High Intensity Training in de Novo Heart Transplant Recipients in Scandinavia (HITTS)
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|ClinicalTrials.gov Identifier: NCT01796379|
Recruitment Status : Active, not recruiting
First Posted : February 21, 2013
Last Update Posted : January 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Heart Transplant Recipients Physical Fitness||Behavioral: High Intensity Interval Training Behavioral: Moderate Training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||High Intensity Training in de Novo Heart Transplant Recipients in Scandinavia|
|Actual Study Start Date :||February 2013|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2035|
|Experimental: High Intensity Interval Training||
Behavioral: High Intensity Interval Training
9 months of high intensity interval based aerobic exercise (3 times/week)
Regular exercise training offered as usual care to all heart transplant recipients.
Behavioral: Moderate Training
Other Name: Regular exercise training offered to all heart transplant recipients (usual care)
- Effect of exercise on peak oxygen uptake [ Time Frame: Baseline to one year ]Change in ml/kg/min
- Effect of exercise on muscle strength [ Time Frame: Baseline to one year ]Change measured in Newtonmeter and Joule
- Effect of exercise on progression of coronary artery vasculopathy (CAV) [ Time Frame: Baseline to one year ]Change measured by intravascular ultrasound; change in maximum intimal thickness, total atheroma volume, percent atheroma volume and virtual histology.
- Effect of exercise on chronotropic responses [ Time Frame: Baseline to one year ]Change in heart rate response, including changes in minimum and maximum heart rate and changes in chronotropic response index.
- Effect of exercise on myocardial function [ Time Frame: Baseline to one year ]Change in echocardiographic parametres such as stroke volume, cardiac index and ejection fraction.
- Effect of exercise on endothelial function [ Time Frame: Baseline to one year ]Change in endothelial function measured by flow mediated dilatation and EndoPat
- Effect of exercise on biomarkers [ Time Frame: Baseline to one year ]Neuroendocrine, inflammatory and immunological biomarkers.
- Effect of exercise on health related quality of life [ Time Frame: Baseline to one year ]Change measured on visual analogue scales and questionnaires
- Effect of exercise on safety and tolerability [ Time Frame: Baseline to 3 years follow-up ]Measured by number of serious adverse effects related to the intervention
- Long-term effects of exercise [ Time Frame: Baseline to 3 years follow-up ]Long-term effects will be measured by all outcomes listed above, including number of serious adverse effects.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01796379
|Copenhagen University Hospital|
|Oslo University Hospital Rikshospitalet|
|Oslo, Norway, 0424|
|Sahlgrenska University Hospital|
|Principal Investigator:||Lars Gullestad, Professor||Oslo Unversity Hospital|