Chronic Renal Failure, Hemodialysis Treatment, Protein-energy Wasting Clinical Trial
Official title:
Effect of Intradialytic Physical ACTIvity in Addition to a NUTritional Support on Protein Energy Wasting and Physical Functioning in Chronic Hemodialysis Patients ("ACTINUT" Study), Multicenter, Randomized, Controlled Open Label Trial Study Multicenter, Prospective, Randomized Study
Sedentary behavior and protein-energy wasting (PEW) are well known risk factors of adverse
outcome and low quality of life in chronic renal failure patients treated by dialysis.
Treatment strategies of PEW by different types of nutritional support (as dietary
counseling, oral nutritional supplements or intradialytic parenteral nutrition) have limited
efficacy. Physical activity has been shown to have numerous positive impacts in pathologic
conditions associated to end stage renal disease.
Concomitant prescription of physical activity and nutritional support might mutually enhance
the anabolic effects of these interventions and improve the rate of remission of PEW.
The aim of this study is to analyze the effect of a programmed, progressive endurance
training performed during the dialysis session on a cycle ergometer under the supervision of
a qualified trainer, on protein energy wasting and physical functioning of chronic
hemodialysis patients.
Aim 1: To determine the percentage of patients in remission from the state of protein- energy wasting. Hypothesis 1: Patients in the exercise group will more frequently reverse the PEW than in the control group Aim 2: To determine the patterns of change in body composition (fat free mass). Hypothesis 2: Patients in the exercise group will maintain or increase their fat free mass and patients in the control group will decrease their fat free mass Aim 3: To determine the effects of exercise on muscle strength. Hypothesis 3: Patients in the exercise group will maintain or increase their quadriceps strength while patients in the control group will decrease their muscle strength Aim 4: To determine the effects of exercise on postural balance. Hypothesis 4: Patients in the exercise group will maintain or increase their body balance while patients in the control group will decrease their body balance Aim 5: To determine the effects of exercise on quality of life as assessed by the SF-36. Hypothesis 5: Patients in exercise group will maintain or increase their quality of life form while patients in the control group will decrease their quality of life ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment