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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01813851
First received: March 12, 2013
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Chronic Renal Failure, Hemodialysis Treatment, Protein-energy Wasting
Device: Exercise training in addition to nutritional support

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Number of patients who correct the state of protein energy wasting in intervention group compared to a control group [ Time Frame: at 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body composition (fat free mass), assessed by bioimpedance spectroscopy using the Body composition monitor (BCM) [ Time Frame: at 3 months and at 6 months ] [ Designated as safety issue: No ]
  • Quadriceps strength measured by dynamometer [ Time Frame: at 3 months and at 6 monts ] [ Designated as safety issue: No ]
  • Performance (distance and velocity) in the 6 minute walk test [ Time Frame: at 3 months and 6 months ] [ Designated as safety issue: Yes ]
  • Postural balance as measured by a force platform [ Time Frame: at 3 months and at 6 months ] [ Designated as safety issue: No ]
  • Quality of life as measured by the SF-36 test [ Time Frame: at the 3 months and at 6 months ] [ Designated as safety issue: No ]
  • The number of hospitalization days [ Time Frame: at the 3 months and the 6 months ] [ Designated as safety issue: No ]
  • The survival [ Time Frame: at the 3 months and at the 6 months ] [ Designated as safety issue: Yes ]
  • The dosage of albumin [ Time Frame: at the 3 months and at the 6 months ] [ Designated as safety issue: Yes ]
  • The dosage of prealbumin [ Time Frame: at 3 months and 6 months ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: March 2013
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Reck MOTOmed® Letto

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01813851

Locations
France
ECHO center ( confluent site )
Nantes, France
ECHO CENTER( St-Jacques)
Nantes, France
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Dan Hristea, Dr ECHO
  More Information

No publications provided by Nantes University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01813851     History of Changes
Other Study ID Numbers: RC12_0487
Study First Received: March 12, 2013
Last Updated: April 29, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:
Dialysis, Exercise, Protein Energy Wasting, Nutrition and Physical Fitness

Additional relevant MeSH terms:
Cachexia
Kidney Failure, Chronic
Renal Insufficiency
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 26, 2014