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

Nantes University Hospital (NUH)

Status: Terminated

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

Treatments: Device: Exercise training in addition to nutritional support

Study type: Interventional

Funder types: Other

Identifiers

NCT01813851

RC12_0487

Details and patient eligibility

About

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.

Full 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

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

control group

No Intervention group

Description:

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

activity group

Experimental group

Description:

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

Treatment:

Device: Exercise training in addition to nutritional support