Transplant Trial Watch

Personalized physical rehabilitation program and employment in kidney transplant recipients: A randomized trial.

Kastelz, A., et al.

Transplant International 2021 [record in progress].


Aims
This study aimed to examine whether a personalised physical rehabilitation program has an effect on the employment status of renal transplant patients.

Interventions
Participants were randomised into two groups: the intervention group, in which the patients participated in a personalised exercise rehabilitation program in addition to standard care, or the control group where the patients received standard care alone.

Participants
135 kidney transplant patients.

Outcomes
The outcomes of interest were employment status, kidney rejection, perceived physical and mental health, and functional capacity.

Follow-up
12 months

CET Conclusions
This is a well-written report of a good quality study. Following at least 2 months after renal transplantation, patients were randomized to standard care or to receive one-to-one resistance training for 60 minutes twice per week. The intervention lasted 12 months and the primary outcome was employment rate, with a sample size based on a pilot study. The statistical analysis was actually per protocol, as a significant number did not complete 12 months in the intervention arm (28/80 assessed at baseline dropped out). The study had been powered for this and also was randomised in a 2:1 ratio assuming that more patients would drop out from the intervention arm than the standard care arm. Computerised randomisation was used. For those unemployed at baseline a significantly higher proportion found work in the intervention group than in the standard care group (52% versus 13%). For those in employment at the start of the study, rates stayed at 100% in both arms. Both groups showed an improvement in Global Physical Health as well as Global Mental Health, but there were larger benefits in the treatment arm. An intention to treat analysis would have given a better understanding of the interventions effect. The per protocol analysis allows for patients who were struggling with employment, physical or mental health to possibly withdraw from the treatment arm. However, the documented reasons for drop outs in the intervention arm indicate that the main reason for doing so was finding a job, and this was the whole point of the study. The control arm was also small, so may give an inaccurate idea of employment numbers compared to the wider transplant population.

Jadad score
3

Data analysis
Per protocol analysis

Allocation concealment
Yes

Trial registration
ClinicalTrials.gov - NCT02409901

Funding source
No funding received