Mixing 1:1 HIIT and MICT in Early to Very Early Phase HTx Recipients : a Retrospective Study From a 510 Patients/12 Years Database

NCT07132554 | Completed

• 1 other identifier: COMET-HT2012-2024
• Study Type: observational
• Target: 510
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Heart Transplant Recipients

Keywords

Exercise-based cardiac rehabilitation; VO2peak; Combine Moderate and Intense Training; Early-to-very-early phase post-HTx; Exercise capacity determinants

Outcome Measures

Primary Outcomes (1)

• VO2peak

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

  Baseline (Week 1) Discharge (Week 5)

Secondary Outcomes (11)

• 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)

Interventions

Combined 1:1 MICT and HIIT aerobic cardiac rehabilitation OTHER

Combining 1:1 MICT and HIIT in short (4 weeks) high-volume (32 sessions) early-to-very-early phase program post heart transplantation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

De novo HTR, after Heart failure from any etiology, at any age, from 3 University Transplantation units in the south-eastern quarter of France, admitted in our rehabilitation center for cardiac rehabilitation

You may qualify if:

• De Novo Heart Transplant Recipients (HTR)

You may not qualify if:

• None

Sponsors & Collaborators

• Hôpital Léon Bérard: lead
• Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL) - France: collaborator
• Centre Hospitalier Toulon: collaborator

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific coordinator

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: August 20, 2025
• Study Start: December 1, 2012
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: August 20, 2025

Record last verified: 2025-08