- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03124914
Relationship Between Neuromuscular Fatigue, Perceived Tiredness and Level Of Physical Activity of Patients Living With HIV (ACT PHY HIV)
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Nice, Frankrig, 06200
- CHU de Nice
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Patients considered physically active
Measures of strength and determination of neuromuscular fatigue
|
Neuromuscular tests
|
|
Aktiv komparator: Patients considered physically inactive
Measures of strength and determination of neuromuscular fatigue
|
Neuromuscular tests
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
relationship between neuromuscular fatigue, perceived fatigue and the level of physical activity
Tidsramme: through study completion, 1 year after the start
|
through study completion, 1 year after the start
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 16-PP-05
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med HIV seropositivitet
-
Duke UniversityGilead SciencesRekrutteringHIV-forebyggelse | HIV præ-eksponeringsprofylakse | HIV forebyggelsesprogram | HIV-forebyggelse og pleje | HIV Pre-eksponering profylakse brugForenede Stater
-
Federal University of São PauloGilead SciencesAfsluttet
-
University of Alabama at BirminghamMobile County Health Deparment; Alabama Department of Public HealthRekrutteringHIV | HIV-testning | HIV-kobling til pleje | HIV behandlingForenede Stater
-
University of Alabama at BirminghamNational Institute of Mental Health (NIMH)RekrutteringForbered | HIV | HIV-forebyggelse | PrEP optagelseForenede Stater
-
Institute of HIV Research and Innovation Foundation...National Institutes of Health (NIH)RekrutteringHIV-forebyggelse | PrEP overholdelse | HIV-relateret stigmaThailand
-
French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS FoundationAfsluttetPartner HIV-testning | Par HIV Rådgivning | Parkommunikation | HIV-forekomstCameroun, Dominikanske republik, Georgien, Indien
-
Massachusetts General HospitalNational Institute of Mental Health (NIMH)RekrutteringGennemførlighed | HIV-forebyggelse | PrEP optagelse | Acceptabilitet | HIV Selvtest | Mandlige partnere af HIV-negative postpartum-kvinderSydafrika
-
ANRS, Emerging Infectious DiseasesHopital Universitaire Robert-Debre; Institut de Recherche pour le Developpement og andre samarbejdspartnereUkendtHIV | HIV-uinficerede børn | Børn udsat for HIVCameroun
-
Instituto Mexicano del Seguro SocialRekrutteringVægttab | HIV | HIV-1 infektion | Vægtændring | HIV-associeret vægttab | Integrasehæmmere, HIV; HIV PROTEASE HÆMMERMexico
-
University of PennsylvaniaNational Institute of Mental Health (NIMH); University of BotswanaRekrutteringGraviditet | HIV | Efter fødslen | HIV antiretroviral terapi (ART) overholdelseBotswana
Kliniske forsøg med Neuromuscular tests
-
Logan College of ChiropracticAfsluttet
-
Imperial College LondonAfsluttet
-
Peking Union Medical College HospitalUkendtPrimiparous kvinder med singleton baby ved terminKina
-
Eastern Mediterranean UniversityAfsluttetFremadrettet hovedstilling | Scapular dyskinesis | Sagittal cervikal misdannelse | Afrundet skulderCypern
-
Finger ReliefAfsluttetKarpaltunnelsyndromForenede Stater
-
University of Maryland, BaltimoreIkke rekrutterer endnuKritisk sygdom | Sarkopeni | ICU erhvervet svaghedForenede Stater
-
Oregon Health and Science UniversityAfsluttet
-
University of Maryland, BaltimoreAktiv, ikke rekrutterendeKritisk sygdom | Muskelsvaghed | SarkopeniForenede Stater
-
Wolfgang Fitz, M.D.CyMedica Orthopedics, IncAfsluttetTotal knæarthroplastikForenede Stater