Combined Cognitive and Physical Training for the Neurorehabilitation of Patients With Cognitive Deficits Due to the Human Immunodeficiency Virus: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change in subjective everyday life cognition after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Masking will affect participants and study personnel, with exception to the personnel supervising the training programs.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in subjective everyday life cognition after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- Change in sustained attention after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)(6 weeks)
- Change in cognitive interference after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)(6 weeks)
- Change in design fluency after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)(6 weeks)
- Change in cognitive flexibility after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)(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)(6 weeks)
- Change in divided attention after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)(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)(6 weeks)
- Change in risk of falls after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)(6 weeks)
- Change in limits of postural stability after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)(6 weeks)
- Change in dynamic stability after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)(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)(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)(6 weeks)
- Change in heart rate variability after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)(6 weeks)
- Change in anxiety after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)(6 weeks)
- Change in mood after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)(6 weeks)
- Change in everyday life activity / quality of life after a 6 weeks period of gamified cognitive and physical training(6 weeks)
- Change in everyday life cognition after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)(6 weeks)
- Change in fatigue after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)(6 weeks)
- Change in apathy after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)(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)(6 weeks)
- Development of medication intake over the course of study participation.(6 weeks)
- Development of professional occupation/employment rate over the course of study participation.(6 weeks)
- Development of self-reported activity profile over the course of study participation.(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)(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)(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)(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)(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)(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)(6 weeks)
- Change in VO2 at anaerobic threshold after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)(6 weeks)
研究者
Prof. Arseny Sokolov, MD, PhD
Professor, MD
Centre Hospitalier Universitaire Vaudois