Physical Activity Daily - An Internet-Based Walking Program for Patients With Peripheral Arterial Disease (PAD)
20. desember 2021 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
172
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Alabama
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Birmingham, Alabama, Forente stater, 35294
- University of Alabama Birmingham
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Michigan
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Ann Arbor, Michigan, Forente stater, 48106
- University of Michigan
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
40 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: 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
|
|
Eksperimentell: 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
|
|
Eksperimentell: 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
|
|
Ingen inngripen: Usual Care
Subjects will continue with their health care as usual
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in maximal walking distance
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in pain-free walking distance
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Elizabeth A. Jackson, MD MPH FACC, University of Alabama at Birmingahm
Publikasjoner og nyttige lenker
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Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. september 2014
Primær fullføring (Faktiske)
1. desember 2021
Studiet fullført (Faktiske)
1. desember 2021
Datoer for studieregistrering
Først innsendt
5. desember 2013
Først innsendt som oppfylte QC-kriteriene
20. desember 2013
Først lagt ut (Anslag)
27. desember 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
21. desember 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. desember 2021
Sist bekreftet
1. desember 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NCT02022423
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