Effect of Exercise After Heart Transplantation (TEX)

This study has been completed.

Sponsor:

Collaborator:

Helse Sor-Ost

Information provided by (Responsible Party):

Oslo University Hospital

ClinicalTrials.gov Identifier:

NCT01091194

First received: March 18, 2010

Last updated: February 18, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

March 18, 2010

Last Updated Date

February 18, 2013

Start Date ^ICMJE

October 2009

Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Peak oxygen uptake (VO2peak) [ Time Frame: Before and after the intervention period of 1 year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01091194 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Isokinetic muscle strength of quadriceps and hamstrings [ Time Frame: Before and after the intervention period of 1 year ] [ Designated as safety issue: No ]
Quality of life measured by questionnaires [ Time Frame: Before and after the intervention period of 1 year ] [ Designated as safety issue: No ]
Myocardial function measured by echocardiography [ Time Frame: Before and after the intervention period of 1 year ] [ Designated as safety issue: No ]
Progression on coronary atherosclerosis measured by intra vascular ultrasound (IVUS) [ Time Frame: Before and after the intervention period of 1 year ] [ Designated as safety issue: No ]
Vascular tone and compliance measured by tonometry [ Time Frame: Before and after the intervention period of 1 year ] [ Designated as safety issue: No ]
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. [ Time Frame: Before and after the intervention period of 1 year ] [ Designated as safety issue: No ]
Analysis of isolated muscle cells from myocardial biopsy [ Time Frame: Before and after the intervention period of 1 year ] [ Designated as safety issue: No ]
Reinnervation as judged by autonomic nervous control (Heart Rate Variability) [ Time Frame: Before and after the intervention period of 1 year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Isokinetic muscle strength of quadriceps and hamstrings [ Time Frame: Before and after the intervention period of 1 year ] [ Designated as safety issue: No ]
Quality of life measured by questionnaires [ Time Frame: Before and after the intervention period of 1 year ] [ Designated as safety issue: No ]
Myocardial function measured by echocardiography [ Time Frame: Before and after the intervention period of 1 year ] [ Designated as safety issue: No ]
Progression on coronary atherosclerosis measured by IVUS [ Time Frame: Before and after the intervention period of 1 year ] [ Designated as safety issue: No ]
Vascular tone and compliance [ Time Frame: Before and after the intervention period of 1 year ] [ Designated as safety issue: No ]
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. [ Time Frame: Before and after the intervention period of 1 year ] [ Designated as safety issue: No ]
Analysis of isolated muscle cells from myocardial biopsy [ Time Frame: Before and after the intervention period of 1 year ] [ Designated as safety issue: No ]
Reinnervation as judged by autonomic nervous control (Heart Rate Variability) [ Time Frame: Before and after the intervention period of 1 year ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effect of Exercise After Heart Transplantation

Official Title ^ICMJE

Effect of High Intensity Interval-based Aerobic Exercise 1-8 Years After Heart Transplantation. 1 Year Follow Up.

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Heart Transplantation

Intervention ^ICMJE

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.

Other Name: physical activity, fitness

Study Arm (s)

Exercise
Interval-based aerobic exercise

Intervention: Other: Interval-based aerobic exercise
No Intervention: Control
No intervention other than regular follow up hospital visits

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2011

Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Norway

Administrative Information

NCT Number ^ICMJE

NCT01091194

Other Study ID Numbers ^ICMJE

10920

Has Data Monitoring Committee

Responsible Party

Oslo University Hospital

Study Sponsor ^ICMJE

Oslo University Hospital

Collaborators ^ICMJE

Helse Sor-Ost

Investigators ^ICMJE

Study Director:

Lars Gullestad, MD,PhD,Prof.

Oslo University Hospital, Rikshospitalet

Information Provided By

Oslo University Hospital

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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