Physical Activity Daily - An Internet-Based Walking Program for Patients With Peripheral Arterial Disease (PAD)
20. prosince 2021 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
172
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
Alabama
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Birmingham, Alabama, Spojené státy, 35294
- University of Alabama Birmingham
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Michigan
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Ann Arbor, Michigan, Spojené státy, 48106
- University of Michigan
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
40 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: Telephone Counseling
Weekly telephone calls to assess compliance to exercise prescription and discuss various topics related to adoption and adherence to walking programs
|
4 months of weekly contact to update exercise prescription and discuss barriers and challenges to adherence
|
|
Experimentální: Internet-based walking program
Weekly automated goals are delivered via email to subject; goals are based on previous week's step count accumulation.
|
Four-month Internet-based walking program consisting of weekly step count goals
|
|
Experimentální: 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.
|
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
|
|
Žádný zásah: Usual Care
Subjects will continue with their health care as usual
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in maximal walking distance
Časové okno: Baseline to 4 months
|
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
Časové okno: Baseline to 4 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 4 months
|
|
Change in general health-related quality of life
Časové okno: 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
Časové okno: 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.
|
Baseline to 4 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in pain-free walking distance
Časové okno: Baseline to 4 months
|
measured using the Gardner-Skinner protocol treadmill test, time to onset of claudication
|
Baseline to 4 months
|
|
Change in maximal walking distance
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Elizabeth A. Jackson, MD MPH FACC, University of Alabama at Birmingahm
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Užitečné odkazy
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. září 2014
Primární dokončení (Aktuální)
1. prosince 2021
Dokončení studie (Aktuální)
1. prosince 2021
Termíny zápisu do studia
První předloženo
5. prosince 2013
První předloženo, které splnilo kritéria kontroly kvality
20. prosince 2013
První zveřejněno (Odhad)
27. prosince 2013
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
21. prosince 2021
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
20. prosince 2021
Naposledy ověřeno
1. prosince 2021
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- NCT02022423
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