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

Fatigue Clinical Trial

— PIONNIER  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03998917
• Other study ID #: CHM-2019/S8/02
• Status: Withdrawn
• Start date: September 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2020
• Source: Centre Hospitalier le Mans
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Kidney Disease Stage 5
• Chronic Kidney Disease stage3
• Chronic Kidney Disease, Stage 4 (Severe)
• Chronic Kidney Failure
• Fatigue
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier le Mans	Le Mans Université

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuromuscular evaluation of force.	Maximum force normalized by body mass, measured by a hand grip test with the dominant hand.	1 day
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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