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

Heart Transplant Recipients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01914406
• Other study ID #: H-3-2010 030
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: October 2013

Study information

• Verified date: October 2023
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Transplant Recipients

Intervention

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.
• continuous moderate training
Continued exercise 45 min.

Locations

Country	Name	City	State
Denmark	Cardiac Rehabilitation, Bispebjerg University Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).