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NCT06603727

Computerized Cognitive Rehabilitation of Patients With Cognitive Deficits Due to the Human Immunodeficiency Virus

Sponsor: Centre Hospitalier Universitaire Vaudois

View on ClinicalTrials.gov

Summary

WHO: 24 participants with cognitive deficits due to a Human Immunodeficiency Virus (HIV) infection, able to engage in moderate physical activity. WHY: The Human Immunodeficiency Virus is known to cause deficits in cognitive function, even under effective pharmacological viral load suppression. Cognitive dysfunction in patients with HIV is frequent and has a detrimental impact on their everyday personal and professional life. The purpose of this study is to evaluate two sets of computerized exercises combining cognitive and physical effort to see if they can improve executive function in patients with an HIV infection. WHAT: Study participants first undergo cognitive and physical assessments. Additional questionnaires will assess mood, everyday life cognition, function and quality. This will be followed by a 6 week training period with 2 training sessions a week. The effect of the physical and cognitive training will be measured in a post-training evaluation session. Six months after completion of the training, the study will evaluate cognitive and physical abilities of participants to study long-term effects of the respective training program. WHERE: Both the evaluation and the training sessions will be conducted on the premises of the Lausanne University Hospital (Rue du Bugnon 46, 1005 Lausanne, Switzerland)

Official title: Combined Cognitive and Physical Training for the Neurorehabilitation of Patients With Cognitive Deficits Due to the Human Immunodeficiency Virus: a Pilot Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-10-01

Completion Date

2026-08-31

Last Updated

2024-09-19

Healthy Volunteers

Conditions

Human Immunodeficiency Virus Cognitive Dysfunction

Interventions

DEVICE

Computerized Gaming Rehabilitation Program 1

Brain training games displayed on a large screen paired with physical exercise component. The program involves movements such as reaching, stepping, or stretching in place.

DEVICE

Computerized Gaming Rehabilitation Program 2

Brain training games displayed on a tablet device paired with physical exercise component. The program involves movements such as reaching, stepping, or stretching.

Inclusion Criteria: * Age ≥ 18 years * Diagnosis of an HIV infection * Undetectable HIV load in the serum (\<50 copies/mL) over the last 6 months prior to study inclusion. * Z-score ≤ -1.0 in at least one of the three following tests: * Color Trail Test (CTT) Flexibility Index * subtest Code of the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) * subtest Digit Span of the WAIS-IV * Z-score ≤ -1.0 in at least one of the following tests: * Symbol Digits Modalities Test (SDMT) * Brief Visuospatial Memory Test Revised (BVMT-R) * CTT Flexibility Index * Stroop Color-Word interference test Exclusion Criteria: * Clinically defined cause for cognitive deficits other than HIV * Diagnosis of severe depression according to a cut-off score of ≥ 27 of the Center for epidemiological studies - depression questionnaire (CES-D; Metral et al., 2020; Radloff, 1977) * Diagnosis of HIV-associated dementia according to the Frascati Critera (Antinori et al., 2007) * Current psychotic symptoms according to the Mini-International Neuropsychiatric Interview (M.I.N.I. - L, Sheehan et al., 1998) subscale of psychotic symptoms * Antidepressive, anxiolytic or cART medication that has been changed over the last month * Thoracic pain and/or heart palpitations at rest, during or following a physical effort (based on self-report) * For patients without known and clinically stable cardio-vascular disease: abnormal rest electrocardiogram readings suggestive of second degree type Mobitz or third degree atrioventricular blocking, pathological repolarization (T-wave inversion, ST elevation, abnormal QT lengthening in at least two corresponding leads), or typical features of channelopathies * Premature termination of maximal effort test due to cardiac problems * Falls in the past 12 weeks as evaluated in the enrolment interview (Hopkins Falls Grading Scale, Grade \>1) * High risk of falling according a cutoff score \> 15 sec in the Four Square Step Test (Dite \& Temple, 2002) * Incapacity to discriminate colors or insufficient visual acuity that cannot be corrected * Incapacity or unwillingness to provide informed consent * Insufficient knowledge of French to understand and follow instructions

Locations (1)

Lausanne University Hospital (CHUV)

Lausanne, Canton of Vaud, Switzerland