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The Music Activity INTervention for Adherence Improvement Through Neurological Entrainment - II (MAINTAIN-II)

17. dubna 2020 aktualizováno: Dr. David Alter, Toronto Rehabilitation Institute
This study (MAINTAIN -II) aims to examine the effect of audio playlists [with or without Rhythmic Auditory Stimulation (RAS)] on the weekly volume of physical activity. Participants will be randomized into 3 Interventions: Control (standard, usual care), Audiobook, or Tempo-pace Synchronized Playlists (TSP). The investigators also aim to explore the effects of these interventions on mood, perceived exertion and dissociative attention among patients participating in cardiac rehabilitation.

Přehled studie

Detailní popis

Physical activity is associated with a 35% decrease in cardiovascular mortality - a direct result of exercise on the vasculature and an indirect result of exercise lowering CVD risk factors such as lipids and blood pressure. With physical inactivity being one of the major independent risk factors for CVD, structured exercise cardiac rehabilitation programs have been implemented to encourage adherence to physical activity among patients with cardiac related issues. Clinical trial evidence has demonstrated irrefutable mortality and morbidity benefits associated with cardiac rehabilitation especially among patients with established CVD. The mechanisms for improved outcomes are likely multifactorial, including improved preventative self-management, physical activity volume, and cardiopulmonary fitness. Unfortunately the real-world outcome benefits associated with cardiac rehabilitation are undermined by behavioural attrition, with programmatic drop out and suboptimal physical activity adherence patterns that mirror the broader healthy population who are not enrolled in cardiac rehabilitation.

Unfortunately the real-world outcome benefits associated with cardiac rehabilitation are undermined by attrition rates of up to 50% post rehabilitation. The goal would therefore be to introduce a co-intervention that encourages long-term exercise adherence for maximal health improvements in cardiac rehabilitation populations, which might also have broader applicability to other non-cardiac rehab populations.

The prior study, The Music Activity INTervention for Adherence Improvement through Neurological entrainment (MAINTAIN -1), examined the use of Tempo Synchronized Playlists (TSP) on improving exercise adherence within the cardiac rehabilitation program. Weekly volumes of physical activity were compared between groups assigned to 3 interventions: control group receiving Usual Care, TSP, and Tempo-pace Synchronized Playlists with Rhythmic Auditory Stimulation (RAS). Rhythmic Auditory Stimulation is a neurological rehabilitation technique used to accentuate tempo-pace synchrony. The group assigned to the TSP intervention demonstrated a significantly higher volume in weekly exercise than the usual care control group. Furthermore, the group randomized to TSP with RAS partook in twice the amount of weekly physical activity than the TSP group without RAS. Our prior study had several limitations including small sample size and an inability to examine the mechanisms by which RAS tempo-based audio-playlist synchronization mediated increases in physical activity.

The objective of this current study is to build on our previous research by examining the reproducibility of efficacy and exploring the mechanisms such as mood, perceived exertion and dissociative attention, by which the preference-based tempo-pace synchronized playlists improve exercise adherence among patients participating in cardiac rehabilitation. Participants will be randomized into 3 Interventions: Usual Care, Audiobooks, and TSP, that will be assigned during months 2 and 3 of the program. The Usual Care group will feature a nested design by which half patients will randomized to receive a silent track during month 2, and the other half will receive white noise. This sequence will be reversed during month 3. Within the TSP intervention, 2 nested designs will be tested. The first will test RAS with non-RAS. Half of the patients will be randomized to receive TSP with RAS during month 2 of the study, while the other half will receive TSP without RAS during month 2. The sequence will be reversed in month 3. The second will determine the effect on training by comparing 'active' vs. 'passive'. Within the active group, participants will be trained on how to exercise with the music. The passive group will not be trained.

Cardiac Rehabilitation provides an ideal test-case program by which to examine music co-interventions, as it mirrors the behavioural attrition experienced in other structured or unstructured exercise activities. Additionally, a music tempo-pace synchronization strategy is appropriate in such a setting as it helps to regulate the exercise pace prescribed to each patient by the program.

