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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
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV Seropositivity

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

First Posted
December 30, 2016
Last Updated
July 23, 2018
Sponsor
Centre Hospitalier Universitaire de Nice
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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

Learn more about this trial

Relationship Between Neuromuscular Fatigue, Perceived Tiredness and Level Of Physical Activity of Patients Living With HIV

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