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Patient Centered Home Exercise Program for Peripheral Artery Disease

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ClinicalTrials.gov Identifier: NCT02462824
Recruitment Status : Completed
First Posted : June 4, 2015
Last Update Posted : January 8, 2018
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Mary McDermott, Northwestern University

Brief Summary:
The purpose of this study is to determine the effects of a home-based exercise intervention on walking ability in people with peripheral artery disease. In 200 patients with peripheral artery disease (PAD), the investigators are conducting a randomized controlled trial to determine whether a patient-centered home-based exercise program improves walking ability, physical activity, mobility, pain, and social functioning, compared to a usual care group.

Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Behavioral: Home-based exercise intervention Not Applicable

Detailed Description:

Lower extremity peripheral artery disease (PAD) is a common and chronic condition that affects 8 million people in the United States. PAD patients have difficulty walking because cholesterol blockages in their leg arteries prevent adequate oxygen supply to leg muscles during that activity. PAD patients reduce their physical activity levels and slow their walking speed to avoid leg pain.

Few therapies are available to help PAD patients improve their walking limitations. Treadmill exercise programs that require three or more supervised exercise sessions per week at an exercise facility can help PAD patients walk with less pain. However, most people with PAD do not participate in supervised exercise programs because they are not paid for by medical insurance and the requirements are burdensome for the patients.

The investigators have engaged PAD patients and relevant stakeholders to develop a home-based exercise intervention that is tailored to the needs of the patients. Our home-based exercise intervention includes a Fitbit activity monitor and a coach who will telephone PAD participants at regularly scheduled intervals. PAD patients will use the Fitbit to help them monitor their exercise behavior. The coach will use well-established behavioral methods during the scheduled telephone calls to help PAD patients adhere to regular walking exercise.

The investigators will conduct a randomized controlled trial of 200 patients with PAD to determine whether our home-based walking exercise program significantly improves walking performance and other patient-centered outcomes at the nine-month follow-up, compared to usual care.

PAD patients selected the trial's outcome measures as those that best represent PAD patients' physical limitations. All outcomes are well-validated and accepted outcome measures. The primary outcome measure is the six-minute walk test, an objective measure of walking endurance. Secondary outcomes consist of the Walking Impairment Questionnaire and the PROMIS questionnaires that assess patient-perceived walking ability, mobility, pain, and social functioning.

If our home-based exercise intervention is successful, the intervention will have a substantial impact on the large and growing number of people disabled by PAD.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: HOme-based moNitORed Exercise for PAD: The HONOR Study
Study Start Date : April 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Home-based exercise intervention
PAD Participants randomized to the home-based exercise intervention will be asked to take part in walking exercise to determine whether a patient-centered home-based exercise program improves walking ability, mobility, pain, and social functioning.
Behavioral: Home-based exercise intervention
The home-based exercise intervention focuses on walking exercise and consists of two phases. Phase I (weeks 1-4) consists of four on-site visits to an exercise facility, where participants will meet the telephone coach, learn to use the Fitbit activity monitor, become familiar with the study website, learn behavioral skills necessary for long-term adherence to home-based exercise, and get started on their exercise program. Phase II (weeks 5-36) is entirely home-based and includes a) use of the Fitbit for self-monitoring; and b) regularly scheduled telephone calls from the study telephone coach to monitor and support participants' home exercise activity' c) use of the study website; d) optional group telephone calls.

No Intervention: Usual care group
PAD participants randomized to usual care will not receive any study interventions. Rather, they will receive usual care from their own physicians.



Primary Outcome Measures :
  1. Change in Six-Minute Walk Performance at 9-month follow-up [ Time Frame: change from baseline to month 9 ]
    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. Change in Walking Impairment Questionnaire (WIQ) distance and speed and stair-climbing scores between baseline and nine-month follow-up [ Time Frame: change from baseline to month 9 follow-up ]
    The WIQ is a well validated questionnaire that measures patient-reported walking limitations in distance and speed.

  2. Patient-Reported Outcomes Measurement Information System (PROMIS) Questionnaires [ Time Frame: change from baseline to month 9 follow-up ]
    PROMIS Physical Function, PROMIS Pain Interference and PROMIS Ability to Participate in Social Roles and Activities questionnaires will be used to assess patient-reported health status for physical, mental, and social well-being.

  3. Short-Form 36 (SF-36) physical functioning score [ Time Frame: change from baseline to month 9 follow-up ]
    The SF-36 physical functioning score is a well-validated quality of life measure frequently used to assess changes in response to therapeutic interventions in patients with PAD.

