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

2020年4月17日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

169

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Ontario
      • Toronto、Ontario、カナダ、M4G 2V6
        • Cardiac Rehabilitation and Prevention Program

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:他の
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
偽コンパレータ: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
アクティブコンパレータ:Audiobooks
Participants in this arm will receive iPods with Audiobooks based on their preferred genres.
iPods with audiobooks
実験的: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

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Average volume of physical activity per week per intervention
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Affect measured by Feeling Scale
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠:8 week duration
Number of plays of the audio file per week will be recorded
8 week duration
Future Hospitalizations and/or Mortality
時間枠:Within 2 years
Participants will be tracked longitudinally throughout health service encounters including physician visits, hospitalizations, and mortality.
Within 2 years

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Dr. David Alter, MD,PhD,FRCPC、Toronto Rehabilitation Institute

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2016年2月1日

一次修了 (実際)

2017年2月1日

研究の完了 (実際)

2017年8月1日

試験登録日

最初に提出

2016年9月19日

QC基準を満たした最初の提出物

2016年10月24日

最初の投稿 (見積もり)

2016年10月26日

学習記録の更新

投稿された最後の更新 (実際)

2020年4月20日

QC基準を満たした最後の更新が送信されました

2020年4月17日

最終確認日

2020年4月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 15-9839

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

Usual Careの臨床試験

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