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.
Condition or disease | Intervention/treatment |
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Chronic Kidney Failure Chronic Kidney Disease stage3 Chronic Kidney Disease, Stage 4 (Severe) Chronic Kidney Disease Stage 5 Fatigue | Diagnostic Test: Discrimination of neuromuscular alterations protocol |
Study Type : | Observational |
Actual Enrollment : | 0 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Pathophysiological Characterization of the Neuromuscular Function of a Population With Multiple Comorbidities Suffering From Chronic Renal Failure in Pre-dialysis. |
Estimated Study Start Date : | September 1, 2019 |
Estimated Primary Completion Date : | September 1, 2020 |
Estimated Study Completion Date : | December 31, 2020 |
Group/Cohort | Intervention/treatment |
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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.
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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.
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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.
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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.
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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).
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Giorgina Piccoli, MD | Centre Hospitalier Le Mans, Nephrology Department |
Tracking Information | |||||
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First Submitted Date | June 24, 2019 | ||||
First Posted Date | June 26, 2019 | ||||
Last Update Posted Date | March 25, 2020 | ||||
Estimated Study Start Date | September 1, 2019 | ||||
Estimated Primary Completion Date | September 1, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Neuromuscular evaluation of force. [ Time Frame: 1 day ] Maximum force normalized by body mass, measured by a hand grip test with the dominant hand.
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Pathophysiological Characterization of the Neuromuscular Function of a Population With Multiple Comorbidities Suffering From Chronic Renal Failure in Pre-dialysis. | ||||
Official Title | Pathophysiological Characterization of the Neuromuscular Function of a Population With Multiple Comorbidities Suffering From Chronic Renal Failure in Pre-dialysis. | ||||
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. |
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Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
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. |
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Condition |
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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.
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Withdrawn | ||||
Actual Enrollment |
0 | ||||
Original Estimated Enrollment |
70 | ||||
Estimated Study Completion Date | December 31, 2020 | ||||
Estimated Primary Completion Date | September 1, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03998917 | ||||
Other Study ID Numbers | CHM-2019/S8/02 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Centre Hospitalier le Mans | ||||
Study Sponsor | Centre Hospitalier le Mans | ||||
Collaborators | Le Mans Universite | ||||
Investigators |
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PRS Account | Centre Hospitalier le Mans | ||||
Verification Date | March 2020 |