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

NCT ID: NCT03998917

Last Updated: 2020-03-25

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2020-12-31

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.

Conditions

Chronic Kidney Failure; Chronic Kidney Disease stage3; Chronic Kidney Disease, Stage 4 (Severe); Chronic Kidney Disease Stage 5; Fatigue

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Discrimination of neuromuscular alterations protocol

Intervention Type: DIAGNOSTIC_TEST

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.

Discrimination of neuromuscular alterations protocol

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Le Mans Universite

OTHER

Sponsor Role: collaborator

Centre Hospitalier le Mans

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giorgina Piccoli, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Le Mans, Nephrology Department

Other Identifiers

CHM-2019/S8/02

Identifier Type: -

Identifier Source: org_study_id