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Physical Activity Daily - An Internet-Based Walking Program for Patients With Peripheral Arterial Disease

NCT ID: NCT02022423

Last Updated: 2021-12-21

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2021-12-31

Brief Summary

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Peripheral arterial disease (PAD) is a significant vascular condition affecting millions of adults. Exercise such as walking is highly effective for reducing PAD symptoms such as claudication (pain with walking) and improving physical function. The trial examines the efficacy of a internet-delivered walking program for patients with PAD. Comparator groups including telephone counselling, the combination of internet-delivered walking program + telephone counseling, or usual care. The primary outcome of interest is maximal walking distance.

Detailed Description

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With the aging of the American population, the numbers of adults with peripheral arterial disease (PAD) will increase significantly over the next several decades. Patients with PAD are at increased risk for morbidity and mortality including both cardiovascular and all-cause mortality. While regular physical activity reduces risk for vascular events and is recommended for treatment of PAD patients, few patients meet recommended goals. Exercise programs which increase long-term adherence to walking can be an important contribution to PAD treatment. Our Internet-based intervention, builds on a walking enhancement program developed by members of our team and is shown to improve adherence among patients with vascular disease such as coronary artery disease (CAD). Using a randomized, controlled trial study design, we propose to test an automated Internet-based walking program to improve long-term adherence to walking while increasing walking distance, and health-related quality of life, among patients with PAD. Participants will be randomized to 1 of four study groups: 1) weekly telephone counseling, 2) an Internet-based walking program, 3) a combination of telephone counseling and Internet-based walking program, or 4) a usual care group. The Internet-based walking program has been shown to increase both adherence to walking and overall walking duration in populations with chronic complex conditions such as CAD and diabetes. There is a strong need to develop interventions, easily generalizable to a real-world population, to improve the reach of lifestyle interventions which result in improved physical function and adherence to regular exercise among complex medical patients. Patients such as those with PAD (a CAD risk equivalent) stand to benefit the most from such programs.

Conditions

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Peripheral Arterial Disease

Keywords

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peripheral arterial disease walking eHealth telehealth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Four groups are included in this study
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Telephone Counseling

Weekly telephone calls to assess compliance to exercise prescription and discuss various topics related to adoption and adherence to walking programs

Group Type ACTIVE_COMPARATOR

Telephone counseling

Intervention Type BEHAVIORAL

4 months of weekly contact to update exercise prescription and discuss barriers and challenges to adherence

Internet-based walking program

Weekly automated goals are delivered via email to subject; goals are based on previous week's step count accumulation.

Group Type EXPERIMENTAL

Internet-based walking program

Intervention Type BEHAVIORAL

Four-month Internet-based walking program consisting of weekly step count goals

Telephone counseling and Internet-based walking program

Weekly telephone calls to assess compliance to exercise prescription and discuss various topics related to adoption and adherence to walking programs plus weekly automated goals are delivered via email to subject; goals are based on previous week's step count accumulation.

Group Type EXPERIMENTAL

Telephone counseling

Intervention Type BEHAVIORAL

4 months of weekly contact to update exercise prescription and discuss barriers and challenges to adherence

Internet-based walking program

Intervention Type BEHAVIORAL

Four-month Internet-based walking program consisting of weekly step count goals

Usual Care

Subjects will continue with their health care as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Telephone counseling

4 months of weekly contact to update exercise prescription and discuss barriers and challenges to adherence

Intervention Type BEHAVIORAL

Internet-based walking program

Four-month Internet-based walking program consisting of weekly step count goals

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Age ≥ 40

Diagnosis of PAD due to atherosclerosis, documented by 1 or more of the following:

* documented ankle brachial index (ABI) ≤ 0.9 in at least one leg
* toe brachial index ≤ .70 for participants with an ABI \> 1.3
* documented arterial disease by MRI, CT or angiogram Ability to walk at least 150 feet without the assistance of a cane or walker. Are sedentary (defined as \< 150 minutes per week of physical activity). Able to obtain medical clearance from a primary care provider, cardiologist, vascular specialist, endocrinologist, nurse practitioner, or physician assistant.

Competent to give informed consent. Have regular access to a computer with an Internet connection that allows software downloading.

Be a regular email user (check email at least once a week).

Exclusion Criteria

PAD due to non-atherosclerotic causes such as trauma, entrapment syndromes or congenital anomalies.

No primary provider, or cardiologist or vascular provider Life expectancy of under 1-year Co-morbidities which limit physical activity to a severe degree (defined as the inability to walk a grocery store aisle unassisted) Signs of critical limb ischemia and/or planned peripheral revascularization in the next 12-months

A diagnoses of any of the following cardiovascular events in the past 3 months:

* stroke/transient ischemic attack
* myocardial infarction
* unstable angina
* percutaneous coronary intervention
* coronary bypass graft surgery A diagnoses of any of the following cardiovascular conditions
* severe valve disease untreated
* complex arrhythmia untreated
* New York Heart Association class III-IV heart failure Current substance abuse, or significant psychiatric disorder, or dementia which limits the participant's ability to follow the study protocol Pregnancy Non-English speaking
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth Anne Jackson

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elizabeth A. Jackson, MD MPH FACC

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingahm

Locations

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University of Alabama Birmingham

Birmingham, Alabama, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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Kumar AM, Lyden AK, Carlozzi NE, Sen A, Richardson CR, Jackson EA. The Physical Activity Daily (PAD) Trial: The rationale and design of a randomized controlled trial evaluating an internet walking program to improve maximal walking distance among patients with peripheral arterial disease. Contemp Clin Trials. 2018 Apr;67:23-30. doi: 10.1016/j.cct.2017.12.009. Epub 2017 Dec 21.

Reference Type BACKGROUND
PMID: 29274894 (View on PubMed)

Jones R, Enogela EM, Zumbro EL, Soukhamneut P, Richardson CR, Buford TW, Jackson EA. Assessment of Frailty Among Older Adults in the Physical Activity Daily Trial. J Appl Gerontol. 2024 Oct;43(10):1428-1437. doi: 10.1177/07334648241244690. Epub 2024 Apr 24.

Reference Type DERIVED
PMID: 38655762 (View on PubMed)

Other Identifiers

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NCT02022423

Identifier Type: -

Identifier Source: org_study_id