Meditation as a Stress Management Strategy in Cardiac Rehabilitation for Coronary Artery Disease Patients: A Pilot Randomized Controlled Trial (MED-CR-CAD)
2026년 6월 9일 업데이트: DeAsís-Fernández, Francisco, Universidad Rey Juan Carlos
The aim of this pilot randomized controlled trial was to evaluate whether adding a 16-week structured meditation intervention to a long-term (phase III) cardiac rehabilitation program reduces perceived stress and improves anxiety, depression, and health-related quality of life in patients with stable coronary artery disease.
Patients were randomized 1:1 to standard cardiac rehabilitation plus meditation (experimental group) or standard cardiac rehabilitation alone (control group).
The meditation intervention consisted of four weekly 90-minute group sessions followed by 12 weeks of daily individual practice supported by weekly follow-up calls.
Outcomes were assessed at baseline and after 16 weeks.
연구 개요
상태
완전한
상세 설명
Despite advances in cardiac care, psychological stress, anxiety, and depression remain common in patients with coronary artery disease (CAD) and contribute to worse cardiovascular outcomes. Exercise-based cardiac rehabilitation (CR) programs are effective in reducing physical risk factors but often do not adequately address the psychological burden of CAD. Mind-body interventions such as meditation have been suggested as cost-effective adjuncts to CR, but evidence in long-term phase III CR programs remains limited.
This pilot randomized controlled trial was designed to evaluate the additive effect of a structured meditation intervention combining Karuna (compassion) and Metta (loving-kindness) practices, integrated into a long-term CR program. The intervention included four weekly 90-minute group sessions led by a physiotherapist trained in meditation techniques, followed by 12 weeks of daily individual practice (20 minutes/day) supported by recorded video material and weekly follow-up telephone calls. Outcomes were measured at baseline (M0) and after 16 weeks (M1), using validated psychometric instruments administered by telephone interview by a blinded health professional.
연구 유형
중재적
등록 (실제)
40
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Lisbon, 포르투갈
- Cardiovascular Rehabilitation Centre of the University of Lisbon (CRECUL)
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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
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Age ≥ 18 years (male or female).
- Clinically stable coronary artery disease, documented by previous myocardial infarction, coronary artery bypass grafting, percutaneous coronary intervention, or angina pectoris.
- Active participation in the long-term cardiac rehabilitation program for at least 3 months.
- Access to a smartphone, tablet, or computer for telephone follow-up and meditation video materials.
- Written informed consent.
Exclusion Criteria:
- Cognitive impairment that prevents informed consent or questionnaire completion.
- Symptomatic heart failure.
- Cardiac implantable defibrillators or resynchronization devices.
- Lack of access to the technology required for the intervention.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Standard CR + Meditation
Participants received the standard exercise-based cardiac rehabilitation program plus a 16-week structured meditation intervention.
The meditation component included four weekly 90-minute group sessions during the first month (led by a physiotherapist trained in meditation), followed by 12 weeks of daily individual practice (20 minutes/day) supported by a recorded video and weekly follow-up telephone calls.
Each group session included a thought-sharing moment (30 min), a conscious breathing protocol - diaphragmatic 1:2 and heart-focused breathing (30 min), and a guided Karuna (compassion) and Metta (loving-kindness) meditation (30 min).
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A 16-week structured meditation program added to standard cardiac rehabilitation.
During the first month, participants attended four weekly 90-minute group sessions led by a physiotherapist trained in meditation techniques.
Each session included: (1) a 30-minute thought-sharing and Q&A moment; (2) a 30-minute conscious breathing protocol combining diaphragmatic abdominal breathing in a 1:2 inhale-to-exhale ratio and heart-focused breathing; and (3) a 30-minute guided meditation combining Karuna (compassion) and Metta (loving-kindness) practices.
During the subsequent 12 weeks, participants practised individually for 20 minutes per day, supported by a recorded video by the same instructor and weekly follow-up telephone calls to maintain engagement and address questions.
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활성 비교기: Standard CR
Participants received the standard exercise-based cardiac rehabilitation program without the meditation component.
The standard CR program consisted of supervised group exercise sessions three times per week (60 min per session), with combined aerobic and resistance training prescribed according to European Society of Cardiology guidelines.
After completing the 16-week assessment, control-group participants were offered the same breathing and meditation protocol.
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Standard long-term (phase III) exercise-based cardiac rehabilitation program delivered three times per week (60 minutes per session) on non-consecutive days, supervised by exercise physiologists.
Each session included a 10-minute warm-up and cool-down.
Moderate continuous aerobic training was prescribed at 40-75% of heart rate reserve for 20-25 minutes per session using cycle ergometers or treadmills.
Resistance training was performed after the aerobic component (1-2 sets of 8-12 repetitions at approximately 60-80% of one-repetition maximum, with 2-3 minutes rest between sets), according to European Society of Cardiology guidelines.
Heart rate was monitored with a chest band.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Perceived Stress (PSS-10)
기간: baseline and 16 weeks
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The Perceived Stress Scale is a 10-item self-report questionnaire (score range 0-40) assessing the extent to which life events over the previous month are perceived as unpredictable, uncontrollable, and overloading.
Higher scores indicate greater perceived stress.
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baseline and 16 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Anxiety (Beck Anxiety Inventory, BAI)
기간: baseline and 16 weeks
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21-item self-report measure of anxiety symptom severity, score range 0-63.
Severity categories: minimal (0-7), mild (8-15), moderate (16-25), severe (26-63).
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baseline and 16 weeks
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Depression (Beck Depression Inventory-II, BDI-II)
기간: baseline and 16 weeks
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21-item self-report measure of depressive symptom severity, score range 0-63.
Severity categories: minimal (0-13), mild (14-19), moderate (20-28), severe (29-63)
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baseline and 16 weeks
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Health-Related Quality of Life (HeartQoL)
기간: baseline and 16 weeks
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14-item disease-specific HRQoL questionnaire for ischaemic heart disease, providing Physical (10 items), Emotional (4 items), and Global scores.
Higher scores indicate better HRQoL.
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baseline and 16 weeks
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Physical Activity Level (IPAQ-SF)
기간: baseline and 16 weeks
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International Physical Activity Questionnaire - Short Form.
9-item self-report measure categorizing participants into low, moderate, or high physical activity levels based on the past 7 days.
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baseline and 16 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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 (실제)
2021년 1월 1일
기본 완료 (실제)
2023년 6월 1일
연구 완료 (실제)
2023년 6월 1일
연구 등록 날짜
최초 제출
2026년 6월 9일
QC 기준을 충족하는 최초 제출
2026년 6월 9일
처음 게시됨 (실제)
2026년 6월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 9일
마지막으로 확인됨
2026년 6월 1일
추가 정보
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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