Clinical trial NCT02806089: Determinants of Muscle Strength in Chronic Kidney Disease
Official title: Determinants of Muscle Strength in Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: chronic kidney disease
malnutrition inflammation atherogenesis syndrome
muscle strength
muscle mass
lean body mass
physical activity
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-06-20
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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)

Eligibility criteria: 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

Primary outcomes:
measure: Voluntary muscle strength evaluated by handheld dynamometer
timeFrame: 1 day
Secondary outcomes:
measure: Muscle mass estimated by creatinine index evaluation
timeFrame: 1 day
measure: Lean body mass evaluated by electrical bioimpedance analysis
timeFrame: 1 day
measure: Physical activity estimated using the "Voorrips" score questionnaire
timeFrame: 1 day
measure: C reactive protein level
timeFrame: 1 day
measure: Albumin level
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: AIDER
city: Montpellier
country: France
facility: GCS Help Lapeyronie, CHU Montpellier
city: Nîmes
country: France
facility: AIDER
Study officials:
affiliation: CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE
name: Jean-Paul CRISTOL, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.