Pathophysiological Characterization of the Neuromuscular Function of a Population With Multiple Comorbidities Suffering From Chronic Renal Failure in Pre-dialysis.
- Conditions
- Chronic Kidney Disease Stage 5Chronic Kidney Disease stage3FatigueChronic Kidney FailureChronic Kidney Disease, Stage 4 (Severe)
- Interventions
- Diagnostic Test: Discrimination of neuromuscular alterations protocol
- Registration Number
- NCT03998917
- Lead Sponsor
- Centre Hospitalier le Mans
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Chronic Kidney Disease (CKD) Patients Discrimination of neuromuscular alterations protocol 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. Control cohort Discrimination of neuromuscular alterations protocol 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.
- Primary Outcome Measures
Name Time Method Neuromuscular evaluation of force. 1 day Maximum force normalized by body mass, measured by a hand grip test with the dominant hand.
- Secondary Outcome Measures
Name Time Method Electromyographic evaluation: Root Mean Square measurement 1 day The average Root Mean Square (RMS) evolution according to the progress of the fatigability protocol, and its link with the developed force.
Assessment of gait and balance 1 day 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.
Assesment of lower limb functional strength 1 day 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.
Psychometric evaluation of fatigue 1 day 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.
Assesment of walking speed 1 day 10 meters gait speed test: measure of the time required to walk 10 meters at the fastest speed possible.
Electromyographic evaluation: temporal recruitment of the motor units. 1 day The evolution of temporal recruitment through the evaluation of the discharge frequency of the motor units.
Quality of life impact of fatigue 1 day 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).