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

20 dicembre 2021 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

172

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Alabama
      • Birmingham, Alabama, Stati Uniti, 35294
        • University of Alabama Birmingham
    • Michigan
      • Ann Arbor, Michigan, Stati Uniti, 48106
        • University of Michigan

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

40 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Telephone Counseling
Weekly telephone calls to assess compliance to exercise prescription and discuss various topics related to adoption and adherence to walking programs
Comportamentale: Telephone counseling
4 months of weekly contact to update exercise prescription and discuss barriers and challenges to adherence
Sperimentale: Internet-based walking program
Weekly automated goals are delivered via email to subject; goals are based on previous week's step count accumulation.
Comportamentale: Internet-based walking program
Four-month Internet-based walking program consisting of weekly step count goals
Sperimentale: 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.
Comportamentale: Telephone counseling
4 months of weekly contact to update exercise prescription and discuss barriers and challenges to adherence
Comportamentale: Internet-based walking program
Four-month Internet-based walking program consisting of weekly step count goals
Nessun intervento: Usual Care
Subjects will continue with their health care as usual

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in maximal walking distance
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in pain-free walking distance
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Alabama at Birmingham

Investigatori

  • Investigatore principale: Elizabeth A. Jackson, MD MPH FACC, University of Alabama at Birmingahm

Pubblicazioni e link utili

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Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 settembre 2014

Completamento primario (Effettivo)

1 dicembre 2021

Completamento dello studio (Effettivo)

1 dicembre 2021

Date di iscrizione allo studio

Primo inviato

5 dicembre 2013

Primo inviato che soddisfa i criteri di controllo qualità

20 dicembre 2013

Primo Inserito (Stima)

27 dicembre 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

21 dicembre 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 dicembre 2021

Ultimo verificato

1 dicembre 2021

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NCT02022423

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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