Effect of Exercise After Heart Transplantation

Phase 2

Completed

• Conditions: Heart Transplantation
• Interventions: Other: Interval-based aerobic exercise

• Registration Number: NCT01091194
• Lead Sponsor: Oslo University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-03-18
• Study First Submitted QC: 2010-03-22
• Study First Posted: 2010-03-23
• Primary Completion: 2011-10
• Study Completion: 2011-12
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-18
• Last Update Posted: 2013-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	Interval-based aerobic exercise	Interval-based aerobic exercise

Primary Outcome Measures

Name	Time	Method
Peak oxygen uptake (VO2peak)	Before and after the intervention period of 1 year

Secondary Outcome Measures

Name	Time	Method
Isokinetic muscle strength of quadriceps and hamstrings	Before and after the intervention period of 1 year
Quality of life measured by questionnaires	Before and after the intervention period of 1 year
Myocardial function measured by echocardiography	Before and after the intervention period of 1 year
Reinnervation as judged by autonomic nervous control (Heart Rate Variability)	Before and after the intervention period of 1 year
Progression on coronary atherosclerosis measured by intra vascular ultrasound (IVUS)	Before and after the intervention period of 1 year
Vascular tone and compliance measured by tonometry	Before and after the intervention period of 1 year
Analysis of isolated muscle cells from myocardial biopsy	Before and after the intervention period of 1 year
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

Trial Locations

Locations (1)

Department of Cardiology, Oslo University Hospital, Rikshospitalet; 🇳🇴 Oslo, Norway