High-intensity Interval Training Versus Moderate Continuous Training in Heart Transplant Recipients.

October 23, 2023 updated by: Christian Dall, Bispebjerg Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2400
        • Cardiac Rehabilitation, Bispebjerg University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

-stable Heart transplant recipients > 12 month or more after HTx, age > 18 years,< 80. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: high intense interval training
Each AIT session consisted a 10 minute warm-up period followed by 16 minutes of interval training consisting of intervals of 4-3-2 and 1 minutes duration at 85-95% of their peak capacity separated by 2-4 min active rest.
Other: high intense interval training
Each AIT session consisted a 10 minute warm-up period followed by 16 minutes of interval training consisting of intervals of 4-3-2 and 1 minutes duration at 85-95% of their peak capacity separated by 2-4 min active rest.
Active Comparator: continuous moderate training
Continued exercise 45 min.
Other: continuous moderate training
Continued exercise 45 min.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endothelial function (endoPAT)
Time Frame: baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month).
After the release of the cuff the hyperemic response was recorded and the reactive hyperemia index (RHI) was calculated automatic independent of operator. (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
Time Frame: baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month).
SF-36, information on Quality of Life
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
Time Frame: baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month).
Symptoms of anxiety and depression measured by the Hospital Anxiety and Depression Scale (HADS).
baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month).
Bloodsamples/biomarkers.
Time Frame: baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month).
Samples cooled on ice, centrifuged for 10 minutes and the plasma transferred to microtubes and stored at -80°C. Biomarkers analysed at department of biomedicine at University of Copenhagen.
baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month).
augmentation index (AI), endoPAT
Time Frame: baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month).
Augmentation index (AI)derived from pulse wave analyses and is a measure of arterial stiffness, (EndoPAT).
baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Investigators

  • Principal Investigator: Christian H Dall, cand.scient, Bispebjerg Hospital, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

July 25, 2013

First Submitted That Met QC Criteria

July 31, 2013

First Posted (Estimated)

August 2, 2013

Study Record Updates

Last Update Posted (Actual)

October 24, 2023

Last Update Submitted That Met QC Criteria

October 23, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H-3-2010 030

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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