Human Immunodeficiency VirusNCT06603727
Computerized Cognitive Rehabilitation of Patients With Cognitive Deficits Due to the Human Immunodeficiency Virus
A study testing Computerized Gaming Rehabilitation Program 1 and Computerized Gaming Rehabilitation Program 2 in people with Human Immunodeficiency Virus and Cognitive Dysfunction, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus, Cognitive Dysfunction
- What is being tested?
- Computerized Gaming Rehabilitation Program 1 and Computerized Gaming Rehabilitation Program 2
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2024to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 12Show fewer
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Lausanne University Hospital (CHUV)
Lausanne, Canton of Vaud, 1011
About this study
Official title: Combined Cognitive and Physical Training for the Neurorehabilitation of Patients With Cognitive Deficits Due to the Human Immunodeficiency Virus: a Pilot Study
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.
Read more
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)
Read the detailed description
This is an exploratory Randomized Controlled Trial with the purpose of evaluating the potential of two sets of gamified cognitive and physical exercises in the neurorehabilitation of cognitive deficits due to an infection with the Human Immunodeficiency Virus (HIV).
Upon recruitment, eligible study participants (see 'Eligibility Criteria') receive a detailed oral and written description about the scientific background, aims and methods of the study. Additional information will be provided about potential benefits and risks associated with study participation, as well as about the voluntary nature of participation throughout the study. The participant's written informed consent is required for study enrollment.
After inclusion in the study, participants are randomized into one of two different training programs with equal chance of attribution and without possibility of choosing:
- Program 1 involves brain training and guided, light physical exercise games on a tablet device. The exercise involves movements such as reaching, stepping, and stretching. Warm-up and cool down sessions are mandated prior to and following the tasks.
- Program 2 involves gamified exercises displayed on a large screen. Participants use whole-body movements to complete the tasks. Tasks involve movements such as reaching, stepping, and jogging in place. These movements are tracked by a motion sensor. Warm-up and cool down sessions are mandated prior to and following the training sessions.
Independently of program attribution, participants engage in a pre-training assessment, a six-week training period, a post-training assessment and a 6-month-follow-up assessment.
Before the start of the training, participants are required to perform several cognitive and physical tests (including cyclo-ergospirometry) and fill out a number of questionnaires on subjective cognitive function, mood and quality of life. Additionally, an electroencephalography (EEG) will be performed to measure brain activity. The exercises, the questionnaires and the EEG serve as a baseline evaluation of cognitive, physical and neurophysiological function.
Following the first assessment, study participants engage in a six-week training period. In both programs, participants engage in two weekly trainings of ninety minutes duration each.
After completion of the training period, study participants engage in a post-training assessment to evaluate the effect of training on cognitive and physical performance. This session incorporates the same tasks and questionnaires as in the pre-training visit. An EEG will be used to characterize the training effects on dynamics of the underlying large-scale neuronal networks. The aim of the post-training assessment is to demonstrate immediate training effect of the two programs.
A final follow-up visit is scheduled 6 months after the completion of the last training session. The cognitive and physical testing together with the questionnaires and the EEG will be repeated to examine the long-term effects of the training programs.
- Being tested
- Computerized Gaming Rehabilitation Program 1, Computerized Gaming Rehabilitation Program 2
- Keywords
- HIV Infections, Communicable Diseases, Neurological Rehabilitation, Cognitive Behavioural Therapy, Exercise Therapy, Nervous System Diseases, Neurocognitive Disorders, Cognition Disorders, Mental Disorders
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Cognitive Dysfunction, HIV Infections, Communicable Diseases, Nervous System Diseases, Neurocognitive Disorders, Cognition Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Gaming Rehabilitation Program 1Device
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.
Computerized Gaming Rehabilitation Program 2Device
Brain training games displayed on a tablet device paired with physical exercise component. The program involves movements such as reaching, stepping, or stretching.
| Study group | Role | What they receive |
|---|---|---|
| Program 1 | Experimental | Computerized Gaming Rehabilitation Program 1 Receives: Device: Computerized Gaming Rehabilitation Program 1 |
| Program 2 | Active comparator | Computerized Gaming Rehabilitation Program 2 Receives: Device: Computerized Gaming Rehabilitation Program 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in subjective everyday life cognition after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Subjective executive function is measured by the Working Memory Questionnaire (WMQ), a 30-item, self-administered scale (score range from 0 to 120), addressing working memory (10 items), attention (10 items) and general executive function (10 items). The higher the score, the more it reflects cognitive difficulties.
Measured: 6 weeks
Change in speed of information processing after a 6 weeks period of gamified cognitive and physical training
Measured by the Symbol Digit Modalities Test (SDMT), scored from 0 to 110. The lower the score, the more it reflects cognitive difficulties.
Measured: 6 weeks
Change in cognitive flexibility after a 6 weeks period of cognitive and physical training (program 1 vs program 2)
Measured by the time completion of the Color Trails Test (CTT) in CTT1 and CTT2 (i.e., Flexibility Index: (CTT2-CTT1)/CTT1). The higher the Flexibility Index, the more it reflects cognitive difficulties.
Measured: 6 weeks
Change in visuospatial short-term memory after a 6 weeks period of cognitive and physical training (program 1 vs program 2)
Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R), scored from 0 to 36. The lower the score, the more it reflects cognitive difficulties.
Measured: 6 weeks
Secondary outcomes (30)
Change in sustained attention after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Measured with the Test of Variables of Attention (TOVA) using the reaction time (RT) and the false alarm rate (FA). The higher the RT and FA, the more they reflect cognitive difficulties.
Measured: 6 weeks
Change in cognitive interference after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Measured with the Denis-Kaplan Color-Word interference Stroop test using the time completion in each condition. The higher the time completion, the more it reflects cognitive difficulties.
Measured: 6 weeks
Change in design fluency after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
The Five-Point Test will be used to assess design fluency using the total number of design produced. The lower the score, the more it reflects cognitive difficulties.
Measured: 6 weeks
Change in cognitive flexibility after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
A subtest of a custom-made tablet-based cognitive evaluation tool will measure cognitive flexibility.
Measured: 6 weeks
Change in visuo-spatial and verbal working memory control after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Measured using the Digit and Visuo-Spatial Span Test
Measured: 6 weeks
Change in divided attention after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Measured using the Test of Attentional Performance subtest Divided Attention
Measured: 6 weeks
Change in body composition (body fat and muscle mass) after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Body composition will be measured by bioelectrical impedance measure using the percentage of body fat and muscle mass.
Measured: 6 weeks
Change in risk of falls after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Risk of falls will be assessed using the BTrackS Balance Plate (FDA registered class 1 medical device #3010668481).
Measured: 6 weeks
Change in limits of postural stability after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Limits of postural will be assessed using the BTrackS Balance Plate (FDA registered class 1 medical device #3010668481).
Measured: 6 weeks
Change in dynamic stability after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Dynamic stability will be assessed by the Four Square Step Test, which tests the participant's ability to step over objects forwards, sideways and backwards; the movements of the FSST are comparable to the ones implemented in the training program. The score is based on time taken to complete the test. The higher the score, the more it reflects balance difficulties.
Measured: 6 weeks
Change in ability to perform a cognitive and physical dual task after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
In order to assess cognitive and motor dual task ability, the study participant will perform the Timed Up and Go Cognitive. The score is based on time taken to complete the test and errors or hesitations. The higher the score, the more it reflects cognitive difficulties.
Measured: 6 weeks
Change in heart rate variability after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Heart rate and heart rate variability will be recorded at rest in supine position during a 5-minute window using a medical electrocardiogramm (ECG).
Measured: 6 weeks
Change in systolic and diastolic blood pressure after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Determined by the mean of three blood pressure measurements using a sphygmomanometer and a stethoscope.
Measured: 6 weeks
Change in anxiety after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI; 20 items) in French, scored from 20 to 80. The higher the score, the higher the level of anxiety.
Measured: 6 weeks
Change in mood after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Mood will be assessed using the Center for Epidemiologic Studies - Depression (CES-D; 20 items) in French, scored from 0 to 60. The higher the score, the higher the level of depression.
Measured: 6 weeks
Change in everyday life activity / quality of life after a 6 weeks period of gamified cognitive and physical training
Specifically developped for patients with an HIV infection, the Medical Outcomes Study HIV Health Survey (MOS-HIV; 35 items) will be used to assess everyday life activities and health-related quality of life. The score ranges from 0 to 100. The lower the score, the poorer the quality of life.
Measured: 6 weeks
Change in everyday life cognition after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Everyday life cognition will be assessed using the Cognitive Failure Questionnaire (CFQ; 32 items). The score ranges from 0 to 128. The higher the score, the more it reflects cognitive difficulties.
