Exercise Training in Adults With Corrected Tetralogy of Fallot

University Medical Centre Ljubljana

Status: Completed

Conditions: Tetralogy of Fallot

Treatments: Other: Exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT02643810

UKCLRehab0012015

Details and patient eligibility

About

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

Full 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

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 3 patient groups

Interval training group

Active Comparator group

Description:

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).

Treatment:

Other: Exercise training

Continuous training group

Active Comparator group

Description:

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.

Treatment:

Other: Exercise training

Usual care group

No Intervention group

Description:

Patients to be randomized to the 'usual care group' will undergo standard care for 12 weeks.