Chronic Kidney DiseaseNCT02806089
Determinants of Muscle Strength in Chronic Kidney Disease
A study testing Handheld dynamometer, Creatinine index and Electrical bioimpedance analysis in people with Chronic Kidney Disease, run by University Hospital, Montpellier at 3 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Handheld dynamometer, Creatinine index and Electrical bioimpedance analysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 3 sitesFrance
- Study dates
- 4 Jan 2016to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- chronic kidney disease without extrarenal replacement therapy
- history of renal transplantation
Trial locations and contacts
3 sites in 1 country.
France3 sites
AIDER
Montpellier, 34295
GCS Help Lapeyronie, CHU Montpellier
Montpellier, 34295
AIDER
Nîmes, 30900
About this study
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
Read the 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)
- Conditions
- Chronic Kidney Disease
- Being tested
- Handheld dynamometer, Creatinine index, Electrical bioimpedance analysis, "Voorrips" score questionnaire, Inflammatory and nutritional status
- Keywords
- chronic kidney disease, malnutrition inflammation atherogenesis syndrome, muscle strength, muscle mass, lean body mass, physical activity
- Medical subject headings
- Renal Insufficiency, Chronic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Handheld dynamometerDevice
Evaluation of muscle strength
Creatinine indexBiological
Evaluation of muscle mass using plasma creatinine level
Electrical bioimpedance analysisDevice
Evaluation of lean body mass
"Voorrips" score questionnaireOther
Evaluation of physical activity
Inflammatory and nutritional statusBiological
Evaluation of C reactive protein and albumin
| Study group | Role | What they receive |
|---|---|---|
| Muscle strength | Experimental | 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. Receives: Device: Handheld dynamometer; Biological: Creatinine index; Device: Electrical bioimpedance analysis; Other: "Voorrips" score questionnaire; Biological: Inflammatory and nutritional status |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voluntary muscle strength evaluated by handheld dynamometer
data will be measured in Newton.meter
Measured: 1 day
Secondary outcomes (5)
Muscle mass estimated by creatinine index evaluation
data will be obtained from plasma creatinine level and will be expressed in milligram/kilogram/day)
Measured: 1 day
Lean body mass evaluated by electrical bioimpedance analysis
data will be expressed in kilogram
Measured: 1 day
Physical activity estimated using the "Voorrips" score questionnaire
the score represents the daily physical activity according to a validated scale
Measured: 1 day
C reactive protein level
the parameter will be measured in milligram/liter
Measured: 1 day
Albumin level
the parameter will be measured in gram/liter
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study start4 Jan 2016
- Primary completion14 Jun 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Paul CRISTOL, Prof, Principal investigator, CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02806089
- Sponsor's protocol ID
- UF9639
- Status last verified
- Jan 2017
- First submitted
- 6 Jun 2016
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Souweine JS, Kuster N, Chenine L, Rodriguez A, Patrier L, Morena M, Badia E, Chalabi L, Raynal N, Ohresser I, Leray-Moragues H, Mercier J, Hayot M, Le Quintrec M, Gouzi F, Cristol JP. Physical inactivity and protein energy wasting play independent roles in muscle weakness in maintenance haemodialysis patients. PLoS One. 2018 Aug 1;13(8):e0200061. doi: 10.1371/journal.pone.0200061. eCollection 2018.
PubMed 30067754
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Muscle Strength in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT02806089
- Acronym / sponsor ID
- UF9639
- Conditions
- Chronic Kidney Disease
- Keywords
- chronic kidney disease, malnutrition inflammation atherogenesis syndrome, muscle strength, muscle mass, lean body mass, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 4 Jan 2016 (actual)
- Primary completion
- 14 Jun 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 20 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Muscle strength | Experimental | Device: Handheld dynamometer, Biological: Creatinine index, Device: Electrical bioimpedance analysis, Other: "Voorrips" score questionnaire, Biological: Inflammatory and nutritional statussingle 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- chronic kidney disease without extrarenal replacement therapy
- history of renal transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Handheld dynamometerEvaluation of muscle strength | Device | Muscle strength |
| Creatinine indexEvaluation of muscle mass using plasma creatinine level | Biological | Muscle strength |
| Electrical bioimpedance analysisEvaluation of lean body mass | Device | Muscle strength |
| "Voorrips" score questionnaireEvaluation of physical activity | Other | Muscle strength |
| Inflammatory and nutritional statusEvaluation of C reactive protein and albumin | Biological | Muscle strength |
Primary outcome
Voluntary muscle strength evaluated by handheld dynamometer
Time frame: 1 day
data will be measured in Newton.meter
5 secondary outcomes
Muscle mass estimated by creatinine index evaluation
Time frame: 1 day
Lean body mass evaluated by electrical bioimpedance analysis
Time frame: 1 day
Physical activity estimated using the "Voorrips" score questionnaire
Time frame: 1 day
C reactive protein level
Time frame: 1 day
Albumin level
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
- Derived from this study: PubMed 30067754Souweine JS, Kuster N, Chenine L, Rodriguez A, Patrier L, Morena M, Badia E, Chalabi L, Raynal N, Ohresser I, Leray-Moragues H, Mercier J, Hayot M, Le Quintrec M, Gouzi F, Cristol JP. Physical inactivity and protein energy wasting play independent roles in muscle weakness in maintenance haemodialysis patients. PLoS One. 2018 Aug 1;13(8):e0200061. doi: 10.1371/journal.pone.0200061. eCollection 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Paul CRISTOL, Prof principal investigator
CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Handheld dynamometer, Creatinine index and Electrical bioimpedance analysis in people with Chronic Kidney Disease, run by University Hospital, Montpellier at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voluntary muscle strength evaluated by handheld dynamometer (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02806089, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2019.