Effect of Intradialytic Physical ACTIvity in Addition to a NUTritional Support on Protein Energy Wasting and Physical Functioning in Chronic Hemodialysis Patients (ACTINUT Study)

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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

Conditions
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Chronic Renal Failure, Hemodialysis Treatment, Protein-energy Wasting

Intervention / Treatment
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* Device: Exercise training in addition to nutritional support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged >18 years, treated by hemodialysis since more than 3 months Patients considered to be in a clinical stable state, defined as the absence of acute disease or hospitalization during the last month prior to study begin Patients fulfilling the diagnostic criteria of protein energy wasting according to the definition proposed by the International Society of Renal Nutrition and Metabolism (ISRNM) Patients having signed the informed consent for the study participation Patients covered by medical insurance Exclusion Criteria: Medical contraindication or inability to perform physical exercise Inadequate dialysis (KT/V< 1.2) Poor hemodynamic tolerance of dialysis Systemic inflammation (CRP >20 mg/l) Pregnancy Major trust

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>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 | |
| Experimental: activity group<br>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<br> <br> * Other names: Reck MOTOmed® Letto;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who correct the state of protein energy wasting in intervention group compared to a control group |  | at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition (fat free mass), assessed by bioimpedance spectroscopy using the Body composition monitor (BCM) |  | at 3 months and at 6 months | 
| Quadriceps strength measured by dynamometer |  | at 3 months and at 6 monts | 
| Performance (distance and velocity) in the 6 minute walk test |  | at 3 months and 6 months | 
| Postural balance as measured by a force platform |  | at 3 months and at 6 months | 
| Quality of life as measured by the SF-36 test |  | at the 3 months and at 6 months | 
| The number of hospitalization days |  | at the 3 months and the 6 months | 
| The survival |  | at the 3 months and at the 6 months | 
| The dosage of albumin |  | at the 3 months and at the 6 months | 
| The dosage of prealbumin |  | at 3 months and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dialysis, Exercise, Protein Energy Wasting, Nutrition and Physical Fitness