  4. Actigraph-measured physical activity. [ Time Frame: change in physical activity from baseline to 9 month follow-up ]
    The Actigraph will be used to measure physical activity.


Other Outcome Measures:
  1. Change in Six-Minute Walk Performance at 4.5-month follow-up [ Time Frame: change from baseline to month 4.5 follow-up ]
    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. Change in Walking Impairment Questionnaire (WIQ) distance and speed and stair-climbing scores between baseline and 4.5 month follow-up [ Time Frame: change from baseline to month 4.5 follow-up ]
    The WIQ is a well validated questionnaire that measures patient-reported walking limitations in distance and speed.

  3. Patient-Reported Outcomes Measurement Information System (PROMIS) Questionnaires [ Time Frame: change from baseline to month 4.5 follow-up ]
    PROMIS Physical Function, PROMIS Pain Interference and PROMIS Ability to Participate in Social Roles and Activities questionnaires will be used to assess patient-reported health status for physical, mental, and social well-being.

  4. Short-Form 36 (SF-36) physical functioning score [ Time Frame: change from baseline to month 4.5 follow-up ]
    The SF-36 physical functioning score is a well-validated quality of life measure frequently used to assess changes in response to therapeutic interventions in patients with PAD.

  5. Actigraph-measured physical activity. [ Time Frame: change in physical activity from baseline to 4.5 month follow-up ]
    The Actigraph will be used to measure physical activity.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participants with an ankle brachial index (ABI) ≤ 0.90 will be eligible for participation.
  2. Participants with an ABI > 0.90 but ≤ 1.00 who experience a 20% drop in ankle pressure after the heel-rise exercise will be eligible.
  3. Participants with an ABI > 0.90 who have medical record evidence of prior lower extremity revascularization for PAD will be eligible
  4. Participants with an ABI > 0.90 who have medical record evidence of PAD based on non-invasive vascular laboratory testing or based on angiographic findings will be eligible. Non-invasive vascular laboratory evidence of PAD must be obtained from a vascular laboratory.

Exclusion Criteria:

  1. Above or below knee amputation, critical limb ischemia, wheelchair confinement, foot ulcer, non-English speaking, significant visual impairment that interferes with walking activity, hearing impairment that interferes with full study participation, unable to return to the medical center or fitness center at the expected visit frequency, or unwilling to use technology required for the intervention.
  2. Individuals whose walking is limited by a condition other than PAD.
  3. Greater than class II NYHA heart failure or angina. Increase in angina, angina at rest, abnormal baseline stress test.
  4. Major surgery including lower extremity revascularization or orthopedic surgery during the prior three months or anticipated in the next nine months.
  5. Major medical illness including lung disease requiring oxygen, Parkinson's disease that impairs walking ability, or cancer requiring treatment in the prior two years (potential participants may still qualify if they were diagnosed with non-melanoma skin cancer in the past two years or if they have had treatment for an early stage cancer in the past two years and the prognosis is excellent).
  6. Heart attack, stroke, or coronary artery bypass surgery in the last 3 months.
  7. Mini-mental status examination score < 23, dementia, or psychiatric illness.
  8. Currently walking regularly for exercise at a level comparable to the amount of exercise prescribed in the intervention
  9. Currently enrolled in another clinical trial, exercise trial, or in cardiac rehabilitation. Currently enrolled in a clinical trial or current participation in cardiac rehabilitation or a trial of a therapeutic intervention within the past three months. For a clinical trial of a stem cell or gene therapy intervention, potential participants will be potentially eligible immediately after the final study visit for the clinical trial, so long as s at least six months has passed since the participant received their final treatment in the stem cell or gene therapy study .
  10. Deemed a poor candidate for the study or poorly suited for the intervention (at PI discretion).

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): NCT02462824


Locations
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United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611-3008
Northwestern University feinberg School of Medicine
Chicago, Illinois, United States, 60611
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
Northwestern University
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Mary McDermott, MD Northwestern University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mary McDermott, Jeremiah Stamler Professor in Medicine-General Internal Medicine and Geriatrics and Preventive Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT02462824     History of Changes
Other Study ID Numbers: STU00100697
First Posted: June 4, 2015    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: January 2018

Keywords provided by Mary McDermott, Northwestern University:
Peripheral Artery Disease
Peripheral Arterial Disease
PAD

Additional relevant MeSH terms:
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Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases