Exercise Training in Adults With Corrected Tetralogy of Fallot

March 5, 2017 updated by: Borut Jug, University Medical Centre Ljubljana

Influence of Different Types of Exercise Training on Selected Cardiovascular Parameters in Adult Individuals With Corrected Tetralogy of Fallot

In this controlled trial, patients with tetralogy of Fallot will be randomized to either interval training, continuous training, or usual care groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients after surgical correction of tetralogy of Fallot (cTF) have impaired exercise tolerance as compared to healthy age-matched individuals. In this controlled trial, patients with cTF will be randomized to either interval training, continuous training, or usual care.

The aim of the study is to compare the effect of interval vs. continuous exercise training on:

i) exercise capacity ii) vascular function iii) arrhythmogenic potential iv) parameters of inflammation, hemostasis and heart failure severity v) health-related quality of life adults with cTF

Study Type

Interventional

Enrollment (Actual)

27

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

  • Slovenia
      • Ljubljana, Slovenia
        • University Medical Centre Ljubljana

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • congenital tetralogy of Fallot surgically corrected in childhood

Exclusion Criteria:

  • contraindications for exercise training,
  • uncontrolled dysrhythmias,
  • uncontrolled heart failure (New York Heart Association (NYHA) stage IV),
  • unstable coronary or other arterial disease,
  • intellectual development disorder,
  • pregnancy.

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Interval training group
Patients to be randomized to the 'interval training group' will have exercise training sessions 3 times per week for a period of 12 weeks. During training, they will undergo interval exercise series composed of high-intensity intervals (80-90% of peak heart rate) and low-intensity intervals (50-70% of peak heart rate).
Other: Exercise training
Patients to be randomized to the 'interval training group' or 'continuous training group' will undergo exercise training sessions 3 times per week for a period of 12 weeks.
Active Comparator: Continuous training group
Patients to be randomized to the 'continuous training group' will have exercise training sessions 3 times per week for a period of 12 weeks. They will undergo moderate continuous exercise training at 70-75% of peak heart rate.
Other: Exercise training
Patients to be randomized to the 'interval training group' or 'continuous training group' will undergo exercise training sessions 3 times per week for a period of 12 weeks.
No Intervention: Usual care group
Patients to be randomized to the 'usual care group' will undergo standard care for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of maximal oxygen uptake during exercise, measured in ml/kg/min
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of the arterial stiffness coefficient
Time Frame: 3 months
3 months
Change of the value of blood fibrinogen, measured in g/l
Time Frame: 3 months
3 months
Change of the value of blood D-dimer, measured in microg/l
Time Frame: 3 months
3 months
Change of the value of blood N terminal-proBNP, measured in ng/l
Time Frame: 3 months
3 months
Change of from-the-questionnaire-obtained quality of life, measured in points
Time Frame: 3 months
3 months
Change of the ECG waves
Time Frame: 3 months
Estimated with digital high-resolution ECG
3 months
Change of the heart rate variability
Time Frame: 3 months
Estimated with digital high-resolution ECG
3 months
Change of flow-mediated dilatation of the brachial artery, measured in %
Time Frame: 3 months
Flow-mediated dilation (FMD) and arterial stiffness
3 months
Change in the result of the 6-minute walking test, measured in metres
Time Frame: 3 months
3 months

Other Outcome Measures

Outcome Measure
Time Frame
Change of the heart rate recovery
Time Frame: 3 months
3 months

Collaborators and Investigators

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

Sponsor

University Medical Centre Ljubljana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2015

Primary Completion (Actual)

March 5, 2017

Study Completion (Actual)

March 5, 2017

Study Registration Dates

First Submitted

December 20, 2015

First Submitted That Met QC Criteria

December 30, 2015

First Posted (Estimate)

December 31, 2015

Study Record Updates

Last Update Posted (Actual)

March 7, 2017

Last Update Submitted That Met QC Criteria

March 5, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UKCLRehab0012015

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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