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Clinical Trials/NCT01914406
NCT01914406
Completed
Not Applicable

High-intensity Interval Training Versus Moderate Continuous Training in Heart Transplant Recipients With Impaired Chronotropic Response: A Randomized Controlled Crossover Trial.

Bispebjerg Hospital1 site in 1 country20 target enrollmentJanuary 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Transplant Recipients
Sponsor
Bispebjerg Hospital
Enrollment
20
Locations
1
Primary Endpoint
VO2peak
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The aim of this study was to examine the effects of high intensity aerobic interval training (AIT) versus moderate continuous training (CON) in heart transplant recipients.

Detailed Description

Clinically stable heart transplant recipients \> 12 month or more after HTx, age \> 18 years, willing and capable of giving written informed consent for study participation and anticipated to be able to participate in the study for 12 months were included from the Heart Centre, Rigshospitalet, Copenhagen University Hospital. Patients were excluded due to unstable condition or postoperative complications, recent severe rejection episodes (\>H1R \< 3 month), physical disabilities which prevent participation and re-transplantation or multi-organtransplantation.

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
October 2013
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Christian Dall

Associate professor

Bispebjerg Hospital

Eligibility Criteria

Inclusion Criteria

  • stable Heart transplant recipients \> 12 month or more after HTx, age \> 18 years,\<
  • willing and capable of giving written informed consent for study participation.

Exclusion Criteria

  • unstable condition postoperative complications, recent severe rejection episodes (\>H1R \< 3 month), re-transplantation or multi-organtransplantation.

Outcomes

Primary Outcomes

VO2peak

Time Frame: baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month).

baseline test before randomization 1. follow-up after 12 weeks of exercise 2. follow-up after 5 month washout. 3. follow-up after second 12 weeks period of exercise.

Secondary Outcomes

  • Endothelial function (endoPAT)(baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month).)
  • Quality of Life (QoL)SF-36(baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month).)
  • Bloodsamples/biomarkers.(baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month).)
  • HADS-a, HADS-d anxiety and depression(baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month).)
  • augmentation index (AI), endoPAT(baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month).)

Study Sites (1)

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