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

2020년 4월 17일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (실제)

169

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 다른
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
가짜 비교기: 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
활성 비교기: Audiobooks
Participants in this arm will receive iPods with Audiobooks based on their preferred genres.
iPods with audiobooks
실험적: 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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Average volume of physical activity per week per intervention
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Affect measured by Feeling Scale
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 8 week duration
Number of plays of the audio file per week will be recorded
8 week duration
Future Hospitalizations and/or Mortality
기간: Within 2 years
Participants will be tracked longitudinally throughout health service encounters including physician visits, hospitalizations, and mortality.
Within 2 years

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Dr. David Alter, MD,PhD,FRCPC, Toronto Rehabilitation Institute

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2016년 2월 1일

기본 완료 (실제)

2017년 2월 1일

연구 완료 (실제)

2017년 8월 1일

연구 등록 날짜

최초 제출

2016년 9월 19일

QC 기준을 충족하는 최초 제출

2016년 10월 24일

처음 게시됨 (추정)

2016년 10월 26일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 4월 20일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 4월 17일

마지막으로 확인됨

2020년 4월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 15-9839

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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