Determinants of Muscle Strength in Chronic Kidney Disease
February 26, 2019 updated by: University Hospital, Montpellier
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
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Montpellier, France, 34295
- AIDER
-
Montpellier, France, 34295
- GCS Help Lapeyronie, CHU Montpellier
-
Nîmes, France, 30900
- AIDER
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
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.
|
Evaluation of muscle strength
Evaluation of muscle mass using plasma creatinine level
Evaluation of lean body mass
Evaluation of physical activity
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
Time Frame: 1 day
|
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
Time Frame: 1 day
|
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
Time Frame: 1 day
|
data will be expressed in kilogram
|
1 day
|
|
Physical activity estimated using the "Voorrips" score questionnaire
Time Frame: 1 day
|
the score represents the daily physical activity according to a validated scale
|
1 day
|
|
C reactive protein level
Time Frame: 1 day
|
the parameter will be measured in milligram/liter
|
1 day
|
|
Albumin level
Time Frame: 1 day
|
the parameter will be measured in gram/liter
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- UF9639
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.