RT Journal Article
T1 A Personalized Patient-Centered Intervention to Empower through Physical Activity the Patient in the Dialysis Center: Study Protocol for a Pragmatic Nonrandomized Clinical Trial
A1 Manfredini, Fabio
A1 Lamberti, Nicola
A1 Battaglia, Yuri
A1 Straudi, Sofia
A1 Murri, Martino Belvederi
A1 Donadi, Maria
A1 Piva, Giovanni
A1 Fabbian, Fabio
A1 Lopez-Soto, Pablo Jesus
A1 Grassi, Luigi
A1 Manfredini, Roberto
A1 Basaglia, Nino
A1 Storari, Alda
K1 exercise
K1 chronic kidney disease
K1 exercise testing
K1 rehabilitation
K1 risk factors
K1 depression
K1 Chronic kidney-disease
K1 Stage renal-disease
K1 Exercise
K1 Barriers
K1 Outcomes
K1 Program
AB Sedentariness of patients affected by end-stage kidney disease (ESKD) expose them to high risk of unfavorable clinical outcomes. Exercise training is effective in improving physical function, quality of life (QoL) and long-term outcomes. However, the existing barriers related to patients, programs and dialysis staff limit patient participation and call for new strategies. This pragmatic nonrandomized trial will test the impact on ESKD population of an intervention proposed by an exercise facilitator regularly present in a dialysis center. The patient will be free to choose among three-month walking and/or resistance low-intensity training programs: (a) guided physical activity increase; (b) home-based exercise; (c) in-hospital (pre/post dialysis) supervised exercise; (d) performance assessment only. The first phase will define feasibility and the characteristics and preference of responders. The second phase will evaluate safety and patients' adherence. Outcome measures will be collected at baseline, after three-month and at six-month follow-up. They will include: aerobic capacity, QoL, gait speed, strength, depression and long-term clinical outcomes (hospitalization and mortality). The trial was approved by the Area-Vasta Emilia-Romagna Centro Ethics Committee with approval number 48/2019. Written informed consent will be obtained from all participants. The results of the study will be presented in international congresses, published in peer-reviewed journals and communicated to the patient community. Registration details: Clinicaltrials.gov NCT04282616 [Registered:24/02/2020].
PB Mdpi
YR 2020
FD 2020-12-01
LK https://hdl.handle.net/10668/25636
UL https://hdl.handle.net/10668/25636
LA en
DS RISalud
RD Apr 17, 2025