Clinical trial NCT01813851: Effect of Intradialytic Physical ACTIvity in Addition to a NUTritional Support on Protein Energy Wasting and Physical Functioning in Chronic Hemodialysis Patients ("ACTINUT" Study)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Renal Failure, Hemodialysis Treatment, Protein-energy Wasting
Keywords: Dialysis, Exercise, Protein Energy Wasting, Nutrition and Physical Fitness
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2013-03-19
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients who correct the state of protein energy wasting in intervention group compared to a control group
timeFrame: at 6 months
Secondary outcomes:
measure: Body composition (fat free mass), assessed by bioimpedance spectroscopy using the Body composition monitor (BCM)
timeFrame: at 3 months and at 6 months
measure: Quadriceps strength measured by dynamometer
timeFrame: at 3 months and at 6 monts
measure: Performance (distance and velocity) in the 6 minute walk test
timeFrame: at 3 months and 6 months
measure: Postural balance as measured by a force platform
timeFrame: at 3 months and at 6 months
measure: Quality of life as measured by the SF-36 test
timeFrame: at the 3 months and at 6 months
measure: The number of hospitalization days
timeFrame: at the 3 months and the 6 months
measure: The survival
timeFrame: at the 3 months and at the 6 months
measure: The dosage of albumin
timeFrame: at the 3 months and at the 6 months
measure: The dosage of prealbumin
timeFrame: at 3 months and 6 months
Other outcomes:
Locations:
city: Nantes
country: France
facility: ECHO center ( confluent site )
city: Nantes
country: France
facility: ECHO CENTER( St-Jacques)
Study officials:
affiliation: ECHO
name: Dan Hristea, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.
citation: Mah JY, Choy SW, Roberts MA, Desai AM, Corken M, Gwini SM, McMahon LP. Oral protein-based supplements versus placebo or no treatment for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 May 11;5(5):CD012616. doi: 10.1002/14651858.CD012616.pub2.
citation: Magnard J, Deschamps T, Cornu C, Paris A, Hristea D. 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. BMC Nephrol. 2013 Nov 26;14:259. doi: 10.1186/1471-2369-14-259.