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

NCT03998917 | Withdrawn

• 1 other identifier: CHM-2019/S8/02
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

Chronic Kidney Failure; Fatigue; Adapted Physical Activity

Outcome Measures

Primary Outcomes (1)

• Neuromuscular evaluation of force.

  Maximum force normalized by body mass, measured by a hand grip test with the dominant hand.

  1 day

Secondary Outcomes (7)

• Psychometric evaluation of fatigue

  1 day

• Quality of life impact of fatigue

  1 day

• Assessment of gait and balance

  1 day

• Assesment of lower limb functional strength

  1 day

• Assesment of walking speed

  1 day

Study Arms (2)

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

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

Interventions

Discrimination of neuromuscular alterations protocol 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.

Chronic Kidney Disease (CKD) Patients; Control cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centre Hospitalier le Mans: lead
• Le Mans Universite: collaborator

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency, Chronic; Fatigue

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Giorgina Piccoli, MD

  Centre Hospitalier Le Mans, Nephrology Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: June 26, 2019
• Study Start: September 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: December 31, 2020
• Last Updated: March 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share