The Effect of Intradialytic Exercise on Dialysis Patient Survival: A Randomized Controlled Trial

Introduction Patients with kidney failure have a high mortality rate. This study aimed to evaluate the effect of intradialytic exercise on survival in patients receiving hemodialysis (HD). Methods In this randomized controlled trial conducted in a HD center in Iran, adult patients receiving chronic HD were randomized to intradialytic exercise (60 minutes) in the second hour of thrice weekly dialysis for 6 months (intervention) or no intradialytic exercise (control). The primary outcome was survival rate at 12 months. Secondary outcomes were serum albumin, hemoglobin, hematocrit, red blood cell count, serum calcium, serum phosphorous, parathyroid hormone, physical function (6-minute walk test) and nutritional status (Geriatric Nutritional Risk Index) during the first 6 months. The trial follow-up period was 12 months. Results The study included 74 participants randomized to intervention (n=37) or control (n=37). Compared with controls, 1-year survival was higher in the intervention group compared with the control group (94% vs 73%, P=0.01). The hazard ratio on univariate analysis in intervention group was 0.17 (95% CI 0.04-0.8; P =0.02) compared to that in control group. During the 6-month intervention period, significant between-group changes were observed in all secondary outcomes between the intervention and control groups. Conclusion Intradialytic exercise performed for at least 60 minutes during thrice weekly dialysis sessions improves survival in adult patients receiving HD. This effect may be mediated by exercise-related improvements in bone mineral metabolism, anemia, physical function or nutritional status. Trial registration [ClinicalTrials.gov][1] Identifier: [NCT04898608][2], Registered on May 21st,2021. Registered trial name: The Effect of Intradialytic Exercise on Dialysis Patients Survival. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial NCT04898608 ### Clinical Protocols ### Funding Statement This study did not receive any funding. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study protocol was approved by Iran National Committee for Ethics in Biomedical Research (approval number IR.IAU.KHUISF.REC.1399.146) I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors. [1]: http://ClinicalTrials.gov [2]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04898608&atom=%2Fmedrxiv%2Fearly%2F2022%2F09%2F15%2F2022.09.10.22279785.atom