Pathophysiological Characterization of the Neuromuscular Function of a Population With Multiple Comorbidities Suffering From Chronic Renal Failure in Pre-dialysis. (PIONNIER)

The evolution of chronic kidney disease (CKD) causes a systemic upheaval on the body and a deep fatigue is very often described by patients (50-70% of the patients) even before the start of dialysis (pre-dialysis). This fatigue has many origins, and one of them probably stems from a deterioration of neuromuscular abilities. Very few studies have examined the physiological aspects of neuromuscular fatigue in pre-dialysis patients, and shedding light on potential deficits at this level would allow safe and efficient implementation of adapted physical activity programs.

Our study aims to characterize the pathophysiology of neuromuscular capabilities in chronic advanced renal failure in pre-dialysis patients.

Study Overview

• Status: Withdrawn
• Conditions: Fatigue; Chronic Kidney Disease Stage 5; Chronic Kidney Disease stage3; Chronic Kidney Failure; Chronic Kidney Disease, Stage 4 (Severe)
• Intervention / Treatment: Diagnostic test: Discrimination of neuromuscular alterations protocol

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Chronic Kidney Disease (CKD) group:

Patients with chronic kidney disease and a glomerular filtration rate less than 60 ml/min of creatinine.

Control group:

The control group will consist of a group of people from the same age group as the CKD group but without chronic kidney disease. The exclusion criteria apply to this group. They will be selected from the spouses and other volunteers.

Description

Inclusion Criteria:

• Adult patients (Age> 18 years) who have signed the informed consent form
• Social security coverage
• For patients in the Chronic Kidney Disease group: Glomerular filtration rate less than 60 ml/min of creatinine for more than three months

Exclusion Criteria:

• Dermatological conditions of the upper limbs which would contra-indicate Electromyographic electrodes being positioned
• Gestating women
• Patients with known neuromuscular conditions
• Patients with dementia
• Patients with acute heart failure
• Patients with a history of surgery of the evaluated limb
• Patients included in an interventional study involving administration of treatments other than routine care
• For the patients in the Chronic Kidney Disease group: patients currently undergoing dialysis or in a pre-dialysis program (e.g. with a dialysis fistula already in place).

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chronic Kidney Disease (CKD) Patients; Patients with chronic kidney disease and a glomerular filtration rate less than 60 ml/min of creatinine. Patients will perform a hand grip fatigability test with their dominant hand, followed by a Timed Up and Go Test (TUG-Test), a Five-repetition sit-to-stand-test (5STS-Test) and a10 meters gait speed test.	Diagnostic test: Discrimination of neuromuscular alterations protocol; Patients will perform a hand grip fatigability test with their dominant hand, followed by a Timed Up and Go Test (TUG-Test), a Five-repetition sit-to-stand-test (5STS-Test) and a10 meters gait speed test.
Control cohort; The control cohort will consist of a group of people from the same age group as the CKD group but without chronic kidney disease. The exclusion criteria apply to this group. They will be selected from the spouses and other volunteers. This group will also perform a hand grip fatigability test with their dominant hand, followed by a Timed Up and Go Test (TUG-Test), a Five-repetition sit-to-stand-test (5STS-Test) and a10 meters gait speed test.	Diagnostic test: Discrimination of neuromuscular alterations protocol; Patients will perform a hand grip fatigability test with their dominant hand, followed by a Timed Up and Go Test (TUG-Test), a Five-repetition sit-to-stand-test (5STS-Test) and a10 meters gait speed test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuromuscular evaluation of force.	Maximum force normalized by body mass, measured by a hand grip test with the dominant hand.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychometric evaluation of fatigue	The Multidimensional Fatigue Inventory (MFI) is a 20 question self-report instrument designed to measure fatigue. It covers the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. Each question is graded from 1 ("Yes, that is true") to 5 ("No, that is not true"). Higher scores indicate a higher level of fatigue.	1 day
Quality of life impact of fatigue	The functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) evaluates the impact on quality of life of chronic illness. This is a questionnaire with 13 questions graded according to a Likert scale ranging from 1 to 5 (1 = quite, 5 = not at all).	1 day
Assessment of gait and balance	The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It measures the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.	1 day
Assesment of lower limb functional strength	The five-repetition sit-to-stand test (5STS) is a test of lower limb function that measures the fastest time taken to stand five times from a chair with arms folded.	1 day
Assesment of walking speed	10 meters gait speed test: measure of the time required to walk 10 meters at the fastest speed possible.	1 day
Electromyographic evaluation: temporal recruitment of the motor units.	The evolution of temporal recruitment through the evaluation of the discharge frequency of the motor units.	1 day
Electromyographic evaluation: Root Mean Square measurement	The average Root Mean Square (RMS) evolution according to the progress of the fatigability protocol, and its link with the developed force.	1 day

Collaborators and Investigators

• Sponsor: Centre Hospitalier le Mans
• Collaborators: Le Mans Universite
• Investigators: Principal Investigator: Giorgina Piccoli, MD, Centre Hospitalier Le Mans, Nephrology Department

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2019
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: June 24, 2019
• First Submitted That Met QC Criteria: June 24, 2019
• First Posted (Actual): June 26, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Fatigue; Chronic Kidney Failure; Adapted Physical Activity
• Additional Relevant MeSH Terms: Urologic Diseases; Fatigue; Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: CHM-2019/S8/02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No