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临床试验/NCT07132554
NCT07132554已完成不适用

Mixing 1:1 HIIT and MICT in Early to Very Early Phase Heart Transplant (HTx) Recipients : a Retrospective Study From a 510 Patients/12 Years Prospectively-collected Database

Hôpital Léon Bérard0 个研究点目标入组 510 人开始时间: 2012年12月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
510
主要终点
VO2peak

研究概览

简要总结

Background: Exercise-based cardiac rehabilitation is recommended early to very early for heart transplant recipients (HTRs), but data on its feasibility and efficacy at this stage are lacking. Primarily, this study reports the results of an intensive program combining moderate-intensity continuous-training (MICT) and high-intensity interval-training (HIIT) in early HTRs. Secondarily, it explores the determinants of VO2peak in this population.

Methods: A single-center retrospective study of a prospectively-collected database including patients who were consecutively referred to a cardiac rehabilitation unit immediately after discharge from acute post-transplant care, between December 2012 and December 2024. Patients participated in a tailored program combining MICT and HIIT as soon as they could cycle, and performed a first cardiopulmonary exercise test (CPET1) when possible. The initial prescription included 32 planned 30-minute (±5) aerobic sessions for 4 weeks, on a standard or semi-recumbent cycle-ergometer, twice a day (4 days a week) including one session of MICT (PVT and Borg-RPE 12-14) and one session of HIIT (6-8 x 1':3'/ PAT and Borg-RPE ≥ 15), plus additional sessions (respiratory and strengthening physiotherapy, gymnastics or walking, occupational therapy). The primary outcome was improvement in exercise capacity, measured by maximal oxygen consumption (VO2peak) between CPET1 and discharge (CPET2). Secondary outcomes included feasibility criterions (exercise-related adverse events-AE, and completion rates), then clinical, biological and echocardiographic parameters influencing exercise capacity.

详细描述

INTRODUCTION The incidence and prevalence of heart failure (HF) are increasing globally. While its prevalence is estimated at 2% in developed countries, a similar upward trend has been observed in developing countries since the 2000s. This growing burden has led to a parallel rise in cases of advanced HF, a trend primarily driven by an aging population and improved patient survival rates. For patients with advanced HF and no contraindications, heart transplantation (HTx) remains the gold-standard treatment.

Concurrently, exercise capacity is a critical health indicator. In the general population, it is recognized as the strongest predictor of good health and survival, regardless of underlying pathologies. This importance is mirrored in heart transplant recipients (HTR), where enhanced exercise capacity is associated with improved functional status, better quality of life and lower re-hospitalization rates. Furthermore, emerging evidence suggests an inverse relationship with post-transplant mortality. For instance, a +14% increase in maximal oxygen consumption (VO2peak) has been estimated to yield a 32% reduction in mortality.

Exercise-based cardiac rehabilitation programs are the primary intervention for improving exercise capacity after HTx. Their effectiveness in increasing VO2peak was confirmed by a meta-analysis of nine randomized controlled trials (284 patients), the majority of which (n=8) utilized Moderate-Intensity Continuous Training (MICT), yielding a significant mean difference of +2.49 ml/kg/min (95% CI 1.69 to 3.49). However, these studies have limitations. With one exception from the smallest, the trials were conducted in the stable, chronic phase post-HTx (median 12 months) and exhibited significant heterogeneity in the type, volume, and intensity of aerobic exercise prescribed. Notably, despite being a major determinant of program effectiveness, patient adherence was not reported in any of these studies.

A few retrospective studies with small to medium sample sizes, more recently, the largest randomized controlled trial (n=81) to date have explored the effects of early cardiac rehabilitation. While these programs started between 2 and 3 months after HTx, few data exist on very early (≈1 month) standardized rehabilitation programs. In addition, if the ability of MICT to improve cardiorespiratory fitness (CRF) in HTx has been demonstrated, Nytroen et al. demonstrated the efficacy and safety of high-intensity interval training (HIIT) over MICT (SMD +1.8 mL/kg/min), in a long-term (9 months), high-volume (58 sessions x 25 minutes), high-intensity, good adherence, out-patient program.

Yet, recommendations still suggest starting at low intensity (≤50% VO2peak or -10% below the VO2ventilatory threshold), from the 2nd or 3rd post-operative week for the first few weeks, then increasing to MICT and then HIIT depending on tolerance, whereas HIIT should be introduced " only in the further course of clinically stable patient ". However, it may be that initial adherence to and enjoyment of exercise is a cornerstone of long-term physical activity maintenance Rodrigues, especially in the context of HF Klompstra. As described in other population, early in-center peer emulation and addressing the monotony of exercise programs seem important for improving initial management and long-term adherence.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • De Novo Heart Transplant Recipients (HTR)

排除标准

  • 未提供

结局指标

主要结局

VO2peak

时间窗: Baseline (Week 1) Discharge (Week 5)

Main determinant of Exercise capacity, measured during a symptom-limited CardioPulmonary Exercise Test (CPET), performed in routine at our cardiac rehabilitation department

次要结局

  • VO2 vt/at(Baseline (Week 1) Discharge (Week 5))
  • Heart rate(Baseline (Week 1) Discharge (Week 5))
  • Power output(Baseline (Week 1) Discharge (Week 5))
  • O2pulse(Baseline (Week 1) Discharge (Week 5))
  • Echocardiography parameters(Baseline (Week 1) Discharge (Week 5))
  • Biological Parameters/Renal Failure(Baseline (Week 1) Discharge (Week 5))
  • Clinical parameters(Baseline (Week 1))
  • Clinical Parameters(Baseline (Week 1) Discharge (Week 5))

研究者

发起方
Hôpital Léon Bérard
申办方类型
Other
责任方
Principal Investigator
主要研究者

Benjamin BERNUZ, MD

Scientific coordinator

Hôpital Léon Bérard

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