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

Primary Purpose

Peripheral Arterial Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telephone counseling
Internet-based walking program
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Peripheral Arterial Disease focused on measuring peripheral arterial disease, walking, eHealth, telehealth

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama Birmingham
  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

No Intervention

Arm Label

Telephone Counseling

Internet-based walking program

Telephone counseling and Internet-based walking program

Usual Care

Arm Description

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

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

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.

Subjects will continue with their health care as usual

Outcomes

Primary Outcome Measures

Change in maximal walking distance
measured using the Gardner-Skinner protocol treadmill test, noting time to moderate claudication
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.
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.
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.

Secondary Outcome Measures

Change in pain-free walking distance
measured using the Gardner-Skinner protocol treadmill test, time to onset of claudication
Change in maximal walking distance
measured using the Gardner-Skinner protocol treadmill test, noting time to moderate claudication
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.
Change in general health-related quality of life
measured using 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.
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.

Full Information

First Posted
December 5, 2013
Last Updated
December 20, 2021
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT02022423
Brief Title
Physical Activity Daily - An Internet-Based Walking Program for Patients With Peripheral Arterial Disease
Acronym
PAD
Official Title
Physical Activity Daily - An Internet-Based Walking Program for Patients With Peripheral Arterial Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
December 2021 (Actual)
Study Completion Date
December 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
peripheral arterial disease, walking, eHealth, telehealth

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Four groups are included in this study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
172 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telephone Counseling
Arm Type
Active Comparator
Arm Description
Weekly telephone calls to assess compliance to exercise prescription and discuss various topics related to adoption and adherence to walking programs
Arm Title
Internet-based walking program
Arm Type
Experimental
Arm Description
Weekly automated goals are delivered via email to subject; goals are based on previous week's step count accumulation.
Arm Title
Telephone counseling and Internet-based walking program
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Subjects will continue with their health care as usual
Intervention Type
Behavioral
Intervention Name(s)
Telephone counseling
Intervention Description
4 months of weekly contact to update exercise prescription and discuss barriers and challenges to adherence
Intervention Type
Behavioral
Intervention Name(s)
Internet-based walking program
Intervention Description
Four-month Internet-based walking program consisting of weekly step count goals
Primary Outcome Measure Information:
Title
Change in maximal walking distance
Description
measured using the Gardner-Skinner protocol treadmill test, noting time to moderate claudication
Time Frame
Baseline to 4 months
Title
Change in PAD-specific health-related quality of life
Description
measured using disease specific Peripheral Artery Questionnaire (PAQ) which uses scale scores of 0 to 100, with high numbers indicating better outcomes.
Time Frame
Baseline to 4 months
Title
Change in general health-related quality of life
Description
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.
Time Frame
Baseline to 4 months
Title
Change in global health-related quality of life
Description
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.
Time Frame
Baseline to 4 months
Secondary Outcome Measure Information:
Title
Change in pain-free walking distance
Description
measured using the Gardner-Skinner protocol treadmill test, time to onset of claudication
Time Frame
Baseline to 4 months
Title
Change in maximal walking distance
Description
measured using the Gardner-Skinner protocol treadmill test, noting time to moderate claudication
Time Frame
Baseline to 12 months
Title
Change in PAD-specific health-related quality of life
Description
measured using disease specific Peripheral Artery Questionnaire (PAQ) which uses scale scores of 0 to 100, with high numbers indicating better outcomes.
Time Frame
Baseline to 12 months
Title
Change in general health-related quality of life
Description
measured using 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.
Time Frame
Baseline to 12 months
Title
Change in global health-related quality of life
Description
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.
Time Frame
Baseline to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth A. Jackson, MD MPH FACC
Organizational Affiliation
University of Alabama at Birmingahm
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29274894
Citation
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.
Results Reference
background
Links:
URL
http://www.activitydaily.org
Description
Study website, can be used to request information

Learn more about this trial

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

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