An interventional study of Exercise training in addition to nutritional support in Chronic Renal Failure, Hemodialysis Treatment, Protein-energy Wasting, sponsored by Nantes University Hospital. Terminated at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-30.
Sponsored by Nantes University Hospital · Not applicable, Interventional, and Treatment
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
2,121 studies on the registry are indexed under Kidney Failure, Chronic; 264 are open to participants now.
This study's enrollment of 21 is below the median of 55 across 1,582 interventional studies indexed under Kidney Failure, Chronic.
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Exclusion Criteria:
Patients in the "control group" will receive: Dietary counseling by a dietician and if necessary modification of the prescription of oral nutritional supplements or intradialytic parenteral nutrition to reach recommended targets according to the European Best Practice Guidelines on Nutrition (energy intake 30-40 kcal/kg of ideal weight/day, protein intake 1.1 g/kg of ideal weight/day
Patients in the "group exercise" will: Dietary counseling by a dietician and if necessary modification of the prescription of oral nutritional supplements or intradialytic parenteral nutrition to reach recommended targets according to the European Best Practice Guidelines on Nutrition (energy intake 30-40 kcal/kg of ideal weight/day, protein intake 1.1 g/kg of ideal weight/day A program of physical activity consisting of progressive endurance and resistance training on a cycle ergometer, performed during the dialysis session under supervision and counseling by a qualified trainer
Device: Exercise training in addition to nutritional support
Also known as: Reck MOTOmed® Letto
Number of patients who correct the state of protein energy wasting in intervention group compared to a control group
Time frame: at 6 months
Body composition (fat free mass), assessed by bioimpedance spectroscopy using the Body composition monitor (BCM)
Time frame: at 3 months and at 6 months
Quadriceps strength measured by dynamometer
Time frame: at 3 months and at 6 monts
Performance (distance and velocity) in the 6 minute walk test
Time frame: at 3 months and 6 months
Postural balance as measured by a force platform
Time frame: at 3 months and at 6 months
Quality of life as measured by the SF-36 test
Time frame: at the 3 months and at 6 months
The number of hospitalization days
Time frame: at the 3 months and the 6 months
The survival
Time frame: at the 3 months and at the 6 months
The dosage of albumin
Time frame: at the 3 months and at the 6 months
The dosage of prealbumin
Time frame: at 3 months and 6 months
This study is terminated, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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