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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03998917
Other study ID # CHM-2019/S8/02
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date September 1, 2019
Est. completion date December 31, 2020

Study information

Verified date March 2020
Source Centre Hospitalier le Mans
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn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).

Study Design


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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Centre Hospitalier le Mans Le Mans Université

Outcome

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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