Determinants of Muscle Strength in Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

Official title:

Determinants of Muscle Strength in Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02806089
• Other study ID #: UF9639
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

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