High-intensity Interval Training Versus Moderate Continuous Training in Heart Transplant Recipients.

Not Applicable

Completed

• Conditions: Heart Transplant Recipients

• Registration Number: NCT01914406
• Lead Sponsor: Bispebjerg Hospital

Brief Summary

The aim of this study was to examine the effects of high intensity aerobic interval training (AIT) versus moderate continuous training (CON) in heart transplant recipients.

Detailed Description

Clinically stable heart transplant recipients \> 12 month or more after HTx, age \> 18 years, willing and capable of giving written informed consent for study participation and anticipated to be able to participate in the study for 12 months were included from the Heart Centre, Rigshospitalet, Copenhagen University Hospital.

Patients were excluded due to unstable condition or postoperative complications, recent severe rejection episodes (\>H1R \< 3 month), physical disabilities which prevent participation and re-transplantation or multi-organtransplantation.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2013-07-25
• Study First Submitted QC: 2013-07-31
• Study First Posted: 2013-08-02
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

-stable Heart transplant recipients > 12 month or more after HTx, age > 18 years,< 80. willing and capable of giving written informed consent for study participation.

Exclusion Criteria

unstable condition postoperative complications, recent severe rejection episodes (>H1R < 3 month), re-transplantation or multi-organtransplantation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
VO2peak	baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month).	baseline test before randomization; 1. follow-up after 12 weeks of exercise; 2. follow-up after 5 month washout.; 3. follow-up after second 12 weeks period of exercise.

Secondary Outcome Measures

Name	Time	Method
Endothelial function (endoPAT)	baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month).	After the release of the cuff the hyperemic response was recorded and the reactive hyperemia index (RHI) was calculated automatic independent of operator. (endoPAT)
Quality of Life (QoL)SF-36	baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month).	SF-36, information on Quality of Life
Bloodsamples/biomarkers.	baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month).	Samples cooled on ice, centrifuged for 10 minutes and the plasma transferred to microtubes and stored at -80°C. Biomarkers analysed at department of biomedicine at University of Copenhagen.
HADS-a, HADS-d anxiety and depression	baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month).	Symptoms of anxiety and depression measured by the Hospital Anxiety and Depression Scale (HADS).
augmentation index (AI), endoPAT	baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month).	Augmentation index (AI)derived from pulse wave analyses and is a measure of arterial stiffness, (EndoPAT).

Trial Locations

Locations (1)

Cardiac Rehabilitation, Bispebjerg University Hospital; 🇩🇰 Copenhagen, Denmark