Digital Rehabilitation With Cognitive Training, Physical Activity and Mindfulness for People With Post-acute COVID-19 Syndrome With Cognitive Impairment. REHABCOVID Project.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 172
- 试验地点
- 2
- 主要终点
- Differences between groups in scores of auditory attention
研究概览
简要总结
Although most infected people survive the infection, many have persistent sequelae or symptoms, which cause disability or decreased quality of life. The World Health Organization has called on countries to prioritize the rehabilitation of the consequences of COVID-19 in both the medium and long term, as this chronicity is expected to impact the health public and the economy in the coming years.
RehabCOVID (also referred to as RehabNautilus) is born from the need to provide solutions to persistent cognitive impairment symptoms of people who have suffered from COVID-19. Thus, we will offer people with long COVID that accomplish inclusion/exclusion criteria to participate in a randomized clinical trial to evaluate the effectiveness of cognitive stimulation therapy combined with physical exercise and mindfulness. The current project is a single-blind randomized control study, where we will compare two combined interventions with a control group that will encompass different functional, structural, and biochemical changes and interactions in the brain. We will study the effects that this combined intervention produces in the brain. We expect to gain more insight into the specific neuroplasticity mechanisms of cognitive persistent COVID symptoms.
详细描述
The current project is a single-blind randomized clinical study, where we will compare two combined interventions with a control group that will encompass different functional, structural, and biochemical changes and interactions in the brain. We will study the effects that this combined intervention produces in the brain. We expect to gain more insight into the specific neuroplasticity mechanisms of cognitive persistent COVID symptoms.
Specifically, we aim to:
- Examine the effects of a combined intervention in a population of long-COVID patients on various domains: cognition; emotion; physical health and quality of life.
- Study the molecular mechanisms (biomarkers of inflammation, vascular risk, growth factors, angiogenesis, neurogenesis, and cellular metabolism markers of neural plasticity) by which the combined interventions influence brain functions.
- Compare the levels of neural plasticity-related miRNAs and Sirt-1 protein in the plasma of long-COVID patients of the experimental groups versus the active control group.
- Examine specific plasticity effects of each of the two interventions regarding structural magnetic resonance imaging (MRI) combined with volumetry and morphometry, resting-state functional MRI.
- Determine the influence that demographic characteristics, previous pathologies, lifestyle, baseline brain state, and genetic polymorphisms can have on neuroplasticity.
We hypothesize that we will find recovery in our three groups, although it will be enhanced in the two experimental groups (those that combine cognitive training with physical activity and mindfulness) compared to our control group.
- Post-COVID patients of the experimental groups will perform better than those patients of the active control group in cognition (episodic memory tests, executive function, attention, and speed processing), functional capacity, mental health, and quality of life measures at the end of the intervention.
- Post-COVID patients of the experimental groups will show greater changes in biomarkers than those patients of the active control group at the end of the intervention. These changes will include higher levels of Sirt-1 and regulation of neural plasticity-related miRNAs in plasma from patients in the experimental group.
- We will find an association between changes in biomarkers and cognitive, functional capacity and mental health outcomes in individuals of the experimental groups.
- Post-COVID patients of the experimental groups will show greater improvements in grey and white matter structural data and functional connectivity than those patients of the active control group at the end of the intervention.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years old.
- •Participants with a diagnosis of COVID-19 presenting persistent neurological symptoms at least 12 weeks after acute infection.
- •They will have cognitive complaints
- •Consent from a physician to engage in an exercise intervention
排除标准
- •Established diagnosis before COVID-19 disease of psychiatric, neurological, developmental disorder, or systemic pathologies are known to cause cognitive deficits.
- •Motor or sensory alterations that impede the rehabilitation program.
结局指标
主要结局
Differences between groups in scores of auditory attention
时间窗: Before the intervention and 12 weeks later
Auditory attention is measured with Digit Span Forward from WAIS-IV. Participants are asked to repeat numbers in the same order as read aloud by the examiner. Higher scores mean a better outcome.
Differences between groups in scores of phonetic fluency
时间窗: Before the intervention and 12 weeks later
Phonetic fluency is measured with the FAS test. It consists of saying words that start with a certain letter, as many words as possible must be mentioned during a specific time of 1 minute. The standard administration of the test provides three letters, the most used are the letters F, A, and S. Higher scores indicate better performance.
Differences between groups in scores of global cognition
时间窗: Before the intervention and 12 weeks later
Global cognition was assessed with the Montreal Cognitive Assessment (MoCA) a screening tool designed to identify mild cognitive impairment (MCI) and other cognitive deficits. The MoCA takes around 10-15 minutes to complete and consists of 30 items (range=0-30). Higher scores mean a better outcome.
Differences between groups in scores of working memory_DSB
时间窗: Before the intervention and 12 weeks later
Working memory is measured with Digit Span Backward from WAIS-IV. Participants are asked to repeat the numbers in the reverse order of that presented by the examiner. Higher scores mean a better outcome.
