Peripheral Arterial Disease Clinical Trial
— PADOfficial title:
Physical Activity Daily - An Internet-Based Walking Program for Patients With Peripheral Arterial Disease
Verified date | December 2021 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 172 |
Est. completion date | December 2021 |
Est. primary completion date | December 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
United States | University of Alabama Birmingham | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in maximal walking distance | measured using the Gardner-Skinner protocol treadmill test, noting time to moderate claudication | Baseline to 4 months | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Change in pain-free walking distance | measured using the Gardner-Skinner protocol treadmill test, time to onset of claudication | Baseline to 4 months | |
Secondary | Change in maximal walking distance | measured using the Gardner-Skinner protocol treadmill test, noting time to moderate claudication | Baseline to 12 months | |
Secondary | 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 12 months | |
Secondary | 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. | Baseline to 12 months | |
Secondary | 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 12 months |
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