Completed

HITTSHigh Intensity Training in de Novo Heart Transplant Recipients in Scandinavia

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What is being tested

High Intensity Interval Training

+ Moderate Training

Behavioral
Who is being recruted

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorOslo University Hospital
Last updated: December 9, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

Compared to end-stage heart failure, a patient's situation is usually greatly improved after a heart transplant (HTx), but the exercise capacity remains sub-normal, also long-term, ranging from 50 to 70% in most studies. While effective rehabilitation, including regular exercise, is considered an effective tool of improving health related quality of life (HRQoL) and prognosis of cardiac patients in general, the knowledge about and the effect of different rehabilitation programs among HTx recipients is limited. Exercise training is considered one of the most central parts in rehabilitation, but the mode of exercise used in different studies varies considerably. It is documented that high intensity interval training (HIT) has superior effects compared to training with moderate intensity in cardiac and heart failure patients. In contrast, HTx recipients have a denervated heart, and HIT had been considered unphysiological. However, the investigators have recently demonstrated highly beneficial effects on exercise capacity, muscle strength, body composition, reduced progression of cardiac allograft vasculopathy and HRQoL among long-term HTx recipients. In the present study the investigators want to test the hypothesis that systematic aerobic exercise with high intensity improve exercise capacity also in newly transplanted recipients, and secondarily that it gives favourable effects on the heart, peripheral circulation and a better HRQoL.

Principal SponsorOslo University Hospital
Last updated: December 9, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
Age > 18 years, both sexes

Clinically stable HTx recipients approximately 8-12 weeks after HTx

Patient willing and capable of giving written informed consent for study participation and anticipated to be able to participate in the study for 9- 12 months

Received immunosuppressive therapy as per local protocol

4 exclusion criteria prevent from participating
Other diseases or disabilities that contradict/refrain from exercise

Physical disabilities which prevent participation

Recent severe rejection episodes

Unstable condition or postoperative complications

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Regular exercise training offered as usual care to all heart transplant recipients.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Copenhagen University Hospital

Copenhagen, DenmarkOpen Copenhagen University Hospital in Google Maps

Oslo University Hospital Rikshospitalet

Oslo, Norway

Sahlgrenska University Hospital

Gothenburg, Sweden
Completed3 Study Centers