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

April 29, 2014 updated by: Nantes University Hospital

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France
        • ECHO center ( confluent site )
      • Nantes, France
        • ECHO CENTER( St-Jacques)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: control group

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

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
Other Names:
  • Reck MOTOmed® Letto

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Body composition (fat free mass), assessed by bioimpedance spectroscopy using the Body composition monitor (BCM)
Time Frame: at 3 months and at 6 months
at 3 months and at 6 months
Quadriceps strength measured by dynamometer
Time Frame: at 3 months and at 6 monts
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
at 3 months and 6 months
Postural balance as measured by a force platform
Time Frame: at 3 months and at 6 months
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
at the 3 months and at 6 months
The number of hospitalization days
Time Frame: at the 3 months and the 6 months
at the 3 months and the 6 months
The survival
Time Frame: at the 3 months and at the 6 months
at the 3 months and at the 6 months
The dosage of albumin
Time Frame: at the 3 months and at the 6 months
at the 3 months and at the 6 months
The dosage of prealbumin
Time Frame: at 3 months and 6 months
at 3 months and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Dan Hristea, Dr, ECHO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ACTUAL)

November 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

March 12, 2013

First Submitted That Met QC Criteria

March 14, 2013

First Posted (ESTIMATE)

March 19, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 30, 2014

Last Update Submitted That Met QC Criteria

April 29, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC12_0487

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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