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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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