NCT04330807

Brief Summary

Chronic Kidney Disease (CKD) induces many metabolic troubles especially for the advanced CKD (stage 3b-5) patients and their prevalence and importance grow with the deterioration of the glomerular filtration rate (GFR). Among them, muscle wasting is common and multifactorial, partially explained by an imbalance between protein catabolism and synthesis. Muscular strength is also affected beyond the reduction of the lean body mass, resulting in profound fatigue. The present study seeks to quantify the prevalence of low muscular strength production (dynapenia) in a cohort of elderly patients with advanced CKD, through a maximal voluntary contraction (MVC) handgrip test compared to control data available in the literature, matched in term of age and sex. It also aims to investigate the link between the reported fatigue (subjective) and the evolution of the MVC, called critical force (fcrit) during a fatiguing task (objective fatigability).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 2, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

June 22, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

March 23, 2022

Status Verified

March 1, 2022

Enrollment Period

1.9 years

First QC Date

March 26, 2020

Last Update Submit

March 8, 2022

Conditions

Chronic Kidney Disease Stage 3BChronic Kidney Disease stage4Chronic Kidney Disease Stage 5Fatigue

Keywords

Neuromuscular abilitiesDynapeniaOver-60-year-old patients

Outcome Measures

Primary Outcomes (1)

  • DYNAPENIA

    The main outcome of the study is to defined the prevalence of dynapenia for advanced CKD elderly patients. Dynapenia will be established when the mean of the first three MVC of the protocol is lower compared to the reference values appaired for age and sex. For reference values of elderly, please see Ramírez-Vélez et al., (2019).

    1 day

Secondary Outcomes (3)

  • EMG signal

    1 day

  • Objective fatigue

    1 day

  • Subjective fatigue

    1 day

Other Outcomes (4)

  • Anthropometric data

    Within 3 months for the CKD patients, within 6 months for the control volunteers.

  • Clinical data

    Within 3 months for the CKD patients, within 6 months for the control volunteers.

  • Nutritional data

    Within 3 months for the CKD patients, within 6 months for the control volunteers.

  • +1 more other outcomes

Study Arms (2)

Patient with chronic kidney disease

OTHER

Patients will perform a Handgrip fatigability test with their dominant hand and will complete two questionnaires of assessment of subjective fatigue.

Other: Handgrip fatigability testOther: Questionnaires

CONTROL GROUP

OTHER

Patients will perform a Handgrip fatigability test with their dominant hand and will complete two questionnaires of assessment of subjective fatigue.

Other: Handgrip fatigability testOther: Questionnaires

Interventions

Handgrip fatigability testOTHER

Dynamometric and electromyographic assessment: patient is sitting on a chair, back upright, humerus vertically placed and forearm landing parallel to a support. Dominant arm is chosen for test and electrodes placement. The assessment is divided in 4 phases for a total of 30 minutes duration: Warm-up, determination of reference force settings (fast sub-maximal contractions and maximal voluntary contractions), fatigability period and rest.

CONTROL GROUPPatient with chronic kidney disease
QuestionnairesOTHER

Assessment of subjective fatigue with Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and Multidimensional Fatigue Inventory (MFI-20) questionnaires

CONTROL GROUPPatient with chronic kidney disease

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults, aged 60 and over
  • Social security coverage
  • Signed informed consent
  • For patient with Chronic Kidney Disease, estimated glomerular filtration rate (eGFR) less than 45ml/min/1.73m2 (Stage 3b) for at least 3 months
  • For patient with Chronic Kidney Disease, stable clinical condition (i.e., Creatinine increased by a maximum of 25% in the previous 3 months)
  • For control group, 1:1 recruitment with case matching with CDK patients on gender (i.e., male and female) and the presence of diabètes (i.e., presence and absence)
  • For control group, blood test with control of renal function available and dated less than 6 months: with eGFR \> 60ml/min/1.73m2 (and control of glucose or glycated hemoglobin for diabetic controls)

You may not qualify if:

  • Pregnant women
  • Under guardianship or minor
  • Neuromuscular disease
  • Dementia
  • Upper limbs history of surgery or pathologies preventing from fitting EMG electrodes or measuring handgrip force
  • Life expectancy of less than 3 months estimated by medical judgment
  • Programed hospitalization in the previous 3 months
  • Participation to another interventional clinical trial
  • Acute kidney disease
  • On dialysis or expected start of dialysis within next 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Du Mans

Le Mans, 72000, France

RECRUITING

Related Publications (1)

  • Chatrenet A, Beaune B, Fois A, Pouliquen C, Audebrand JM, Torreggiani M, Paris D, Durand S, Piccoli GB. PhysIOpathology of NEuromuscular function rElated to fatigue in chronic Renal disease in the elderly (PIONEER): study protocol. BMC Nephrol. 2020 Jul 25;21(1):305. doi: 10.1186/s12882-020-01976-6.

    PMID: 32711479DERIVED

MeSH Terms

Conditions

Renal Insufficiency, ChronicFatigue

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Christelle JADEAU

CONTACT

0033 2 43 43 43 43cjadeau@ch-lemans.fr

Giorgina PICCOLI, MD

CONTACT

0033 2 43 43 43 43gpiccoli@ch-lemans.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2020

First Posted

April 2, 2020

Study Start

June 22, 2020

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

March 23, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)