Fatigue Clinical Trial
— PIONNIEROfficial title:
Pathophysiological Characterization of the Neuromuscular Function of a Population With Multiple Comorbidities Suffering From Chronic Renal Failure in Pre-dialysis.
Verified date | March 2020 |
Source | Centre Hospitalier le Mans |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |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). |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier le Mans | Le Mans Université |
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 |
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