Targeting Subclinical Motor and Cognitive Impairment in Patients With Early Onset Multiple Sclerosis at High Risk of disEase Acitivity Through a Preventive personaLised and InnovAtive rehaBiLitation stratEgy. (RELIABLE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Symbol Digit Modalities Test (SDMT)
研究概览
简要总结
Our project proposal is based on an individualized rehabilitation approach in patients with early stage relapsing remission (RR) MS. This approach will be based on risk stratification obtained using several clinical and demographic parameters that are not commonly used in clinical practice. This risk score will be obtained from an extensive neuropsychological, psychosocial and physical assessment to which patients will undergo at baseline and at one-year follow-up.The risk score will allow a better stratification of patients' risk of disease worsening/progression and the application of a preventive and personalized strategy.
详细描述
This is a multicentric no-profit pilot study, composed by two phases. The objective of the first phase is to create a multi-factorial assessment and prognostic profiling into different risk categories, integrating different techniques in a common evaluation approach. MS patients, referred to the MS Centers of Careggi University Hospital and the Sheba Medical Centre in Tel-Aviv, will be recruit and assess at baseline and 12-months follow-up using a comprehensive approach. The patients will undergo an advanced motor performance evaluation, neuropsychological assessment, and a brain MRI scan to evaluate the presence of new/enlarging T2 lesions, new gadolinium-positive lesions, and volumetric analyses (e.g., total brain volume, grey matter volume, white matter volume, T2 lesions volume, normalized thalamic and hippocampal volume). Data collected from the comprehensive baseline and 12 months assessment will be used to generate a risk score for disease worsening in the short-term, classifying the patients into low/mild, moderate, or high risk. All the variables significantly associated with disease activity will be combined in the risk score.The objectives of II Phase are to apply the previously obtained risk score on a novel cohort using the same inclusion/exclusion criteria; to evaluate the impact of a combined rehabilitation approach in reducing the proportion of patients with disease activity.The risk score obtained from follow-up data of the test cohort applied to the newly recruited patients. Only patients with moderate to high risk of worsening in this new cohort will be included in the rehabilitation program. The included patients will receive an innovative and personalized rehabilitation approach, including counselling on lifestyle habits, an aerobic moderate to high-intensity physical training and a computerized cognitive rehabilitation program.The efficacy of the rehabilitation approach will be then evaluated by comparing patients included in this cohort with patients in the same risk groups included in the phase 1 cohort. Across Phases of the study, Uppsala University partner, will conduct a surveillance and will consider Social and ethical aspects of the integrated rehabilitation approach. Personalized preventive interventions and tailored risk information may raise pressing ethical issues that need careful reflection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •diagnosis of RRMS based on the 2017 McDonald criteria;
- •age ≥ 18 years;
- •EDSS ≤ 2.0;
- •disease duration ≤ 5 years;
- •verification of MS subtype,
- •duration of disease and EDSS will be accomplished by obtaining a signed consent form for the release of medical information from the treating neurologist.
排除标准
- •history of relevant psychiatric comorbidities.
- •Severely depressed subjects assessed through the Beck Depression Inventory (scores ≥ 29);
- •relapses or corticosteroid treatment in the 30 days before inclusion;
- •history of substance abuse;
- •presence of non-MS related physical or cognitive impairment that could make the patient unable to complete the study assessments.
研究组 & 干预措施
personalized combined physical and cognitive intervention
The exercise intervention will be aerobic and performed on a stationary bicycle and will comply with the basic principle of progressive overload, combined with a computer based cognitive rehabilitation program carried out twice a week for 12 weeks, using the Rehacom software.
干预措施: personalized combined physical and cognitive intervention (Other)
结局指标
主要结局
Symbol Digit Modalities Test (SDMT)
时间窗: baseline and 1 year followup cohort 1; baseline, 3 months and 1 year followup cohort 2
The SDMT is a simple matching task that requires the participant to refer to a reference key, in order to correctly match a geometric symbol with the corresponding number. Participant will be under a 90 second time constraint to quickly and correctly match each pair.
California Verbal Learning Test second edition (CVLT-II)
时间窗: baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
The CVLT test begins with the examiner reading a list of 16 words, participants are then instructed to report as many of the words as they can remember. After recall is recorded, the entire list is read again, altogether, there are five learning trials.
Stroop test
时间窗: baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
the reading time of the stimuli in the interference condition is assessed: there are colours written but the colour of the ink is different from the written word, the subject has to say the colour of the ink in which the word is written
Test Intelligenza Breve (TIB)
时间窗: baseline cohort 1 and baseline cohort 2
evaluation of the IQ estimation, the subject reads words with regular and irregular accents and takes the number of errors of words with irregular accents
9 hole peg test (9HPT)
时间窗: baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
to measure finger dexterity, the subject must take the pegs one at a time with the dominant hand and then with the other hand and insert them as quickly as possible into the holes and remove them
The Modified Fatigue Impact Scale (MFIS)
时间窗: baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
to measure fatigue
The Multiple Sclerosis Walking Scale (MSWS-12)
时间窗: baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
evaluate the participants subjective impact of walking.
Brief Visuo-Spatial Memory Test- Revised (BVMT-R)
时间窗: baseline and 1 year followup cohort 1; baseline, 3 months and 1year followup cohort 2
Participants are presented with six abstract designs for 10 seconds, the display is then removed from view and participant are instructed to draw the designs from memory via pencil on paper. Each design is scored from 0 to 2 points representing accuracy and location. There are three learning trials.
Word list generation (WLG)
时间窗: baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
the subject has to say as many words from the fruit and vegetable categories as they can think of in one and a half minutes
The Hospital Anxiety and Depression Scale (HADS)
时间窗: baseline and 1year followup cohort 1; baseline, 3 months and 1 year followup cohort 2
to measure anxiety and depression
Beck Depression Inventory second edition
时间窗: baseline and 1year followup cohort 1; baseline, end 3 months and 1year followup cohort 2
to measure depression
Multiple Sclerosis Quality of Life-54 (MSQOL-54)
时间窗: baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
to evaluate quality of life
handgrip test
时间窗: baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
a strength evaluation test
cognitive-motor interference
时间窗: baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
impact of a simple cognitive test - verbal fluency on a randomly extracted letter - on motor performances
Multiple Sclerosis Impact Scale (MSIS-29-V2)
时间窗: baseline and 1yearfollowup cohort 1; baseline, 3 months and 1year followup cohort 2
to evaluate the participants impact of Multiple Sclerosis.
six minutes walking test (6MWT)
时间窗: baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
to measure the distance a subject can travel by walking as fast as possible on a flat surface in six minutes.
Romberg test
时间窗: baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
to assess balance
Timed 25-foot walk
时间窗: baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
is a quantitative mobility and leg function performance test based on a timed 25-walk.
brain MRI scan
时间窗: baseline and 1 year followup cohort 1 and 2
to evaluate the presence of new/enlarging T2 lesions, new gadolinium-positive lesions, and volumetric analyses
International Physical Activity Questionnaire (IPAQ)
时间窗: baseline and 1 year followup cohort 1 and 2
to assess the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting.
次要结局
未报告次要终点