Effects of a six-month intradialytic physical ACTIvity program and adequate NUTritional support on protein-energy wasting, physical functioning and quality of life in chronic hemodialysis patients: ACTINUT study protocol for a randomised controlled trial.

BACKGROUND: Protein-energy wasting (PEW) is common in hemodialysis patients and is a powerful predictor of morbidity and mortality. Although much progress has been made in recent years in identifying the causes and pathogenesis of PEW in hemodialysis patients, actual management by nutritional interventions is not always able to correct PEW. Some investigators suggest that physical exercise may increase the anabolic effects of nutritional interventions, and therefore may have a potential to reverse PEW. The aim of this study is to investigate the effect of intra-dialytic progressive exercise training and adequate nutritional supplementation on markers of PEW, functional capacities and quality of life of adult hemodialysis patients.

METHODS AND DESIGN: Fifty end-stage renal disease patients undergoing hemodialysis, who meet the diagnostic criteria for PEW, will be randomly allocated into an exercise or control group for 6 months. The exercise consists of a progressive submaximal individualized cycling exertion using an adapted cycle ergometer, during the three weekly dialysis sessions. Biological markers of nutrition (albumin, prealbumin) will be followed monthly and all patients will be assessed for body composition, walk function, muscle strength, postural stability and quality of life at baseline and during the eighth week (t+2), the sixteenth week (t+4) and the twenty-fourth week (t+6) of the 6-month adapted rehabilitation program.

DISCUSSION: The successful completion of this current trial may give precious clues in understanding PEW and encourage nephrologists to extend prescription of exercise programs as well as therapeutic and as preventive interventions in this high-risk population.

TRIAL REGISTRATION: The protocol for this study was registered with the France Clinical Trials Registry NCT01813851.