Differences between groups in scores of sustained attention and impulsivity
时间窗: Before the intervention and 12 weeks later
Conners Continuous Performance Test - 2nd edition (CPT-II) is task-oriented computerised assessment of attention-related problems. Participants are presented with a repetitive array of visual stimuli on a computer screen for 14 min. Participants are instructed to press the space bar every time a letter other than "X" appears and to not press the space bar when "X" appears. The rate of stimulus presentation varies according to 1, 2, and 4 s intervals throughout the task. Measures: Correct Detection (Higher rates indicate better outcome), Reaction times (Lower scores indicate better outcome), Omission errors (Lower rates indicate better outcome), and Commission errors (Lower rates indicate better outcome).
Differences between groups in scores of selective attention, inhibition, and processing speed
时间窗: Before the intervention and 12 weeks later
Selective attention, inhibition, and processing speed are measured with the Stroop Color and Word Test. Participants are asked to name the color of a series of color patches (Stroop Color Naming), read a series of color words (Stroop Word Reading), and name the color of a series of color words where the word and color do not match (e.g., the word "red" written in blue ink), Stroop Color-Word Interference. Higher scores mean a better outcome.
Differences between groups in scores of Visual scanning and processing speed
时间窗: Before the intervention and 12 weeks later
Visual scanning and processing speed are measured with the Trail-Making Test-A version. Participants are asked to connect a series of numbered circles on a page in numerical order. Higher scores mean a better outcome.
Differences between groups in scores of semantic verbal fluency
时间窗: Before the intervention and 12 weeks later
Semantic verbal fluency is measured with the ANIMAL test. It consists of generating the name of as many species of animals as possible within 1min. Higher scores indicate better performance.
Differences between groups in scores of Executive functioning and cognitive flexibility
时间窗: Before the intervention and 12 weeks later
Executive functioning and cognitive flexibility are measured with the Trail-Making Test-B version. Participants are asked to connect a series of circles that contain both numbers and letters in alternating numerical and alphabetical order. Higher scores mean a better outcome.
Differences between groups in scores of Perceptual Reasoning
时间窗: Before the intervention and 12 weeks later
Perceptual Reasoning is measured with Matrices from the WAIS-IV. Participants are presented with a pattern or design with one missing piece and are asked to select the correct piece from a set of options to complete the pattern. Higher scores on the Perceptual Reasoning Index mean a better outcome.
Differences between groups in scores of memory and everyday forgetfulness
时间窗: Before the intervention and 12 weeks later
Memory and everyday forgetfulness are measured with The Memory Failures of Everyday-MFE Questionnaire is a self-reported test that allows an assessment of memory and everyday forgetfulness. It is a unifactorial questionnaire and consists of 30 items. The total score results from the sum of the scores in each item, from 1 to 30. The MFE can assess the current situation of the patients and their evolution long-term or changes due to treatment. Scores \<8 represent an optimal memory function. Lower scores indicate better outcomes.
Differences between groups in scores of processing speed
时间窗: Before the intervention and 12 weeks later
The Digit Symbol Coding subtest from the WAIS-III is a neuropsychological assessment instrument for the detection of brain dysfunction in children and adults. It consists of replacing symbols that lack verbal meaning with numbers based on a key. Higher scores indicate better outcomes.
Differences between groups in scores of verbal memory and learning
时间窗: Before the intervention and 12 weeks later
Verbal memory and learning are measured with the Rey Auditory Verbal Learning Test (RAVLT). It is a word-learning test where five presentations of a 15-word list are given, each followed by an attempted recall. This is followed by a second 15-word interference list (list B), followed by a recall of list A. Delayed recall and recognition are also tested. Higher scores mean a better outcome.
次要结局
- Differences between groups in scores of anxiety(Before the intervention and 12 weeks later)
- Differences between groups in scores of depression(Before the intervention and 12 weeks later)
- Differences between groups in scores of Mindfulness levels(Before the intervention and 12 weeks later)
- Differences between groups in scores of Fatigue(Before the intervention and 12 weeks later)
- Differences between groups in scores of psychological flexibility(Before the intervention and 12 weeks later)
- Differences between groups in Functionality(Before the intervention and 12 weeks later)
- Differences between groups in scores of Sleep Quality(Before the intervention and 12 weeks later)
- Differences between groups in scores of Quality of Life(Before the intervention and 12 weeks later)
- Differences between groups in scores of performed physical activity(Before the intervention and 12 weeks later)
- Differences between groups in White Matter integrity(Before the intervention and 12 weeks later)
- Differences between groups in brain Volumetry(Before the intervention and 12 weeks later)
- Differences between groups in Resting-state connectivity(Before the intervention and 12 weeks later)
- Differences between groups in rate of expression analysis of Sirt-1 levels(Before the intervention and 12 weeks later)
- Differences between groups in rate of expression analysis of different microRNAs(Before the intervention and 12 weeks later)
研究者
Maite Garolera
Principal Investigator of the Brain, Cognition, and Behavior Research Group (C3-CST).
Consorci Sanitari de Terrassa