Determinants of Muscle Strength in Chronic Kidney Disease

Not Applicable

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Device: Handheld dynamometer; Biological: Creatinine index; Device: Electrical bioimpedance analysis; Other: "Voorrips" score questionnaire; Biological: Inflammatory and nutritional status

• Registration Number: NCT02806089
• Lead Sponsor: University Hospital, Montpellier

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

Detailed Description

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 (estimated by handheld dynamometer)

* the relationship between voluntary muscle strength and muscle mass (estimated by creatinine index)

* the relationship between voluntary muscle strength and lean body mass (estimated by bioelectrical impedance analysis)

* the correlation between voluntary muscle strength and physical activity (the physical activity being estimated by the "Voorrips" score questionnaire)

Study Timeline

• Study Start: 2016-01-04
• Study First Submitted: 2016-06-06
• Study First Submitted QC: 2016-06-15
• Study First Posted: 2016-06-20
• Status Verified: 2017-01
• Primary Completion: 2017-06-14
• Study Completion: 2017-10
• Last Update Submitted: 2019-02-26
• Last Update Posted: 2019-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• 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)

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Muscle strength	"Voorrips" score questionnaire	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.
Muscle strength	Handheld dynamometer	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.
Muscle strength	Electrical bioimpedance analysis	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.
Muscle strength	Inflammatory and nutritional status	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.
Muscle strength	Creatinine index	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.

Primary Outcome Measures

Name	Time	Method
Voluntary muscle strength evaluated by handheld dynamometer	1 day	data will be measured in Newton.meter

Secondary Outcome Measures

Name	Time	Method
Lean body mass evaluated by electrical bioimpedance analysis	1 day	data will be expressed in kilogram
Physical activity estimated using the "Voorrips" score questionnaire	1 day	the score represents the daily physical activity according to a validated scale
C reactive protein level	1 day	the parameter will be measured in milligram/liter
Albumin level	1 day	the parameter will be measured in gram/liter
Muscle mass estimated by creatinine index evaluation	1 day	data will be obtained from plasma creatinine level and will be expressed in milligram/kilogram/day)

Trial Locations

Locations (2)

AIDER; 🇫🇷 Nîmes, France

GCS Help Lapeyronie, CHU Montpellier; 🇫🇷 Montpellier, France