Congenital heart disease: a trial will evaluate home-based physical and cognitive rehabilitation

A programme targeting physical fitness and cognition

The abstract presents neurodevelopmental disorders and physical deconditioning as the most common long-term complications of congenital heart disease. The programme under study therefore combines two components: cardiovascular rehabilitation and executive function training.

The hypothesis is that a combined intervention could improve these young people's physical and mental health. This remains to be tested. The abstract does not establish what contribution each component might make separately.

A comparison with usual care

This European multicentre trial plans to randomly assign participants to two groups. It includes children, adolescents and young adults aged 8 to 25 with complex congenital heart disease who underwent cardiac surgery or a catheter-based cardiac intervention in early childhood.

The intervention group will follow a 12-week home-based programme combining physical activity and neuropsychological training. The control group will receive usual care. All participants will undergo a baseline assessment and follow-up at 12 months. The planned sample size is not stated in the abstract provided.

Quality of life as the primary outcome

The primary outcome will be the change in health-related quality of life, reported by participants using the Pediatric Quality of Life Inventory. The researchers will compare this change between the two groups, from baseline to the 12-month assessment.

Secondary outcomes will include executive function, social cognition and mental health. Physical outcomes will be assessed using measures including maximal oxygen consumption, muscle strength and physical activity levels.

This choice distinguishes a perceived improvement in everyday life from a change on a cognitive test or a measure of physical fitness. The protocol plans to measure these dimensions without assuming that all will improve.

What this publication tells us

QUALINEURO-REHAB proposes a structured way to evaluate combined rehabilitation compared with usual care. The abstract reports registration under the number NCT05670132 and ethical approvals in France, Germany and Belgium.

However, it provides neither efficacy results nor tolerability data. It therefore does not justify undertaking this programme independently or extrapolating its benefits to young people without congenital heart disease.

What we can take away

This trial will test whether home-based physical and cognitive rehabilitation improves quality of life in young people with complex congenital heart disease. For now, this is a hypothesis being evaluated, not demonstrated efficacy.