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

NCT03124914 | Completed

• 1 other identifier: 16-PP-05
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Seropositivity

Outcome Measures

Primary Outcomes (1)

• relationship between neuromuscular fatigue, perceived fatigue and the level of physical activity

  through study completion, 1 year after the start

Study Arms (2)

Patients considered physically active

ACTIVE COMPARATOR

Measures of strength and determination of neuromuscular fatigue

Other: Neuromuscular tests

Patients considered physically inactive

ACTIVE COMPARATOR

Measures of strength and determination of neuromuscular fatigue

Other: Neuromuscular tests

Interventions

Neuromuscular tests OTHER

Neuromuscular tests

Patients considered physically active; Patients considered physically inactive

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• HIV patient - PLHIV (person living with HIV)
• Patient aged between 40 and 60
• patient attended the Nice University Hospital

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, 06200, France

Location

MeSH Terms

Conditions

HIV Seropositivity

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2016
• First Posted: April 24, 2017
• Study Start: April 19, 2017
• Primary Completion: April 19, 2018
• Study Completion: June 12, 2018
• Last Updated: July 24, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)