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

Study Overview
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Brief Summary
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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
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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.

Official Title
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High-intensity Interval Training Versus Moderate Continuous Training in Heart Transplant Recipients With Impaired Chronotropic Response: A Randomized Controlled Crossover Trial.

Conditions
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Heart Transplant Recipients

Intervention / Treatment
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* Other: high intense interval training
* Other: continuous moderate training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: high intense interval training<br>Each AIT session consisted a 10 minute warm-up period followed by 16 minutes of interval training consisting of intervals of 4-3-2 and 1 minutes duration at 85-95% of their peak capacity separated by 2-4 min active rest. | Other: high intense interval training<br>* Each AIT session consisted a 10 minute warm-up period followed by 16 minutes of interval training consisting of intervals of 4-3-2 and 1 minutes duration at 85-95% of their peak capacity separated by 2-4 min active rest.<br>|
| Active Comparator: continuous moderate training<br>Continued exercise 45 min. | Other: continuous moderate training<br>* Continued exercise 45 min.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VO2peak | baseline test before randomization follow-up after 12 weeks of exercise follow-up after 5 month washout. follow-up after second 12 weeks period of exercise. | baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function (endoPAT) | After the release of the cuff the hyperemic response was recorded and the reactive hyperemia index (RHI) was calculated automatic independent of operator. (endoPAT) | baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month). | 
| Quality of Life (QoL)SF-36 | SF-36, information on Quality of Life | baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month). | 
| HADS-a, HADS-d anxiety and depression | Symptoms of anxiety and depression measured by the Hospital Anxiety and Depression Scale (HADS). | baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month). | 
| Bloodsamples/biomarkers. | 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. | baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month). | 
| augmentation index (AI), endoPAT | Augmentation index (AI)derived from pulse wave analyses and is a measure of arterial stiffness, (EndoPAT). | baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart transplant recipients, Exercise capacity, endothelial function, Quality of life