INTRODUCTION: Physical functioning and diet may be promising targets to improve sleep and reduce fatigue among kidney transplant recipients (KTRs). We investigated whether a lifestyle intervention consisting of exercise or exercise combined with diet improve self-reported sleep and fatigue among KTRs. METHODS: A predefined analysis of the Dutch multicenter randomized controlled Active Care after Transplantation (ACT) study (NCT01047410) was performed. Participants were allocated to control, exercise or exercise plus diet. The exercise group received 3 months supervised exercise with 15 months lifestyle coaching. This was supplemented with 15 months dietary counseling for the exercise plus diet group. Sleep and fatigue were assessed using the Kidney Disease Quality of Life-Short Form (KDQOL-SF) and the checklist of individual strength 20 (CIS20). RESULTS: We included 146 KTRs (36% female, mean age 54 +/- 1 yr); 44 received usual care, 57 exercise intervention, and 45 exercise plus diet intervention. Mixed model analyses showed comparable sleep and fatigue trajectories across groups. At 15 months, no effects of the exercise intervention were observed for sleep (-2.5 arbitrary units (AU), 95% confidence interval (CI) -9.1 to 4.2) and fatigue (-1.4 AU, 95% CI -7.0 to 4.2). Similarly, at 15 months, no effects of the exercise plus diet intervention were observed for sleep (-1.4 AU, 95% CI -8.4 to 5.6) and fatigue (-0.2 AU, 95% CI -6.2 to 5.8). Fatigue improved compared with baseline at all time points (p <= 0.001). Of those with severe fatigue, 96% were able to follow the study protocol. CONCLUSIONS: Although patient-reported fatigue improves in the first year posttransplantation, (severe) fatigue remains highly prevalent and persisting among KTRs. Participation in a lifestyle rehabilitation program is feasible for KTRs with severe fatigue, but it neither improves nor worsens sleep or fatigue.

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