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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01091194
Other study ID # 10920
Secondary ID
Status Completed
Phase Phase 2
First received March 18, 2010
Last updated February 18, 2013
Start date October 2009
Est. completion date December 2011

Study information

Verified date February 2013
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Interventional

Clinical Trial Summary

This is a randomized controlled trial which will include approximately 50 heart transplant recipients 1-8 years after heart transplantation. The intervention and follow up period is 1 year. The primary purpose is to investigate if systematic, high intensity, interval-based aerobic exercise training results in a greater improvement of exercise capacity (measured by VO2peak) than previously shown in heart transplant recipients.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date December 2011
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Norwegian heart transplanted patients > 18 years of age

- 1-8 years after heart transplantation

- Optimal medical treatment

- Stable condition

- Written informed consent

- Must have access to a physical therapist or personal trainer in their hometown

- Motivation for exercise

Exclusion Criteria:

- Unstable condition

- In need of revascularization or other invention

- Infections, open wounds or skin diseases

- Physical disabilities which prevent participation

- Other diseases, illnesses or conditions which contradict exercise

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Interval-based aerobic exercise
High intensity interval-based aerobic exercise training. Duration: 1 year. Three 8-weeks supervised periods of physical training 3 times per week. Individual training 2 times per week between these periods.

Locations

Country Name City State
Norway Department of Cardiology, Oslo University Hospital, Rikshospitalet Oslo

Sponsors (2)

Lead Sponsor Collaborator
Oslo University Hospital Helse Sor-Ost

Country where clinical trial is conducted

Norway, 

References & Publications (3)

Nytrøen K, Rustad LA, Aukrust P, Ueland T, Hallén J, Holm I, Rolid K, Lekva T, Fiane AE, Amlie JP, Aakhus S, Gullestad L. High-intensity interval training improves peak oxygen uptake and muscular exercise capacity in heart transplant recipients. Am J Tran — View Citation

Nytrøen K, Rustad LA, Gude E, Hallén J, Fiane AE, Rolid K, Holm I, Aakhus S, Gullestad L. Muscular exercise capacity and body fat predict VO(2peak) in heart transplant recipients. Eur J Prev Cardiol. 2014 Jan;21(1):21-9. doi: 10.1177/2047487312450540. Epu — View Citation

Rustad LA, Nytrøen K, Amundsen BH, Gullestad L, Aakhus S. One year of high-intensity interval training improves exercise capacity, but not left ventricular function in stable heart transplant recipients: a randomised controlled trial. Eur J Prev Cardiol. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Peak oxygen uptake (VO2peak) Before and after the intervention period of 1 year No
Secondary Isokinetic muscle strength of quadriceps and hamstrings Before and after the intervention period of 1 year No
Secondary Quality of life measured by questionnaires Before and after the intervention period of 1 year No
Secondary Myocardial function measured by echocardiography Before and after the intervention period of 1 year No
Secondary Progression on coronary atherosclerosis measured by intra vascular ultrasound (IVUS) Before and after the intervention period of 1 year No
Secondary Vascular tone and compliance measured by tonometry Before and after the intervention period of 1 year No
Secondary Regular blood screening, lipid profile, inflammatory status, nerve growth factor, biochemical markers for endothelial function, prothrombotic factor, factors connected to vascularization: NT-proBNP and gene expression analysis. Before and after the intervention period of 1 year No
Secondary Analysis of isolated muscle cells from myocardial biopsy Before and after the intervention period of 1 year No
Secondary Reinnervation as judged by autonomic nervous control (Heart Rate Variability) Before and after the intervention period of 1 year No
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