Measured: 6 weeks
Change in fatigue after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Study participants will rate their degree of physical, cognitive and psychosocial fatigue on the Modified Fatigue Impact Scale (MFIS; 21 items). The score ranges from 0 to 84. The higher the score, the greater the level of fatigue.
Measured: 6 weeks
Change in apathy after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Using the self-administred Dimensional Apathy Scale (DAS; 24 items), study participants will rate their degree of apathy. The score ranges from 0 to 96. The higher the score, the greater the level of apathy.
Measured: 6 weeks
Change in alcohol and other substance consumption after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
The habits in the consumption of alcohol and other substances will be evaluated with an adapted version of the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST; 8 items; Khan et al, 2011).
Measured: 6 weeks
Development of medication intake over the course of study participation.
Participants' medication intake over the course of the study will be recorded in the register of an ongoing prospective, longitudinal and multicenter study, called the Neurocognitive Assessment in the Metabolic and Aging Cohort study (NAMACO).
Measured: 6 weeks
Development of professional occupation/employment rate over the course of study participation.
Participants' professional occupation/employment rate over the course of the study will be recorded in the register of an ongoing prospective, longitudinal and multicenter study, called the Neurocognitive Assessment in the Metabolic and Aging Cohort study (NAMACO). The employment rate will be measured in full-time equivalent, ranging from 0 to 100 %. The higher the employment rate, the better.
Measured: 6 weeks
Development of self-reported activity profile over the course of study participation.
Participants' self-reported activity profile over the course of the study will be recorded in the register of an ongoing prospective, longitudinal and multicenter study, called the Neurocognitive Assessment in the Metabolic and Aging Cohort study (NAMACO).
Measured: 6 weeks
Change in the theta power frequency band over the frontal brain region (Anguera et al., 2022) after a 6-week period of gamified cognitive and physical training (program 1 vs program 2)
Measured with an electroencephalogram (EEG) during the Test of Variable of Attention (TOVA).
Measured: 6 weeks
Change in the latency of the P3b (Event-Related Potential; Anguera et al., 2013) after a 6-week period of gamified cognitive and physical training (program 1 vs program 2)
Measured with an electroencephalogram (EEG) during the TOVA.
Measured: 6 weeks
Change in the temporal dynamic of the resting brain activity (microstates analysis; Michel and Koenig, 2018; Spring et al, 2017) after a 6-week period of gamified cognitive and physical training (program 1 vs program 2)
Measured with an electroencephalogram (EEG) during the resting state
Measured: 6 weeks
Change in forced expiratory volume in one second (FEV1) after a 6-week period of gamified cognitive and physical training (program 1 vs program 2)
Measured by a forced exhalation in the first second of a breath into a spirometer.
Measured: 6 weeks
Change in maximal pulmonary capacity (measured in liters) after a 6-week period of gamified cognitive and physical training (program 1 vs program 2)
Measured by a forced exhalation into a spirometer.
Measured: 6 weeks
Change in peak oxygen capacity (VO2 peak) after a 6-week period of gamified cognitive and physical training (program 1 vs program 2)
Measure using a standardized maximal effort test with incremental exercise on a cycling ergometer with gas exchange analyses.
Measured: 6 weeks
Change in VO2 at anaerobic threshold after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
VO2 at anaerobic threshold will be determined using a cyclo-ergospirometry.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Arseny Sokolov, MD, PhD, Centre Hospitalier Universitaire Vaudois
- Investigators
- Arseny A. Sokolov, Prof MD PhD, Principal investigator, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, SwitzerlandEtienne Sallard, PhD, Study chair, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603727
- Sponsor's protocol ID
- CHUV-DNC-CCT-HIV-2022
- Status last verified
- Sep 2024
- First submitted
- 12 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smith, A. (1982). Symbol digit modalities test (SDMT) manual (revised) Western psychological services. Los Angeles.
Delis DC, Kramer JH, Kaplan E, Holdnack J. Reliability and validity of the Delis-Kaplan Executive Function System: an update. J Int Neuropsychol Soc. 2004 Mar;10(2):301-3. doi: 10.1017/S1355617704102191. No abstract available.
PubMed 15012851Benedict, R. H. (1997). Brief Visuospatial Memory Test-Revised (BVMT-R). Odessa, FL: Psychological Assessment Resources. In: Inc
Vallat-Azouvi C, Pradat-Diehl P, Azouvi P. The Working Memory Questionnaire: a scale to assess everyday life problems related to deficits of working memory in brain injured patients. Neuropsychol Rehabil. 2012;22(4):634-49. doi: 10.1080/09602011.2012.681110. Epub 2012 Apr 27.
PubMed 22537095Brandt, J. (1991). The hopkins verbal learning test: Development of a new memory test with six equivalent forms. Clinical Neuropsychologist, 5(2), 125-142.
Rieu D, Bachoud-Levi AC, Laurent A, Jurion E, Dalla Barba G. [French adaptation of the Hopkins Verbal Learning Test]. Rev Neurol (Paris). 2006 Jun;162(6-7):721-8. doi: 10.1016/s0035-3787(06)75069-x. French.
PubMed 16840980Greenberg, L., Kindschi, C., & Corman, C. (1996). TOVA clinical guide. Los Alamitos, CA: Universal Attention Disorders.
Kollins SH, DeLoss DJ, Canadas E, Lutz J, Findling RL, Keefe RSE, Epstein JN, Cutler AJ, Faraone SV. A novel digital intervention for actively reducing severity of paediatric ADHD (STARS-ADHD): a randomised controlled trial. Lancet Digit Health. 2020 Apr;2(4):e168-e178. doi: 10.1016/S2589-7500(20)30017-0. Epub 2020 Feb 24.
PubMed 33334505Regard M, Strauss E, Knapp P. Children's production on verbal and non-verbal fluency tasks. Percept Mot Skills. 1982 Dec;55(3 Pt 1):839-44. doi: 10.2466/pms.1982.55.3.839. No abstract available.
PubMed 7162920Michel CM, Koenig T. EEG microstates as a tool for studying the temporal dynamics of whole-brain neuronal networks: A review. Neuroimage. 2018 Oct 15;180(Pt B):577-593. doi: 10.1016/j.neuroimage.2017.11.062. Epub 2017 Dec 2.
PubMed 29196270Spring JN, Tomescu MI, Barral J. A single-bout of Endurance Exercise Modulates EEG Microstates Temporal Features. Brain Topogr. 2017 Jul;30(4):461-472. doi: 10.1007/s10548-017-0570-2. Epub 2017 May 20.
PubMed 28528447Levett DZH, Jack S, Swart M, Carlisle J, Wilson J, Snowden C, Riley M, Danjoux G, Ward SA, Older P, Grocott MPW; Perioperative Exercise Testing and Training Society (POETTS). Perioperative cardiopulmonary exercise testing (CPET): consensus clinical guidelines on indications, organization, conduct, and physiological interpretation. Br J Anaesth. 2018 Mar;120(3):484-500. doi: 10.1016/j.bja.2017.10.020. Epub 2017 Nov 24.
PubMed 29452805Dite W, Temple VA. A clinical test of stepping and change of direction to identify multiple falling older adults. Arch Phys Med Rehabil. 2002 Nov;83(11):1566-71. doi: 10.1053/apmr.2002.35469.
PubMed 12422327Shumway-Cook A, Brauer S, Woollacott M. Predicting the probability for falls in community-dwelling older adults using the Timed Up & Go Test. Phys Ther. 2000 Sep;80(9):896-903.
PubMed 10960937Radloff, L. S. (1977). The CES-D Scale:A Self-Report Depression Scale for Research in the General Population. Applied Psychological Measurement, 1(3), 385-401.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Cognitive and Physical Training for the Neurorehabilitation of Patients With Cognitive Deficits Due to the Human Immunodeficiency Virus: a Pilot Study
- ClinicalTrials.gov ID
- NCT06603727
- Acronym / sponsor ID
- CHUV-DNC-CCT-HIV-2022
- Keywords
- HIV Infections, Communicable Diseases, Neurological Rehabilitation, Cognitive Behavioural Therapy, Exercise Therapy, Nervous System Diseases, Neurocognitive Disorders, Cognition Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
This is an exploratory Randomized Controlled Trial with the purpose of evaluating the potential of two sets of gamified cognitive and physical exercises in the neurorehabilitation of cognitive deficits due to an infection with the Human Immunodeficiency Virus (HIV).
Upon recruitment, eligible study participants (see 'Eligibility Criteria') receive a detailed oral and written description about the scientific background, aims and methods of the study. Additional information will be provided about potential benefits and risks associated with study participation, as well as about the voluntary nature of participation throughout the study. The participant's written informed consent is required for study enrollment.
After inclusion in the study, participants are randomized into one of two different training programs with equal chance of attribution and without possibility of choosing:
- Program 1 involves brain training and guided, light physical exercise games on a tablet device. The exercise involves movements such as reaching, stepping, and stretching. Warm-up and cool down sessions are mandated prior to and following the tasks.
- Program 2 involves gamified exercises displayed on a large screen. Participants use whole-body movements to complete the tasks. Tasks involve movements such as reaching, stepping, and jogging in place. These movements are tracked by a motion sensor. Warm-up and cool down sessions are mandated prior to and following the training sessions.
Independently of program attribution, participants engage in a pre-training assessment, a six-week training period, a post-training assessment and a 6-month-follow-up assessment.
Before the start of the training, participants are required to perform several cognitive and physical tests (including cyclo-ergospirometry) and fill out a number of questionnaires on subjective cognitive function, mood and quality of life. Additionally, an electroencephalography (EEG) will be performed to measure brain activity. The exercises, the questionnaires and the EEG serve as a baseline evaluation of cognitive, physical and neurophysiological function.
Following the first assessment, study participants engage in a six-week training period. In both programs, participants engage in two weekly trainings of ninety minutes duration each.
After completion of the training period, study participants engage in a post-training assessment to evaluate the effect of training on cognitive and physical performance. This session incorporates the same tasks and questionnaires as in the pre-training visit. An EEG will be used to characterize the training effects on dynamics of the underlying large-scale neuronal networks. The aim of the post-training assessment is to demonstrate immediate training effect of the two programs.
A final follow-up visit is scheduled 6 months after the completion of the last training session. The cognitive and physical testing together with the questionnaires and the EEG will be repeated to examine the long-term effects of the training programs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Program 1 | Experimental | Device: Computerized Gaming Rehabilitation Program 1Computerized Gaming Rehabilitation Program 1 |
| Program 2 | Active comparator | Device: Computerized Gaming Rehabilitation Program 2Computerized Gaming Rehabilitation Program 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- Z-score ≤ -1.0 in at least one of the following tests:
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized Gaming Rehabilitation Program 1Brain 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 | Program 1 |
| Computerized Gaming Rehabilitation Program 2Brain training games displayed on a tablet device paired with physical exercise component. The program involves movements such as reaching, stepping, or stretching. | Device | Program 2 |
Primary outcome
Change in subjective everyday life cognition after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Subjective executive function is measured by the Working Memory Questionnaire (WMQ), a 30-item, self-administered scale (score range from 0 to 120), addressing working memory (10 items), attention (10 items) and general executive function (10 items). The higher the score, the more it reflects cognitive difficulties.
Change in speed of information processing after a 6 weeks period of gamified cognitive and physical training
Time frame: 6 weeks
Measured by the Symbol Digit Modalities Test (SDMT), scored from 0 to 110. The lower the score, the more it reflects cognitive difficulties.
Change in cognitive flexibility after a 6 weeks period of cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Measured by the time completion of the Color Trails Test (CTT) in CTT1 and CTT2 (i.e., Flexibility Index: (CTT2-CTT1)/CTT1). The higher the Flexibility Index, the more it reflects cognitive difficulties.
Change in visuospatial short-term memory after a 6 weeks period of cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R), scored from 0 to 36. The lower the score, the more it reflects cognitive difficulties.
30 secondary outcomes
Change in sustained attention after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Change in cognitive interference after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Change in design fluency after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Change in cognitive flexibility after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Change in visuo-spatial and verbal working memory control after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Change in divided attention after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Change in body composition (body fat and muscle mass) after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Change in risk of falls after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Change in limits of postural stability after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Change in dynamic stability after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Change in ability to perform a cognitive and physical dual task after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Change in heart rate variability after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Change in systolic and diastolic blood pressure after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Change in anxiety after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Change in mood after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Change in everyday life activity / quality of life after a 6 weeks period of gamified cognitive and physical training
Time frame: 6 weeks
Change in everyday life cognition after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Change in fatigue after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Change in apathy after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Change in alcohol and other substance consumption after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Development of medication intake over the course of study participation.
Time frame: 6 weeks
Development of professional occupation/employment rate over the course of study participation.
Time frame: 6 weeks
Development of self-reported activity profile over the course of study participation.
Time frame: 6 weeks
Change in the theta power frequency band over the frontal brain region (Anguera et al., 2022) after a 6-week period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Change in the latency of the P3b (Event-Related Potential; Anguera et al., 2013) after a 6-week period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Change in the temporal dynamic of the resting brain activity (microstates analysis; Michel and Koenig, 2018; Spring et al, 2017) after a 6-week period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Change in forced expiratory volume in one second (FEV1) after a 6-week period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Change in maximal pulmonary capacity (measured in liters) after a 6-week period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Change in peak oxygen capacity (VO2 peak) after a 6-week period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Change in VO2 at anaerobic threshold after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- BackgroundSmith, A. (1982). Symbol digit modalities test (SDMT) manual (revised) Western psychological services. Los Angeles.
- Background: PubMed 15012851Delis DC, Kramer JH, Kaplan E, Holdnack J. Reliability and validity of the Delis-Kaplan Executive Function System: an update. J Int Neuropsychol Soc. 2004 Mar;10(2):301-3. doi: 10.1017/S1355617704102191. No abstract available.
- BackgroundBenedict, R. H. (1997). Brief Visuospatial Memory Test-Revised (BVMT-R). Odessa, FL: Psychological Assessment Resources. In: Inc
- Background: PubMed 22537095Vallat-Azouvi C, Pradat-Diehl P, Azouvi P. The Working Memory Questionnaire: a scale to assess everyday life problems related to deficits of working memory in brain injured patients. Neuropsychol Rehabil. 2012;22(4):634-49. doi: 10.1080/09602011.2012.681110. Epub 2012 Apr 27.
- BackgroundBrandt, J. (1991). The hopkins verbal learning test: Development of a new memory test with six equivalent forms. Clinical Neuropsychologist, 5(2), 125-142.
- Background: PubMed 16840980Rieu D, Bachoud-Levi AC, Laurent A, Jurion E, Dalla Barba G. [French adaptation of the Hopkins Verbal Learning Test]. Rev Neurol (Paris). 2006 Jun;162(6-7):721-8. doi: 10.1016/s0035-3787(06)75069-x. French.
- BackgroundGreenberg, L., Kindschi, C., & Corman, C. (1996). TOVA clinical guide. Los Alamitos, CA: Universal Attention Disorders.
- Background: PubMed 33334505Kollins SH, DeLoss DJ, Canadas E, Lutz J, Findling RL, Keefe RSE, Epstein JN, Cutler AJ, Faraone SV. A novel digital intervention for actively reducing severity of paediatric ADHD (STARS-ADHD): a randomised controlled trial. Lancet Digit Health. 2020 Apr;2(4):e168-e178. doi: 10.1016/S2589-7500(20)30017-0. Epub 2020 Feb 24.
- Background: PubMed 7162920Regard M, Strauss E, Knapp P. Children's production on verbal and non-verbal fluency tasks. Percept Mot Skills. 1982 Dec;55(3 Pt 1):839-44. doi: 10.2466/pms.1982.55.3.839. No abstract available.
- Background: PubMed 29196270Michel CM, Koenig T. EEG microstates as a tool for studying the temporal dynamics of whole-brain neuronal networks: A review. Neuroimage. 2018 Oct 15;180(Pt B):577-593. doi: 10.1016/j.neuroimage.2017.11.062. Epub 2017 Dec 2.
- Background: PubMed 28528447Spring JN, Tomescu MI, Barral J. A single-bout of Endurance Exercise Modulates EEG Microstates Temporal Features. Brain Topogr. 2017 Jul;30(4):461-472. doi: 10.1007/s10548-017-0570-2. Epub 2017 May 20.
- Background: PubMed 29452805Levett DZH, Jack S, Swart M, Carlisle J, Wilson J, Snowden C, Riley M, Danjoux G, Ward SA, Older P, Grocott MPW; Perioperative Exercise Testing and Training Society (POETTS). Perioperative cardiopulmonary exercise testing (CPET): consensus clinical guidelines on indications, organization, conduct, and physiological interpretation. Br J Anaesth. 2018 Mar;120(3):484-500. doi: 10.1016/j.bja.2017.10.020. Epub 2017 Nov 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arseny A. Sokolov, Prof MD PhD principal investigator
Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland
Etienne Sallard, PhD study chair
Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Gaming Rehabilitation Program 1 and Computerized Gaming Rehabilitation Program 2 in people with Human Immunodeficiency Virus and Cognitive Dysfunction, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Etienne Sallard, PhD (+ 41 21 314 24 61, etienne.sallard@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in subjective everyday life cognition after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06603727, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.