Transplant Trial Watch

Home-based inspiratory muscle training in pediatric patients after kidney transplantation: a randomized clinical trial

Carbonera, R. P., et al.

Pediatric Nephrology 2020; 35(8): 1507-1516.


Aims
The aim of this study was to investigate the effects of inspiratory muscle training (IMT) in pediatric renal transplant patients.

Interventions
Patients were randomly assigned to the training (intervention) group and the placebo (control) group.

Participants
31 paediatric kidney transplant recipients.

Outcomes
The outcomes of interest were the assessment of respiratory muscle strength, pulmonary function and functional capacity, and the evaluation of the biochemical profile of participants following intervention.

Follow-up
6 weeks

CET Conclusions
This double-blinded randomised controlled trial investigated the efficacy of 6-weeks inspiratory muscle training (IMT) in paediatric kidney transplant recipients. Patients up to the age of 18 were randomised using a computerised random number generator to the IMT group or the control group. Participants received a respiratory training device which was wrapped in paper and sealed for blinding purposes. The inspiratory load was set at 40% of the maximal inspiratory pressure (MIP) for the IMT group versus a minimum load as a placebo. The sample size calculation showed that 19 patients per group were needed for 90% power. Thirty-one patients were included in the study. Adherence to the intervention was 81% for the IMT group and 69% for the control group, and none of the patients experienced adverse events. Data showed a significant difference between groups for the predicted percentage of MIP and maximum expiratory pressure after the intervention. However, functional capacity and pulmonary function were not different between groups.

Jadad score
5

Data analysis
Strict intention-to-treat analysis

Allocation concealment
Yes

Trial registration
Registro Brasileiro de Ensaios ClĂ­nicos (ReBEC) - RBR-7pyznv

Funding source
Not reported