Patient Centered Home Exercise Program for Peripheral Artery Disease

NCT02462824 | Completed DMC

• 1 other identifier: STU00100697
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

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.

Conditions

Peripheral Artery Disease

Keywords

Peripheral Artery Disease; Peripheral Arterial Disease; PAD

Outcome Measures

Primary Outcomes (1)

• Change in Six-Minute Walk Performance at 9-month 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.

  change from baseline to month 9

Secondary Outcomes (4)

• Change in Walking Impairment Questionnaire (WIQ) distance and speed and stair-climbing scores between baseline and nine-month follow-up

  change from baseline to month 9 follow-up

• Patient-Reported Outcomes Measurement Information System (PROMIS) Questionnaires

  change from baseline to month 9 follow-up

• Short-Form 36 (SF-36) physical functioning score

  change from baseline to month 9 follow-up

• Actigraph-measured physical activity.

  change in physical activity from baseline to 9 month follow-up

Other Outcomes (5)

• Change in Six-Minute Walk Performance at 4.5-month follow-up

  change from baseline to month 4.5 follow-up

• Change in Walking Impairment Questionnaire (WIQ) distance and speed and stair-climbing scores between baseline and 4.5 month follow-up

  change from baseline to month 4.5 follow-up

• Patient-Reported Outcomes Measurement Information System (PROMIS) Questionnaires

  change from baseline to month 4.5 follow-up

Study Arms (2)

Home-based exercise intervention

EXPERIMENTAL

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

Usual care group

NO INTERVENTION

PAD participants randomized to usual care will not receive any study interventions. Rather, they will receive usual care from their own physicians.

Interventions

Home-based exercise intervention BEHAVIORAL

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.

Home-based exercise intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with an ankle brachial index (ABI) ≤ 0.90 will be eligible for participation.
• 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.
• Participants with an ABI \> 0.90 who have medical record evidence of prior lower extremity revascularization for PAD will be eligible
• 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.

You may not qualify if:

• 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.
• Individuals whose walking is limited by a condition other than PAD.
• Greater than class II NYHA heart failure or angina. Increase in angina, angina at rest, abnormal baseline stress test.
• Major surgery including lower extremity revascularization or orthopedic surgery during the prior three months or anticipated in the next nine months.
• 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).
• Heart attack, stroke, or coronary artery bypass surgery in the last 3 months.
• Mini-mental status examination score \< 23, dementia, or psychiatric illness.
• Currently walking regularly for exercise at a level comparable to the amount of exercise prescribed in the intervention
• 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 .
• Deemed a poor candidate for the study or poorly suited for the intervention (at PI discretion).

Sponsors & Collaborators

• Northwestern University: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (4)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611-3008, United States

Location

Northwestern University feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

New York University School of Medicine

New York, New York, 10016, United States

Location

Related Publications (1)

• McDermott MM, Spring B, Berger JS, Treat-Jacobson D, Conte MS, Creager MA, Criqui MH, Ferrucci L, Gornik HL, Guralnik JM, Hahn EA, Henke P, Kibbe MR, Kohlman-Trighoff D, Li L, Lloyd-Jones D, McCarthy W, Polonsky TS, Skelly C, Tian L, Zhao L, Zhang D, Rejeski WJ. Effect of a Home-Based Exercise Intervention of Wearable Technology and Telephone Coaching on Walking Performance in Peripheral Artery Disease: The HONOR Randomized Clinical Trial. JAMA. 2018 Apr 24;319(16):1665-1676. doi: 10.1001/jama.2018.3275.

  PMID: 29710165 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Mary McDermott, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

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: Jeremiah Stamler Professor in Medicine-General Internal Medicine and Geriatrics and Preventive Medicine

Study Record Dates

• First Submitted: May 4, 2015
• First Posted: June 4, 2015
• Study Start: April 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 8, 2018

Record last verified: 2018-01

Locations

US (4)