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Low InTensity Exercise Intervention in PAD (LITE)

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ClinicalTrials.gov Identifier: NCT02538900
Recruitment Status : Recruiting
First Posted : September 2, 2015
Last Update Posted : April 24, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Mary McDermott, Northwestern University

Brief Summary:
This proposed study will determine whether an exercise intervention that avoids continuous supervision and exercise-related ischemic pain improves walking performance at 52-week follow-up in people with PAD. Our intervention directly addresses two aspects of current practice guidelines that are major barriers to exercise for patients with PAD: 1) the recommendation for supervised exercise and 2) the recommendation for high intensity ischemic-pain inducing walking exercise.

Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Behavioral: Exercise Other: Attention control Not Applicable

Detailed Description:
We will randomize 305 PAD participants to one of three parallel arms: Group 1: Low-intensity, self-paced walking exercise; Group 2: Standard high intensity, ischemic pain-inducing walking exercise; Group 3: Non-exercising attention control group. The low and high intensity exercise groups will attend center-based exercise sessions once per week for four weeks followed by transition to an entirely home-based exercise program for an additional 48 weeks (52 weeks total). The low and high intensity exercise interventions will use identical self-regulatory and support strategies. However, the low intensity exercise group will be instructed to exercise with minimal to no ischemic leg discomfort and the high intensity group will be instructed to exercise to maximal ischemic leg pain. These two distinct exercise prescriptions will be reinforced during 48 weeks of home-based exercise, using a well-validated behavioral coaching model that can be delivered by telephone once weekly. Our primary outcome is change in six-minute walk distance at 52-week follow-up. If our hypotheses are correct, millions of people with PAD will benefit from this alternative exercise regimen which will be accessible to most of the 8 million people in the U.S. who suffer from PAD.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 305 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Low InTensity Exercise Intervention in PAD
Study Start Date : June 2015
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1
Low-intensity, self-paced walking exercise
Behavioral: Exercise
Participants in one of the exercise intervention groups will attend once weekly sessions at the medical center for the first four weeks of the study (Weeks 1-4, Phase I). During weeks 5-52 (Phase II), they will receive weekly telephone calls from a study coach.

Experimental: Group 2
Standard high intensity, ischemic pain-inducing walking exercise
Behavioral: Exercise
Participants in one of the exercise intervention groups will attend once weekly sessions at the medical center for the first four weeks of the study (Weeks 1-4, Phase I). During weeks 5-52 (Phase II), they will receive weekly telephone calls from a study coach.

Active Comparator: Group 3
Non-exercising attention control group
Other: Attention control
Our attention control group controls for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention. Participants randomized to the control group will attend weekly one-hour educational sessions at Northwestern University for the first four weeks of the intervention (Phase I). These sessions are on topics of interest to the typical PAD patient and are led by physicians and other health care workers. Topics include Medicare Part D, nutritional supplements, and cancer screening. During Phase II (weeks 5-52), the attention control group will receive weekly telephone calls, lasting 5-15 minutes, with information on a health-related topic.




Primary Outcome Measures :
  1. Six-minute walk distance [ Time Frame: change from baseline to week 52 ]
    In the six-minute walk, participants walk back and forth along a 100-ft hallway for six minutes after standardized instructions to complete as many laps as possible. Distance covered in six minutes is recorded.


Secondary Outcome Measures :
  1. Six-minute walk distance [ Time Frame: change from baseline to week 26 ]
    In the six-minute walk, participants walk back and forth along a 100-ft hallway for six minutes after standardized instructions to complete as many laps as possible. Distance covered in six minutes is recorded.

  2. Maximal treadmill walking time [ Time Frame: change from baseline to week 52 ]
    In the treadmill walking test, participants walk on either a gardner or modified gardner protocol until they stop the test. Time walked is recorded

  3. Physical activity levels [ Time Frame: Change from baseline to week 52 ]
    ActiGraph measured physical activity

  4. Walking Impairment Questionnaire (WIQ) distance and speed score. [ Time Frame: change from baseline to week 52 ]
    The WIQ is a well validated questionnaire that measures patient-reported walking limitations in distance and speed.

