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

17 avril 2020 mis à jour par: 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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

169

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur factice: 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
Comparateur actif: Audiobooks
Participants in this arm will receive iPods with Audiobooks based on their preferred genres.
iPods with audiobooks
Expérimental: 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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Average volume of physical activity per week per intervention
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Affect measured by Feeling Scale
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 8 week duration
Number of plays of the audio file per week will be recorded
8 week duration
Future Hospitalizations and/or Mortality
Délai: Within 2 years
Participants will be tracked longitudinally throughout health service encounters including physician visits, hospitalizations, and mortality.
Within 2 years

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Dr. David Alter, MD,PhD,FRCPC, Toronto Rehabilitation Institute

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 février 2016

Achèvement primaire (Réel)

1 février 2017

Achèvement de l'étude (Réel)

1 août 2017

Dates d'inscription aux études

Première soumission

19 septembre 2016

Première soumission répondant aux critères de contrôle qualité

24 octobre 2016

Première publication (Estimation)

26 octobre 2016

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

20 avril 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 avril 2020

Dernière vérification

1 avril 2020

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • 15-9839

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

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