Ignite Creation Date:
2024-05-06 @ 9:58 AM
Last Modification Date:
2024-10-26 @ 12:22 PM
Study NCT ID:
NCT03124914
Status:
COMPLETED
Last Update Posted:
2018-07-24
First Post:
2016-12-30
Brief Title:
Relationship Between Neuromuscular Fatigue Perceived Tiredness and Level Of Physical Activity of Patients Living With HIV
Sponsor:
Centre Hospitalier Universitaire de Nice
Organization:
Centre Hospitalier Universitaire de Nice
Study Overview
Official Title:
Relationship Between Neuromuscular Fatigue Perceived Tiredness and Level Of Physical Activity of Patients Living With HIV
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACT PHY HIV
Brief Summary:
Fatigue is a common symptom in people living with HIV PHAs that affects all aspects of life This would include physical deconditioning a reduction in motor skills Numerous studies show that physical activity brings benefits for the quality of life of PHAs However due to the predominantly reported fatigue many PHAs are not physically active enough in relation to these recommendations While it is recognized that fatigue is predominant in PHAs this complaint has mainly been subjectively quantified and has rarely been physically objectified a better understanding of the relationship between neuromuscular fatigue perceived fatigue and the level of physical activity of PHAs is needed in line with current work on integrating fatigue
OBJECTIVES This project based on an integrative eg neurophysiological and psychological approach to fatigue aims to better explain and prevent the vicious circle of physical deconditioning in PHAs by examining the relationships between neuromuscular fatigue perceived fatigue Physical activity of patients
The main objective of the study will be to compare the characteristics of neuromuscular fatigue in physically active or inactive PHAs
The secondary objective will be to examine the relationship between neuromuscular fatigue level of physical activity and perceived physical fatigue of PHAs
CONDUCT OF THE STUDY Cross-sectional comparative study without individual benefit for the patient Monocentric test to quantify and relate neuromuscular fatigue perceived physical fatigue and physical activity level The main inclusion criteria for this study are PLHIV aged between 40 and 60 Diagnosed and treated with antivirals after 1996 irrespective of the value of the viral load and CD4 lymphocyte level at the last assessment The physical activity level of the patients will be evaluated before the start of the study in order to constitute two distinct groups
Principal evaluation criterion Investigation of the neurophysiological characteristics of fatigue will be done by recording the capacity to produce force at the level of the extensor muscles of the knee under conditions of voluntary contractions and evoked by magnetic stimulation at the level of Femoral nerve
Secondary evaluation criteria the investigation of the perceived fatigue will be done by a valid psychometric questionnaire
OBJECTIVES This project based on an integrative eg neurophysiological and psychological approach to fatigue aims to better explain and prevent the vicious circle of physical deconditioning in PHAs by examining the relationships between neuromuscular fatigue perceived fatigue Physical activity of patients
The main objective of the study will be to compare the characteristics of neuromuscular fatigue in physically active or inactive PHAs
The secondary objective will be to examine the relationship between neuromuscular fatigue level of physical activity and perceived physical fatigue of PHAs
CONDUCT OF THE STUDY Cross-sectional comparative study without individual benefit for the patient Monocentric test to quantify and relate neuromuscular fatigue perceived physical fatigue and physical activity level The main inclusion criteria for this study are PLHIV aged between 40 and 60 Diagnosed and treated with antivirals after 1996 irrespective of the value of the viral load and CD4 lymphocyte level at the last assessment The physical activity level of the patients will be evaluated before the start of the study in order to constitute two distinct groups
Principal evaluation criterion Investigation of the neurophysiological characteristics of fatigue will be done by recording the capacity to produce force at the level of the extensor muscles of the knee under conditions of voluntary contractions and evoked by magnetic stimulation at the level of Femoral nerve
Secondary evaluation criteria the investigation of the perceived fatigue will be done by a valid psychometric questionnaire
Detailed Description:
RATIONAL Fatigue is a common symptom in people living with HIV PHAs that affects all aspects of life This would include physical deconditioning a reduction in motor skills Numerous studies show that physical activity brings benefits for the quality of life of PHAs However due to the predominantly reported fatigue many PHAs are not physically active enough in relation to these recommendations While it is recognized that fatigue is predominant in PHAs this complaint has mainly been subjectively quantified and has rarely been physically objectified a better understanding of the relationship between neuromuscular fatigue perceived fatigue and the level of physical activity of PHAs is needed in line with current work on integrating fatigue
OBJECTIVES OF THE STUDY This project based on an integrative eg neurophysiological and psychological approach to fatigue aims to better explain and prevent the vicious circle of physical deconditioning in PHAs by examining the relationships between neuromuscular fatigue perceived fatigue Physical activity of patients
The main objective of the study will be to compare the characteristics of neuromuscular fatigue in physically active or inactive PHAs
The secondary objective will be to examine the relationship between neuromuscular fatigue level of physical activity and perceived physical fatigue of PHAs
CONDUCT OF THE STUDY Cross-sectional comparative study without individual benefit for the patient Monocentric test to quantify and relate neuromuscular fatigue perceived physical fatigue and physical activity level The main inclusion criteria for this study are PLHIV aged between 40 and 60 Diagnosed and treated with antivirals after 1996 irrespective of the value of the viral load and CD4 lymphocyte level at the last assessment The physical activity level of the patients will be evaluated before the start of the study in order to constitute two distinct groups a a group of patients considered as physically active SAP 22 and b a group of patients considered as Physically inactive SAP 15 Confirmed by blood diagnosis Those who have recently stopped their antiretroviral treatment and or their medical follow-up and who have a progressive recovery of their infection and those affected by other health conditions marked by fatigue will be excluded
Principal evaluation criterion Investigation of the neurophysiological characteristics of fatigue will be done by recording the capacity to produce force at the level of the extensor muscles of the knee under conditions of voluntary contractions and evoked by magnetic stimulation at the level of Femoral nerve
Secondary evaluation criteria the investigation of the perceived fatigue will be done by a valid psychometric questionnaire
OBJECTIVES OF THE STUDY This project based on an integrative eg neurophysiological and psychological approach to fatigue aims to better explain and prevent the vicious circle of physical deconditioning in PHAs by examining the relationships between neuromuscular fatigue perceived fatigue Physical activity of patients
The main objective of the study will be to compare the characteristics of neuromuscular fatigue in physically active or inactive PHAs
The secondary objective will be to examine the relationship between neuromuscular fatigue level of physical activity and perceived physical fatigue of PHAs
CONDUCT OF THE STUDY Cross-sectional comparative study without individual benefit for the patient Monocentric test to quantify and relate neuromuscular fatigue perceived physical fatigue and physical activity level The main inclusion criteria for this study are PLHIV aged between 40 and 60 Diagnosed and treated with antivirals after 1996 irrespective of the value of the viral load and CD4 lymphocyte level at the last assessment The physical activity level of the patients will be evaluated before the start of the study in order to constitute two distinct groups a a group of patients considered as physically active SAP 22 and b a group of patients considered as Physically inactive SAP 15 Confirmed by blood diagnosis Those who have recently stopped their antiretroviral treatment and or their medical follow-up and who have a progressive recovery of their infection and those affected by other health conditions marked by fatigue will be excluded
Principal evaluation criterion Investigation of the neurophysiological characteristics of fatigue will be done by recording the capacity to produce force at the level of the extensor muscles of the knee under conditions of voluntary contractions and evoked by magnetic stimulation at the level of Femoral nerve
Secondary evaluation criteria the investigation of the perceived fatigue will be done by a valid psychometric questionnaire
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None