  5. Health-related quality of life measure [ Time Frame: change from baseline to week 52 ]
    The SF-36 physical functioning score will be used to measure quality of life.

  6. Adherence to intervention [ Time Frame: from baseline to week 52 ]
    Adherence is defined as the proportion achieving at least 80% of the prescribed exercise frequency and duration during the final month of the intervention.

  7. Change in muscle biopsy measures of mitochondrial oxidative metabolism and oxidative stress. [ Time Frame: change from baseline to week 52 ]
    Muscle tissue will be collected at baseline and follow up to measures Change in muscle biopsy measures of mitochondrial oxidative metabolism and oxidative stress.


Other Outcome Measures:
  1. Qualitative assessment [ Time Frame: At 52 week follow up ]
    We will use qualitative methods to explore participants' perceptions of the exercise interventions in the high and low-intensity exercise groups, respectively.

  2. Physical activity levels over seven days [ Time Frame: 26 week follow-up. ]
    ActiGraph

  3. WIQ distance and speed score [ Time Frame: 26 week follow-up ]
    The WIQ is a well validated questionnaire that measures patient-reported walking limitations in distance and speed.

  4. Health related quality of life [ Time Frame: 26 weeks ]
    SF-36 physical functioning score.

  5. Adherence to assigned intervention [ Time Frame: 26 weeks. ]
    Adherence is defined as the proportion achieving at least 80% of the prescribed exercise frequency and duration during the final month of the intervention.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. An ABI < or = 0.90 is a well accepted standard for the diagnosis of PAD and will be our inclusion criterion
  2. People with an ABI of 0.91-1.00 who experience a 20 % ankle systolic pressure drop after the heel-rise test will also be included.

Exclusion Criteria:

  1. Above or below knee amputation, critical limb ischemia, wheelchair confinement, or foot ulcer.
  2. Individuals whose walking is limited by a condition other than PAD.
  3. > Class II NYHA heart failure or angina. Increase in angina, angina at rest, or abnormal baseline treadmill stress test.
  4. Major surgery including lower extremity revascularization or orthopedic surgery during the prior three months or anticipated in the next twelve months.
  5. Major medical illness including renal disease requiring dialysis, lung disease requiring oxygen, or cancer requiring treatment in the prior three years.
  6. Mini-mental status examination score <23 (61), dementia, or psychiatric illness including severe depression or anxiety.
  7. Currently walking regularly for exercise.
  8. Current or recent (within 3 months) participation in another clinical trial or cardiac rehabilitation.
  9. Current or recent participation in a stem cell or gene therapy clinical trial where the final intervention administration is within 6 months screening.
  10. Chronic pain syndrome requiring narcotics.
  11. Individuals with PAD, a prior history of lower extremity revascularization and have a normal ABI.
  12. Individuals who are not able to walk at 1.0 MPH on a treadmill for two minutes.
  13. Individuals with PAD who do not experience exertional leg symptoms during both the six minute walk and the treadmill stress test. To be included, participants must experience leg symptoms during either the six minute walk or the treadmill stress test.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02538900


Contacts
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Contact: Anna Tanaglia, MA 312-503-5226 anna.tanaglia@northwestern.edu

Locations
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United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Mary McDermott    312-503-6419    mdm608@northwestern.edu   
United States, Louisiana
Ochsner Baptist Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Lydia Bazzano, MD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Diane Treat-Jacobson, PhD         
United States, Pennsylvania
University of Pittsburgh Medical Center Completed
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Northwestern University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Mary McDermott, MD Northwestern University

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Responsible Party: Mary McDermott, Professor of Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT02538900     History of Changes
Other Study ID Numbers: STU00105855
1R01HL122846-01 ( U.S. NIH Grant/Contract )
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Keywords provided by Mary McDermott, Northwestern University:
peripheral arterial disease, peripheral artery disease, PAD, exercise
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases