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Trial record 73 of 10381 for:    strength

Determinants of Muscle Strength in Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT02806089
Recruitment Status : Completed
First Posted : June 20, 2016
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Device: Handheld dynamometer Biological: Creatinine index Device: Electrical bioimpedance analysis Other: "Voorrips" score questionnaire Biological: Inflammatory and nutritional status Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Determinants of Muscle Strength in Chronic Kidney Disease
Actual Study Start Date : January 4, 2016
Actual Primary Completion Date : June 14, 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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




Primary Outcome Measures :
  1. Voluntary muscle strength evaluated by handheld dynamometer [ Time Frame: 1 day ]
    data will be measured in Newton.meter


Secondary Outcome Measures :
  1. 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)

  2. Lean body mass evaluated by electrical bioimpedance analysis [ Time Frame: 1 day ]
    data will be expressed in kilogram

  3. Physical activity estimated using the "Voorrips" score questionnaire [ Time Frame: 1 day ]
    the score represents the daily physical activity according to a validated scale

  4. C reactive protein level [ Time Frame: 1 day ]
    the parameter will be measured in milligram/liter

  5. Albumin level [ Time Frame: 1 day ]
    the parameter will be measured in gram/liter



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02806089


Locations
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France
AIDER
Montpellier, France, 34295
GCS Help Lapeyronie, CHU Montpellier
Montpellier, France, 34295
AIDER
Nîmes, France, 30900
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Jean-Paul CRISTOL, Prof CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02806089     History of Changes
Other Study ID Numbers: UF9639
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Montpellier:
chronic kidney disease
malnutrition inflammation atherogenesis syndrome
muscle strength
muscle mass
lean body mass
physical activity
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency