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

NCT ID: NCT03124914

Last Updated: 2018-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-19
• Study Completion Date: 2018-06-12

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.

Conditions

HIV Seropositivity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Patients considered physically active

Measures of strength and determination of neuromuscular fatigue

Group Type: ACTIVE_COMPARATOR

Neuromuscular tests

Intervention Type: OTHER

Neuromuscular tests

Patients considered physically inactive

Measures of strength and determination of neuromuscular fatigue

Group Type: ACTIVE_COMPARATOR

Neuromuscular tests

Intervention Type: OTHER

Neuromuscular tests

Interventions

Neuromuscular tests

Neuromuscular tests

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Nice

Nice, , France

Countries

France

Other Identifiers

16-PP-05

Identifier Type: -

Identifier Source: org_study_id