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

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: Heart Transplant Recipients
• Intervention / Treatment: Other: high intense interval training; Other: continuous moderate training

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	baseline test before randomization; follow-up after 12 weeks of exercise; follow-up after 5 month washout.; 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)	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	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	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.	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	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

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

Study record dates

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: Quality of life; endothelial function; Heart transplant recipients; Exercise capacity
• Other Study ID Numbers: H-3-2010 030