Determinants of Muscle Strength in Chronic Kidney Disease
Primary Purpose
Chronic Kidney Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Handheld dynamometer
Creatinine index
Electrical bioimpedance analysis
"Voorrips" score questionnaire
Inflammatory and nutritional status
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Kidney Disease focused on measuring chronic kidney disease, malnutrition inflammation atherogenesis syndrome, muscle strength, muscle mass, lean body mass, physical activity
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
Sites / Locations
- AIDER
- GCS Help Lapeyronie, CHU Montpellier
- AIDER
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Muscle strength
Arm Description
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.
Outcomes
Primary Outcome Measures
Voluntary muscle strength evaluated by handheld dynamometer
data will be measured in Newton.meter
Secondary Outcome Measures
Muscle mass estimated by creatinine index evaluation
data will be obtained from plasma creatinine level and will be expressed in milligram/kilogram/day)
Lean body mass evaluated by electrical bioimpedance analysis
data will be expressed in kilogram
Physical activity estimated using the "Voorrips" score questionnaire
the score represents the daily physical activity according to a validated scale
C reactive protein level
the parameter will be measured in milligram/liter
Albumin level
the parameter will be measured in gram/liter
Full Information
NCT ID
NCT02806089
First Posted
June 6, 2016
Last Updated
February 26, 2019
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT02806089
Brief Title
Determinants of Muscle Strength in Chronic Kidney Disease
Official Title
Determinants of Muscle Strength in Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 4, 2016 (Actual)
Primary Completion Date
June 14, 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
chronic kidney disease, malnutrition inflammation atherogenesis syndrome, muscle strength, muscle mass, lean body mass, physical activity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Muscle strength
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Handheld dynamometer
Intervention Description
Evaluation of muscle strength
Intervention Type
Biological
Intervention Name(s)
Creatinine index
Intervention Description
Evaluation of muscle mass using plasma creatinine level
Intervention Type
Device
Intervention Name(s)
Electrical bioimpedance analysis
Intervention Description
Evaluation of lean body mass
Intervention Type
Other
Intervention Name(s)
"Voorrips" score questionnaire
Intervention Description
Evaluation of physical activity
Intervention Type
Biological
Intervention Name(s)
Inflammatory and nutritional status
Intervention Description
Evaluation of C reactive protein and albumin
Primary Outcome Measure Information:
Title
Voluntary muscle strength evaluated by handheld dynamometer
Description
data will be measured in Newton.meter
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Muscle mass estimated by creatinine index evaluation
Description
data will be obtained from plasma creatinine level and will be expressed in milligram/kilogram/day)
Time Frame
1 day
Title
Lean body mass evaluated by electrical bioimpedance analysis
Description
data will be expressed in kilogram
Time Frame
1 day
Title
Physical activity estimated using the "Voorrips" score questionnaire
Description
the score represents the daily physical activity according to a validated scale
Time Frame
1 day
Title
C reactive protein level
Description
the parameter will be measured in milligram/liter
Time Frame
1 day
Title
Albumin level
Description
the parameter will be measured in gram/liter
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Paul CRISTOL, Prof
Organizational Affiliation
CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE
Official's Role
Principal Investigator
Facility Information:
Facility Name
AIDER
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
GCS Help Lapeyronie, CHU Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
AIDER
City
Nîmes
ZIP/Postal Code
30900
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30067754
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.
Results Reference
derived
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Determinants of Muscle Strength in Chronic Kidney Disease
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