High Intensity Training in de Novo Heart Transplant Recipients in Scandinavia (HITTS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Oslo University Hospital
Sponsor:
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01796379
First received: February 18, 2013
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Exercise Capacity
Behavioral: High Intensity Interval Training
Behavioral: Moderate Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: High Intensity Training in de Novo Heart Transplant Recipients in Scandinavia

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Peak oxygen uptake [ Time Frame: Change from baseline to one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Muscle strength [ Time Frame: Change from baseline to one year ] [ Designated as safety issue: No ]
  • Progression of coronary artery vasculopathy [ Time Frame: Change from baseline to one year ] [ Designated as safety issue: No ]
    development of coronary artery vasculopathy (CAV) as assessed by intravascular ultrasound (IVUS).

  • Reinnervation [ Time Frame: Change from baseline to one year ] [ Designated as safety issue: No ]
    Reinnervation as assessed by chronotropic response during exercise

  • Myocardial function [ Time Frame: Change from baseline to one year ] [ Designated as safety issue: No ]
    myocardial function as assessed by echocardiography

  • Endothelial function [ Time Frame: Change from baseline to one year ] [ Designated as safety issue: No ]
    endothelial function as assessed by Endopath

  • Biomarkers [ Time Frame: Change from baseline to one year ] [ Designated as safety issue: No ]
    neuroendocrine, inflammatory and immunological biomarkers.

  • Health related quality of life [ Time Frame: Change from baseline to one year ] [ Designated as safety issue: No ]
    health related quality of life (HRQoL) measured by Short Form 36 and Hospital Anxiety and Depression Scale.

  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: February 2013
Estimated Study Completion Date: December 2030
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Intensity Training Behavioral: High Intensity Interval Training
9 months of high intensity interval based aerobic exercise (3 times/week)
Moderate Training
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinically stable HTx recipients approximately 8-12 weeks after HTx.
  • Age > 18 years, both sexes
  • Received immunosuppressive therapy as per local protocol.
  • 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.

Exclusion Criteria:

  • Unstable condition or postoperative complications
  • Recent severe rejection episodes
  • Physical disabilities which prevent participation
  • Other diseases or disabilities that contradict/refrain from exercise.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01796379

Contacts
Contact: Lars Gullestad, Professor lars.gullestad@medisin.uio.no
Contact: Kari Nytrøen, PhD student knytroen@ous-hf.no

Locations
Denmark
Aarhus University Hospital Not yet recruiting
Aarhus, Denmark
Copenhagen University Hospital Not yet recruiting
Copenhagen, Denmark
Norway
Oslo University Hospital Rikshospitalet Recruiting
Oslo, Norway, 0424
Contact: Kari Nytrøen, PhD student       knytroen@ous-hf.no   
Principal Investigator: Lars Gullestad, Professor         
Sweden
Sahlgrenska University Hospital Not yet recruiting
Gothenburg, Sweden
Sponsors and Collaborators
Oslo University Hospital
  More Information

Publications:
Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01796379     History of Changes
Other Study ID Numbers: 9378
Study First Received: February 18, 2013
Last Updated: April 8, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

ClinicalTrials.gov processed this record on October 02, 2014