Determinants of Muscle Strength in Chronic Kidney Disease

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

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • AIDER
  • Montpellier, France, 34295
    • GCS Help Lapeyronie, CHU Montpellier
  • Nîmes, France, 30900
    • AIDER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Muscle strength; 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 dynamometer; Evaluation of muscle strength; Biological: Creatinine index; Evaluation of muscle mass using plasma creatinine level; Device: Electrical bioimpedance analysis; Evaluation of lean body mass; Other: "Voorrips" score questionnaire; Evaluation of physical activity; Biological: Inflammatory and nutritional status; Evaluation of C reactive protein and albumin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Voluntary muscle strength evaluated by handheld dynamometer	data will be measured in Newton.meter	1 day

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2016
• Primary Completion (Actual): June 14, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: June 6, 2016
• First Submitted That Met QC Criteria: June 15, 2016
• First Posted (Estimate): June 20, 2016

Study Record Updates

• Last Update Posted (Actual): February 28, 2019
• Last Update Submitted That Met QC Criteria: February 26, 2019
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: physical activity; muscle strength; chronic kidney disease; muscle mass; lean body mass; malnutrition inflammation atherogenesis syndrome
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: UF9639

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO