NCT02806089

Brief Summary

Aim of this study is to determine in chronic kidney disease patients:

  • the involvement of malnutrition inflammation and atherogenesis syndrome (increase in C reactive protein and decrease in serum albumin) on voluntary muscle strength impairment
  • the relationship between voluntary muscle strength and muscle mass
  • the relationship between voluntary muscle strength and lean body mass
  • the correlation between voluntary muscle strength and physical activity

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 20, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

February 28, 2019

Status Verified

January 1, 2017

Enrollment Period

1.4 years

First QC Date

June 6, 2016

Last Update Submit

February 26, 2019

Conditions

Chronic Kidney Disease

Keywords

chronic kidney diseasemalnutrition inflammation atherogenesis syndromemuscle strengthmuscle masslean body massphysical activity

Outcome Measures

Primary Outcomes (1)

  • Voluntary muscle strength evaluated by handheld dynamometer

    data will be measured in Newton.meter

    1 day

Secondary Outcomes (5)

  • Muscle mass estimated by creatinine index evaluation

    1 day

  • Lean body mass evaluated by electrical bioimpedance analysis

    1 day

  • Physical activity estimated using the "Voorrips" score questionnaire

    1 day

  • C reactive protein level

    1 day

  • Albumin level

    1 day

Study Arms (1)

Muscle strength

EXPERIMENTAL

single evaluation (the day of inclusion) of muscle strength (by handheld dynamometer), muscle mass (by creatinine index estimation), lean body mass (by electrical bioimpedance analysis), physical activity (by "Voorrips" score questionnaire), inflammatory and nutritional status.

Device: Handheld dynamometerBiological: Creatinine indexDevice: Electrical bioimpedance analysisOther: "Voorrips" score questionnaireBiological: Inflammatory and nutritional status

Interventions

Handheld dynamometerDEVICE

Evaluation of muscle strength

Muscle strength
Creatinine indexBIOLOGICAL

Evaluation of muscle mass using plasma creatinine level

Muscle strength
Electrical bioimpedance analysisDEVICE

Evaluation of lean body mass

Muscle strength
"Voorrips" score questionnaireOTHER

Evaluation of physical activity

Muscle strength
Inflammatory and nutritional statusBIOLOGICAL

Evaluation of C reactive protein and albumin

Muscle strength

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic kidney disease patient with extrarenal replacement therapy by hemodialysis for at least 3 months
  • stable clinical condition (absence of infection, stroke or acute decompensation)

You may not qualify if:

  • chronic kidney disease without extrarenal replacement therapy
  • history of renal transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

AIDER

Montpellier, 34295, France

Location

GCS Help Lapeyronie, CHU Montpellier

Montpellier, 34295, France

Location

AIDER

Nîmes, 30900, France

Location

Related Publications (1)

  • Souweine JS, Kuster N, Chenine L, Rodriguez A, Patrier L, Morena M, Badia E, Chalabi L, Raynal N, Ohresser I, Leray-Moragues H, Mercier J, Hayot M, Le Quintrec M, Gouzi F, Cristol JP. Physical inactivity and protein energy wasting play independent roles in muscle weakness in maintenance haemodialysis patients. PLoS One. 2018 Aug 1;13(8):e0200061. doi: 10.1371/journal.pone.0200061. eCollection 2018.

    PMID: 30067754DERIVED

MeSH Terms

Conditions

Renal Insufficiency, ChronicMotor Activity

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics

Study Officials

  • Jean-Paul CRISTOL, Prof

    CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2016

First Posted

June 20, 2016

Study Start

January 4, 2016

Primary Completion

June 14, 2017

Study Completion

October 1, 2017

Last Updated

February 28, 2019

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)