Typ studie

Intervenční

Zápis (Aktuální)

169

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

    • Ontario
      • Toronto, Ontario, Kanada, M4G 2V6
        • Cardiac Rehabilitation and Prevention Program

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

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • Patients with known cardiovascular disease who are participating in and have been declared medically stable for outpatient cardiac rehabilitation
  • Patients must be at least 18 years of age
  • Patients must have received at least one exercise prescription that includes consistent walking and/or running (no high interval training or stationary machines)

Exclusion Criteria:

  • Participants unable to wear the iPod device or activity monitoring device due to medical or non-medical issues
  • Participants with significant communication impairments
  • Participants currently enrolled in another intervention study

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: Jiný
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Falešný srovnávač: Usual Care
Participants in this intervention will receive the minimal standard of care provided at the Cardiac Rehabilitation and Prevention Program at Toronto Rehabilitation Institute. Participants will receive an iPod with a silent track or white noise.
iPods containing either a silent track or white noise
Aktivní komparátor: Audiobooks
Participants in this arm will receive iPods with Audiobooks based on their preferred genres.
iPods with audiobooks
Experimentální: Tempo-pace Synchronized Playlists
Participants in this arm will receive audio playlists synchronized to their exercise pace. Rhythmic enhancements will be added to the playlists during either month 2 or month 3 of the study.
Playlists with or without RAS

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Average volume of physical activity per week per intervention
Časové okno: 12 weeks
The activity monitor will be worn each week for 12 weeks. Average minutes of physical activity per week will be compared between groups.
12 weeks

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Affect measured by Feeling Scale
Časové okno: Biweekly for the duration of 12 weeks
During participant's biweekly exercise session, scores on the Feeling Scale will be recorded per lap.
Biweekly for the duration of 12 weeks
Arousal measured by Score on Felt Arousal
Časové okno: Biweekly for the duration of 12 weeks
During participants biweekly exercise session, scores on the Felt Arousal Scale will be recorded per lap
Biweekly for the duration of 12 weeks
Perceived Exertion measured by Rate of Perceived Exertion Scale
Časové okno: Biweekly for the duration of 12 weeks
During participants biweekly exercise session, scores on the Rate of Perceived Exertion Scale (RPE) will be recorded per lap.
Biweekly for the duration of 12 weeks
Dissociative Attention measured by the Tammen's Scale
Časové okno: Biweekly for the duration of 12 weeks
During participants biweekly exercise session, scores on the Tammen's scale will be recorded per lap.
Biweekly for the duration of 12 weeks
Focus measured by the Focus Questionnaire
Časové okno: Biweekly for the duration of 12 weeks
During participants' biweekly exercise session, focus on the audio in the headphones will be recorded at the end of the exercise.
Biweekly for the duration of 12 weeks
Pacing of Exercise
Časové okno: Biweekly for the duration of 12 weeks
Number of steps in one minute will be counted during exercise session.
Biweekly for the duration of 12 weeks
Lap time
Časové okno: Biweekly for the duration of 12 weeks
Time taken to complete one lap will be recorded for each biweekly exercise session.
Biweekly for the duration of 12 weeks
Playcounts
Časové okno: 8 week duration
Number of plays of the audio file per week will be recorded
8 week duration
Future Hospitalizations and/or Mortality
Časové okno: Within 2 years
Participants will be tracked longitudinally throughout health service encounters including physician visits, hospitalizations, and mortality.
Within 2 years

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Dr. David Alter, MD,PhD,FRCPC, Toronto Rehabilitation Institute

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

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

1. února 2016

Primární dokončení (Aktuální)

1. února 2017

Dokončení studie (Aktuální)

1. srpna 2017

Termíny zápisu do studia

První předloženo

19. září 2016

První předloženo, které splnilo kritéria kontroly kvality

24. října 2016

První zveřejněno (Odhad)

26. října 2016

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

20. dubna 2020

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

17. dubna 2020

Naposledy ověřeno

1. dubna 2020

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • 15-9839

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Usual Care

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