Chronic Kidney Disease Clinical Trial
Official title:
Determinants of Muscle Strength in Chronic Kidney Disease
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 |
Verified date | January 2017 |
Source | University Hospital, Montpellier |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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 |
Country | Name | City | State |
---|---|---|---|
France | AIDER | Montpellier | |
France | GCS Help Lapeyronie, CHU Montpellier | Montpellier | |
France | AIDER | Nîmes |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
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 |
Status | Clinical Trial | Phase | |
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