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出境医 / 临床实验 / Pathophysiological Characterization of the Neuromuscular Function of a Population With Multiple Comorbidities Suffering From Chronic Renal Failure in Pre-dialysis. (PIONNIER)

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

Study Description
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.


Condition or disease Intervention/treatment
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 Design
Layout table for study information
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
Arms and Interventions
Group/Cohort Intervention/treatment
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
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.
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.

Outcome Measures
Primary Outcome Measures :
  1. Neuromuscular evaluation of force. [ Time Frame: 1 day ]
    Maximum force normalized by body mass, measured by a hand grip test with the dominant hand.


Secondary Outcome Measures :
  1. Psychometric evaluation of fatigue [ Time Frame: 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.

  2. Quality of life impact of fatigue [ Time Frame: 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).


  3. Assessment of gait and balance [ Time Frame: 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.

  4. Assesment of lower limb functional strength [ Time Frame: 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.

  5. Assesment of walking speed [ Time Frame: 1 day ]
    10 meters gait speed test: measure of the time required to walk 10 meters at the fastest speed possible.

  6. Electromyographic evaluation: temporal recruitment of the motor units. [ Time Frame: 1 day ]
    The evolution of temporal recruitment through the evaluation of the discharge frequency of the motor units.

  7. Electromyographic evaluation: Root Mean Square measurement [ Time Frame: 1 day ]
    The average Root Mean Square (RMS) evolution according to the progress of the fatigability protocol, and its link with the developed force.


Eligibility Criteria
Layout table for eligibility information
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
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.

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).
Contacts and Locations

Sponsors and Collaborators
Centre Hospitalier le Mans
Le Mans Universite
Investigators
Layout table for investigator information
Principal Investigator: Giorgina Piccoli, MD Centre Hospitalier Le Mans, Nephrology Department
Tracking Information
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
 (submitted: June 24, 2019)
Neuromuscular evaluation of force. [ Time Frame: 1 day ]
Maximum force normalized by body mass, measured by a hand grip test with the dominant hand.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 26, 2019)
  • Psychometric evaluation of fatigue [ Time Frame: 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.
  • Quality of life impact of fatigue [ Time Frame: 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).
  • Assessment of gait and balance [ Time Frame: 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 [ Time Frame: 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.
  • Assesment of walking speed [ Time Frame: 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. [ Time Frame: 1 day ]
    The evolution of temporal recruitment through the evaluation of the discharge frequency of the motor units.
  • Electromyographic evaluation: Root Mean Square measurement [ Time Frame: 1 day ]
    The average Root Mean Square (RMS) evolution according to the progress of the fatigability protocol, and its link with the developed force.
Original Secondary Outcome Measures
 (submitted: June 24, 2019)
  • Psychometric evaluation of fatigue [ Time Frame: 1 day ]
    The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity.
  • Quality of life impact of fatigue [ Time Frame: 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).
  • Assessment of gait and balance [ Time Frame: 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 [ Time Frame: 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.
  • Assesment of walking speed [ Time Frame: 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. [ Time Frame: 1 day ]
    The evolution of temporal recruitment through the evaluation of the discharge frequency of the motor units.
  • Electromyographic evaluation: Root Mean Square measurement [ Time Frame: 1 day ]
    The average Root Mean Square (RMS) evolution according to the progress of the fatigability protocol, and its link with the developed force.
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
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.

Condition
  • Chronic Kidney Failure
  • Chronic Kidney Disease stage3
  • Chronic Kidney Disease, Stage 4 (Severe)
  • Chronic Kidney Disease Stage 5
  • Fatigue
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.
Study Groups/Cohorts
  • 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.
    Intervention: 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.
    Intervention: Diagnostic Test: Discrimination of neuromuscular alterations protocol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: March 23, 2020)
0
Original Estimated Enrollment
 (submitted: June 24, 2019)
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:

  • 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).
Sex/Gender
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Centre Hospitalier le Mans
Study Sponsor Centre Hospitalier le Mans
Collaborators Le Mans Universite
Investigators
Principal Investigator: Giorgina Piccoli, MD Centre Hospitalier Le Mans, Nephrology Department
PRS Account Centre Hospitalier le Mans
Verification Date March 2020