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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02806089
Other study ID # UF9639
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 4, 2016
Est. completion date October 2017

Study information

Verified date January 2017
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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)


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date October 2017
Est. primary completion date June 14, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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


Intervention

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

Locations

Country Name City State
France AIDER Montpellier
France GCS Help Lapeyronie, CHU Montpellier Montpellier
France AIDER Nîmes

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Voluntary muscle strength evaluated by handheld dynamometer data will be measured in Newton.meter 1 day
Secondary 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
Secondary Lean body mass evaluated by electrical bioimpedance analysis data will be expressed in kilogram 1 day
Secondary Physical activity estimated using the "Voorrips" score questionnaire the score represents the daily physical activity according to a validated scale 1 day
Secondary C reactive protein level the parameter will be measured in milligram/liter 1 day
Secondary Albumin level the parameter will be measured in gram/liter 1 day
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