Physical Activity Daily - An Internet-Based Walking Program for Patients With Peripheral Arterial Disease (PAD)
2021년 12월 20일 업데이트: Elizabeth Anne Jackson, University of Alabama at Birmingham
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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
172
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35294
- University of Alabama Birmingham
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Michigan
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Ann Arbor, Michigan, 미국, 48106
- University of Michigan
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
40년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Telephone Counseling
Weekly telephone calls to assess compliance to exercise prescription and discuss various topics related to adoption and adherence to walking programs
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4 months of weekly contact to update exercise prescription and discuss barriers and challenges to adherence
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실험적: Internet-based walking program
Weekly automated goals are delivered via email to subject; goals are based on previous week's step count accumulation.
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Four-month Internet-based walking program consisting of weekly step count goals
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실험적: 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.
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4 months of weekly contact to update exercise prescription and discuss barriers and challenges to adherence
Four-month Internet-based walking program consisting of weekly step count goals
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간섭 없음: Usual Care
Subjects will continue with their health care as usual
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in maximal walking distance
기간: Baseline to 4 months
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measured using the Gardner-Skinner protocol treadmill test, noting time to moderate claudication
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Baseline to 4 months
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Change in PAD-specific health-related quality of life
기간: Baseline to 4 months
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measured using disease specific Peripheral Artery Questionnaire (PAQ) which uses scale scores of 0 to 100, with high numbers indicating better outcomes.
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Baseline to 4 months
|
|
Change in general health-related quality of life
기간: Baseline to 4 months
|
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
기간: Baseline to 4 months
|
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.
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Baseline to 4 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in pain-free walking distance
기간: Baseline to 4 months
|
measured using the Gardner-Skinner protocol treadmill test, time to onset of claudication
|
Baseline to 4 months
|
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Change in maximal walking distance
기간: Baseline to 12 months
|
measured using the Gardner-Skinner protocol treadmill test, noting time to moderate claudication
|
Baseline to 12 months
|
|
Change in PAD-specific health-related quality of life
기간: Baseline to 12 months
|
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
|
|
Change in general health-related quality of life
기간: Baseline to 12 months
|
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
|
|
Change in global health-related quality of life
기간: Baseline to 12 months
|
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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Elizabeth A. Jackson, MD MPH FACC, University of Alabama at Birmingahm
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2014년 9월 1일
기본 완료 (실제)
2021년 12월 1일
연구 완료 (실제)
2021년 12월 1일
연구 등록 날짜
최초 제출
2013년 12월 5일
QC 기준을 충족하는 최초 제출
2013년 12월 20일
처음 게시됨 (추정)
2013년 12월 27일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 12월 21일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 12월 20일
마지막으로 확인됨
2021년 12월 1일
추가 정보
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