the effects of nutrition, a supervised treadmill exercise program, and supervised progressive resistance training program on peripheral arterial disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable cardiovascular-diseases
Started Sep 2003
Longer than P75 for not_applicable cardiovascular-diseases
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 22, 2005
CompletedFirst Posted
Study publicly available on registry
March 23, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedJuly 25, 2012
July 1, 2012
4.8 years
March 22, 2005
July 24, 2012
Conditions
Outcome Measures
Primary Outcomes (2)
Six-minute walk distance
Measured at baseline and follow-up study visits
Summary performance score
Measured at baseline and follow-up study visits
Study Arms (3)
1
EXPERIMENTAL6-month supervised treadmill exercise program
2
EXPERIMENTAL6-month supervised lower extremity progressive resistance training program
3
ACTIVE COMPARATORDiet/nutrition control group
Interventions
Eligibility Criteria
You may qualify if:
- peripheral arterial disease patients with and without IC
You may not qualify if:
- Below or above-knee amputation
- Wheelchair confinement
- Inability to walk on a treadmill or inability to perform progressive resistance training
- Inability to return to the medical center three times weekly for 6 months
- Walking impairment due to a cause other than PAD
- Class II New York Heart Association (NYHA) heart failure or angina (heart failure or angina occurring at rest or with minimal exertion)
- Planned lower extremity revascularization or any other major surgery within 12 months
- Any increase in anginal symptoms during the previous 6 months or angina at rest
- Subjects with silent coronary ischemia, defined as ST segment depression greater than or equal to 1 mm during baseline exercise treadmill test without associated chest discomfort, unless they have had a normal perfusion stress test during the previous 6 months
- Subjects with left-bundle branch block or significant ST-T wave changes on their baseline ECG who do not have a perfusion stress test demonstrating absence of reversible ischemia within the previous 6 months
- Lower extremity revascularization, major orthopedic surgery, or other major surgery during the previous 3 months
- Myocardial infarction or coronary artery bypass grafting during the previous 3 months
- Major medical illnesses that may interfere with subject's ability to complete the interventions and/or follow-up testing
- Current foot ulcer
- ABI greater than 0.95
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611-3008, United States
Related Publications (8)
Hammond MM, Tian L, Zhao L, Zhang D, McDermott MM. Attendance at Supervised Exercise Sessions and Walking Outcomes in Peripheral Artery Disease: Results From 2 Randomized Clinical Trials. J Am Heart Assoc. 2022 Dec 20;11(24):e026136. doi: 10.1161/JAHA.122.026136. Epub 2022 Dec 19.
PMID: 36533626DERIVEDMcDermott MM, Tian L, Criqui MH, Ferrucci L, Greenland P, Guralnik JM, Kibbe MR, Li L, Sufit R, Zhao L, Polonsky TS. Perceived Versus Objective Change in Walking Ability in Peripheral Artery Disease: Results from 3 Randomized Clinical Trials of Exercise Therapy. J Am Heart Assoc. 2021 Jun 15;10(12):e017609. doi: 10.1161/JAHA.120.017609. Epub 2021 Jun 2.
PMID: 34075780DERIVEDPatel K, Polonsky TS, Kibbe MR, Guralnik JM, Tian L, Ferrucci L, Criqui MH, Sufit R, Leeuwenburgh C, Zhang D, Zhao L, McDermott MM. Clinical characteristics and response to supervised exercise therapy of people with lower extremity peripheral artery disease. J Vasc Surg. 2021 Feb;73(2):608-625. doi: 10.1016/j.jvs.2020.04.498. Epub 2020 May 19.
PMID: 32416309DERIVEDMcDermott MM, Kibbe MR, Guralnik JM, Ferrucci L, Criqui MH, Domanchuk K, Tian L, Zhao L, Li L, Patel K, Polonsky TS. Durability of Benefits From Supervised Treadmill Exercise in People With Peripheral Artery Disease. J Am Heart Assoc. 2019 Jan 8;8(1):e009380. doi: 10.1161/JAHA.118.009380.
PMID: 30587066DERIVEDMcDermott MM, Ferrucci L, Guralnik JM, Dyer AR, Liu K, Pearce WH, Clark E, Liao Y, Criqui MH. The ankle-brachial index is associated with the magnitude of impaired walking endurance among men and women with peripheral arterial disease. Vasc Med. 2010 Aug;15(4):251-7. doi: 10.1177/1358863X10365181. Epub 2010 May 28.
PMID: 20511294DERIVEDPayvandi L, Dyer A, McPherson D, Ades P, Stein J, Liu K, Ferrucci L, Criqui MH, Guralnik JM, Lloyd-Jones D, Kibbe MR, Liang ST, Kane B, Pearce WH, Verta M, McCarthy WJ, Schneider JR, Shroff A, McDermott MM. Physical activity during daily life and brachial artery flow-mediated dilation in peripheral arterial disease. Vasc Med. 2009 Aug;14(3):193-201. doi: 10.1177/1358863X08101018.
PMID: 19651668DERIVEDMcDermott MM, Ades P, Guralnik JM, Dyer A, Ferrucci L, Liu K, Nelson M, Lloyd-Jones D, Van Horn L, Garside D, Kibbe M, Domanchuk K, Stein JH, Liao Y, Tao H, Green D, Pearce WH, Schneider JR, McPherson D, Laing ST, McCarthy WJ, Shroff A, Criqui MH. Treadmill exercise and resistance training in patients with peripheral arterial disease with and without intermittent claudication: a randomized controlled trial. JAMA. 2009 Jan 14;301(2):165-74. doi: 10.1001/jama.2008.962.
PMID: 19141764DERIVEDMcDermott MM, Ades PA, Dyer A, Guralnik JM, Kibbe M, Criqui MH. Corridor-based functional performance measures correlate better with physical activity during daily life than treadmill measures in persons with peripheral arterial disease. J Vasc Surg. 2008 Nov;48(5):1231-7, 1237.e1. doi: 10.1016/j.jvs.2008.06.050. Epub 2008 Oct 1.
PMID: 18829215DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mary McDermott, MD
Northwestern University Feinberg School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 22, 2005
First Posted
March 23, 2005
Study Start
September 1, 2003
Primary Completion
July 1, 2008
Study Completion
March 1, 2009
Last Updated
July 25, 2012
Record last verified: 2012-07