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

NCT02022423 | Completed

• 1 other identifier: NCT02022423
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Peripheral Arterial Disease

Keywords

peripheral arterial disease; walking; eHealth; telehealth

Outcome Measures

Primary Outcomes (4)

• Change in maximal walking distance

  measured using the Gardner-Skinner protocol treadmill test, noting time to moderate claudication

  Baseline to 4 months

• Change in PAD-specific health-related quality of life

  measured using disease specific Peripheral Artery Questionnaire (PAQ) which uses scale scores of 0 to 100, with high numbers indicating better outcomes.

  Baseline to 4 months

• Change in general health-related quality of life

  measured using the EuroQol 5 Dimension Scale (EQ-5D) which is comprised of a descriptive system questionnaire containing 5 questions and a visual analogue scale ranging from 0 to 100 with 0 being worse health state imaginable and 100 being best health state imaginable. The descriptive system questionnaire is scored by assigning a 1-digit number to the participant's answer choice for each of the 5 questions, then combining each into a 5-digit number indicating their health state.

  Baseline to 4 months

• Change in global health-related quality of life

  measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Questionnaire that includes questions from physical, mental, and social health domains and is scored using a T-score metric. A higher score equals more of a concept being measured which can indicate better or worse outcomes depending on the concept being measured.

  Baseline to 4 months

Secondary Outcomes (5)

• Change in pain-free walking distance

  Baseline to 4 months

• Change in maximal walking distance

  Baseline to 12 months

• Change in PAD-specific health-related quality of life

  Baseline to 12 months

• Change in general health-related quality of life

  Baseline to 12 months

• Change in global health-related quality of life

  Baseline to 12 months

Study Arms (4)

Telephone Counseling

ACTIVE COMPARATOR

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

Behavioral: Telephone counseling

Internet-based walking program

EXPERIMENTAL

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

Behavioral: Internet-based walking program

Telephone counseling and Internet-based walking program

EXPERIMENTAL

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.

Behavioral: Telephone counseling; Behavioral: Internet-based walking program

Usual Care

NO INTERVENTION

Subjects will continue with their health care as usual

Interventions

Telephone counseling BEHAVIORAL

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

Telephone Counseling; Telephone counseling and Internet-based walking program

Internet-based walking program BEHAVIORAL

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

Internet-based walking program; Telephone counseling and Internet-based walking program

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (2)

University of Alabama Birmingham

Birmingham, Alabama, 35294, United States

Location

University of Michigan

Ann Arbor, Michigan, 48106, United States

Location

Related Publications (2)

• 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.

  PMID: 29274894 BACKGROUND

• 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.

  PMID: 38655762 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Elizabeth A. Jackson, MD MPH FACC

  University of Alabama at Birmingahm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Four groups are included in this study

Study Record Dates

• First Submitted: December 5, 2013
• First Posted: December 27, 2013
• Study Start: September 1, 2014
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 21, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)