A Phase 4 interventional study of Exercise in Patients on Dialysis (Hemodialysis, Peritoneal Dialysis), sponsored by Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-04.
Sponsored by Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy · Phase 4, Interventional, and Treatment
To evaluate if a model of intervention based on a low-grade physical program prescribed in the dialysis centre and performed at home can modify the functional capacity and quality of life, reduce the risk of cardiovascular and all-causes mortality, non-fatal cardiovascular events and vascular access failure in dialysis patients.
Background Dialysis patients show an exceedingly higher risk of death and cardiovascular complications (1). These patients are also characterized by poor physical performance and reduced quality of life. Observational findings in the United States Renal Data System (USRDS) indicated that physical rehabilitation programs after coronary artery bypass are associated with better clinical outcomes in this population (2). However, the hypothesis that physical training in dialysis patients may translate into better physical performance and clinical outcomes has never been tested in large randomized clinical trials. In studies performed so far, physical exercise was proposed during the dialysis session or between two dialysis sessions. These programs imply compliance, organization and cost problems, mainly related with intensification of visit to the dialysis centre. To limit these difficulties, a single easy-to-implement program of physical exercise for dialysis patients, prescribed in the dialysis centre but performed at home, has been recently elaborated and a pilot study has shown that this program improves physical performance in medium term (3).
Purpose This clinical trial tests whether a physical program prescribed in the dialysis centre but performed at home improves the degree of fitness and the quality of life in dialysis patients.
Study population
Inclusion Criteria:
Exclusion Criteria:
Outcomes:
In a previous observational study by our group, the incident rate of fatal and non fatal cardiovascular events was at three years 25% (4). We hypothesised that the physical exercise will produce a 10% reduction in the hazard ratio of fatal cardiovascular events (hazard ratio: 0.70) as compared to that of the control group.
References:
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
-any physical or clinical limitations to deambulation
Patients in this arm will undergo to personalized exercise program.
Other: Exercise
Personalized exercise program
Assessment of Quality of Life (QoL) modification by the KIDNEY DISEASE QUALITY OF LIFE (KDQOL)questionary
6 months is the time frame for the primary analysis but the follow-up will continue until 3 years.
Time frame: 6 months
Assessment of functional capacity by Six-Minute Walking test and Sit-to-Stand-to-sit test
6 months is the time frame for the primary analysis but the follow-up will continue until 3 years.
Time frame: 6 months
Evaluation of mortality (all causes and cardiovascular only), non-fatal cardiovascular events, all-causes hospitalizations and dialysis access survival.
6 months is the time frame for the primary analysis but the follow-up will continue until 3 years.
Time frame: 6 months
All - causes and cardiovascular hospitalizations
Hospitalizations will be characterized by ICD-9 codes. Six months is the time frame for the primary analysis but the follow-up will continue until 3 years.
Time frame: 6 months
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy