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Effect of a home based, low intensity, physical exercise program in older adults dialysis patients: a secondary analysis of the EXCITE trial
Baggetta R, d'Arrigo G, Torino C, el Hafeez SA, Manfredini F, Mallamaci F, Zoccali C, Tripepi G, on behalf of the EXCITE working group
BMC Geriatrics 2018 Oct 20;18(248):Epub
clinical trial
5/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Older adults dialysis patients represent the frailest subgroup of the end stage renal disease (ESRD) population and physical exercise program may mitigate the age-related decline in muscle mass and function. METHODS: Dialysis patients of the EXCITE trial aged > 65 years (n = 115, active arm, n = 53; control arm, n = 62) were submitted in random order to a home based, low intensity physical exercise program. At baseline and 6 months after exercise training 6-min walking distance (6MWD) and 5-time sit-to-stand test (5STS) were performed, and quality of life (QoL) was tested. RESULTS: The training program improved both the 6MWD (6-months 327 +/- 86 m versus baseline 294 +/- 74 m; p < 0.001) and the 5STS time (6- months 19.8 +/- 5.6 s versus baseline: 22.5 +/- 5.1 s; p < 0.001) in the exercise group whereas they did not change in the control group (p = 0.98 and 0.25, respectively). The between-arms differences (6 months-baseline) in the 6MWD (+34.0 m, 95% CI 14.4 to 53.5 m) and in the 5STS time changes (-1.9 s, 95% CI -3.6 to -0.3 s) were both statistically significant (p = 0.001 and p = 0.024, respectively). The cognitive function dimension of QoL significantly reduced in the control arm (p = 0.04) while it remained unchanged in the active arm (p = 0.78) (between groups difference p = 0.05). No patient died during the trial and the training program was well tolerated. CONCLUSIONS: This secondary analysis of the EXCITE trial shows that a home-based, exercise program improves physical performance and is well tolerated in elderly ESRD patients. TRIAL REGISTRATION: The trial was registered in ClinicalTrials.gov (ClinicalTrials.gov identifier NCT01255969) on December 8, 2010.

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