Chronic Renal Failure, Hemodialysis Treatment, Protein-energy Wasting Clinical Trial
— ACTINUTOfficial 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.
| Status | Terminated |
| Enrollment | 21 |
| Est. completion date | November 2013 |
| Est. primary completion date | November 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | ECHO center ( confluent site ) | Nantes | |
| France | ECHO CENTER( St-Jacques) | Nantes |
| Lead Sponsor | Collaborator |
|---|---|
| Nantes University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of patients who correct the state of protein energy wasting in intervention group compared to a control group | at 6 months | No | |
| Secondary | Body composition (fat free mass), assessed by bioimpedance spectroscopy using the Body composition monitor (BCM) | at 3 months and at 6 months | No | |
| Secondary | Quadriceps strength measured by dynamometer | at 3 months and at 6 monts | No | |
| Secondary | Performance (distance and velocity) in the 6 minute walk test | at 3 months and 6 months | Yes | |
| Secondary | Postural balance as measured by a force platform | at 3 months and at 6 months | No | |
| Secondary | Quality of life as measured by the SF-36 test | at the 3 months and at 6 months | No | |
| Secondary | The number of hospitalization days | at the 3 months and the 6 months | No | |
| Secondary | The survival | at the 3 months and at the 6 months | Yes | |
| Secondary | The dosage of albumin | at the 3 months and at the 6 months | Yes | |
| Secondary | The dosage of prealbumin | at 3 months and 6 months | No |