Long Term Effect of High-intensity Training After Heart Transplantation

Study Overview
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Brief Summary
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High-intensity training (HIT) has repeatedly been documented to have superior positive effects compared to moderate exercise in patients with coronary heart disease and heart failure. Since heart transplant recipients (HTx), have a denervated heart with different respond to exercise, HIT has previously not been introduced among these patients. Rikshospitalet carried out a RCT to investigate this (the TEX study 2009-2012), and found that this form of exercise also was highly effective and safe in long term HTx with clinically significant improvement in VO2peak, muscular exercise capasity, general HRQoL, and even slower progression of CAV (coronary allograft vasculopathy). Based on these findings we ask the following questions in this follow-up study: Would the effect on VO2peak, HRQoL,muscle capacity and CAV obtained during the study period continue during long term follow up (5 years)? Is the intervention group more physical active after HIT compared to the control group?

Conditions
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Heart Transplant Recipients

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: stable situation optimal medical treatment written concent Exclusion Criteria: unstable situation, infections (open wounds or skin diseases), physical conditions that prevents participation, or other injuries/ diseases who are contraindicated with training.

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention group<br>Group that followed high- intensity interval training program in TEX study. | |
| Control group<br>Followed up on a regular basis for HTx recipients in Norway. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean VO2peak in the intervention group and control group | We will use the same test protocol as the TEX- study. | 5 years after start of inclusion in RCT (TEX). One measurment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| How many has progression of cardiac allograft vasculopathy in the intervention group and control group. | Progression of vasculopathy will be studied with IVUS technique, and compared with IVUS pictures from TEX. | 5 years after inclusion in RCT (TEX study). | 
| Mean muscle capacity in the intervention group and control group. |  | 5 years after inclusion in RCT, TEX study. | 
| Quality of life | We will use validated questionnaires to estimate quality of life and to evaluate depression. | 5 years after inclusion in TEX- study. | 
| Difference in activity level between groups | To estimate activity the study population will fill out a validated questionnaire about physical activity, and they will wear a physical activity monitor at home for one week. | 5 years after inclusion i RCT, TEX study. |