Relationship Between Neuromuscular Fatigue, Perceived Tiredness and Level Of Physical Activity of Patients Living With HIV (ACT PHY HIV)
Primary Purpose
HIV Seropositivity
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Neuromuscular tests
Sponsored by
About this trial
This is an interventional supportive care trial for HIV Seropositivity
Eligibility Criteria
Inclusion Criteria:
- HIV patient - PLHIV (person living with HIV)
- Patient aged between 40 and 60
- patient attended the Nice University Hospital
Exclusion Criteria:
- Patient refusing to sign informed consent
- Subjects with motor disabilities;
- Subjects incapable of answering questionnaires independently;
- Subjects with anosognosia;
- Subjects with contraindications to physical practice;
- Persons co-infected with HCV or HBV
- People with associated fatigue-associated comorbidity (renal disease, cancer, multiple sclerosis (Harmon et al., 2008)
- Women who have been pregnant or have given birth in the previous twelve months
- Subjects with contraindications to magnetic stimulation (hearing disorders or carriers of metallic material.
- Subjects under tutelage, under curatorship or under safeguard of justice;
- Persons deprived of their liberty (administrative or judicial).
- Persons hospitalized without consent
- Persons admitted to a health or social institution for purposes other than research
- Persons of legal age who are the object of a legal protection measure or who are unable to express their consent
Sites / Locations
- CHU de Nice
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Patients considered physically active
Patients considered physically inactive
Arm Description
Measures of strength and determination of neuromuscular fatigue
Measures of strength and determination of neuromuscular fatigue
Outcomes
Primary Outcome Measures
relationship between neuromuscular fatigue, perceived fatigue and the level of physical activity
Secondary Outcome Measures
Full Information
NCT ID
NCT03124914
First Posted
December 30, 2016
Last Updated
July 23, 2018
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT03124914
Brief Title
Relationship Between Neuromuscular Fatigue, Perceived Tiredness and Level Of Physical Activity of Patients Living With HIV
Acronym
ACT PHY HIV
Official Title
Relationship Between Neuromuscular Fatigue, Perceived Tiredness and Level Of Physical Activity of Patients Living With HIV
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
April 19, 2017 (Actual)
Primary Completion Date
April 19, 2018 (Actual)
Study Completion Date
June 12, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Seropositivity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients considered physically active
Arm Type
Active Comparator
Arm Description
Measures of strength and determination of neuromuscular fatigue
Arm Title
Patients considered physically inactive
Arm Type
Active Comparator
Arm Description
Measures of strength and determination of neuromuscular fatigue
Intervention Type
Other
Intervention Name(s)
Neuromuscular tests
Intervention Description
Neuromuscular tests
Primary Outcome Measure Information:
Title
relationship between neuromuscular fatigue, perceived fatigue and the level of physical activity
Time Frame
through study completion, 1 year after the start
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
HIV patient - PLHIV (person living with HIV)
Patient aged between 40 and 60
patient attended the Nice University Hospital
Exclusion Criteria:
Patient refusing to sign informed consent
Subjects with motor disabilities;
Subjects incapable of answering questionnaires independently;
Subjects with anosognosia;
Subjects with contraindications to physical practice;
Persons co-infected with HCV or HBV
People with associated fatigue-associated comorbidity (renal disease, cancer, multiple sclerosis (Harmon et al., 2008)
Women who have been pregnant or have given birth in the previous twelve months
Subjects with contraindications to magnetic stimulation (hearing disorders or carriers of metallic material.
Subjects under tutelage, under curatorship or under safeguard of justice;
Persons deprived of their liberty (administrative or judicial).
Persons hospitalized without consent
Persons admitted to a health or social institution for purposes other than research
Persons of legal age who are the object of a legal protection measure or who are unable to express their consent
Facility Information:
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06200
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Relationship Between Neuromuscular Fatigue, Perceived Tiredness and Level Of Physical Activity of Patients Living With HIV
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