Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Questionnaires - Beck Depression Inventory Score
研究概览
简要总结
This study monitor the immediate and persistent impact of a preventive complex six-month program specifically developed for newly diagnosed people with multiple sclerosis on fatigue, mental and physical fitness, and quality of life. The study determined whether changes in clinical function are related to changes in neurohormones, and whether the effect of therapy is dependent on the active approach of study participants.
详细描述
The patients who were newly diagnosed with MS underwent a six-month preventive comprehensive program, which included individual physiotherapy focused on the treatment of functional disorders of the loco-motor system and therapy on a neurophysiological basis, group psychotherapy and controlled aerobic training. The participants were examined three times - before the start of the physiotherapy program, immediately after its completion and six months apart. Influence on physical fitness (spiroergometric examination), fatigue (Modify Fatigue Impact Scale, fatigue scale for motor and cognitive functions), depression (Beck scale for evaluation of depression), admission of disease RS (Inventory of admission of multiple sclerosis, quality of life) life and selected neurohormones (dehydroepiandrosterone-DHEA, dehydroepiandrosterone sulphate - DHEAS, cortisol).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •definite MS
- •stable clinical status in the preceding 3 months
- •imumnomodulatory treatment for at least two years (including glatiramer acetate, interferon beta-1a, 1b, mitoxantrone, fingolimod, natalizumab)
- •Expanded Disability Status Scale (EDSS)≤6
- •predominant motor impartment
- •six months or more without any physiotherapy
- •ability to undergo ambulatory physiotherapy
排除标准
- •other neurological disease or conditions disabling movement
研究组 & 干预措施
Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis
Providing information about the possibilities of physiotherapy, Computer Kinesiology, psychotherapy, Motor progam activating therapy, aerobic exercise
干预措施: Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis (Behavioral)
结局指标
主要结局
Questionnaires - Beck Depression Inventory Score
时间窗: change after six months of the program and after next six moths without therapy is being assessed
questionnaire is divided into thirteen categories and patients select a statement in each category which best fits their current feelings on the scale ranged from 0 (the best feelings) to 3 (the worst feelings). The maximum value of the total scale is 39 and shows the worst feeling of the person.
Questionnaires - The Satisfaction With Life Scale
时间窗: change after six months of the program and after next six moths without therapy is being assessed
The scale measures the current level of satisfaction with one's own life. Investigators express the extent to which they agree or disagree with the five statements. The rating scale contains 7 points (1- "strongly disagree" and 7 - "strongly agree"). The maximum number of points on the scale is 35 (maximum satisfaction with your life) and the minimum number of points is 5 (dissatisfaction with your life).
Questionnaires - Multiple Sclerosis Acceptance Questionnaire
时间窗: change after six months of the program and after next six moths without therapy is being assessed
This questionnaire consists of 20 statements that relate to the lives of patients with MS. The rating scale has seven points (1- "never pays" to 7 - "always pays"). The minimum value is 20 (minimum adaptation to the diagnosis of MS for a large limitation of the normal life of MS) and the maximum value is 140 points (maximum adaptation to the diagnosis of MS - without the limitation of the normal life of MS) .
Questionnaires - The Fatigue scale for motor and cognitive functions
时间窗: change after six months of the program and after next six moths without therapy is being assessed
FSMC - is an assessment of MS-related cognitive and motor fatigue. A Likert-type 5-point scale (ranging from 'does not apply at all' to 'applies completely') produces a score between 1 and 5 for each scored question. Thus minimum value is 20 (no fatigue at all) and maximum value is 100 (severest grade of fatigue).
次要结局
- Maximal oxygen uptake(change after six months of the program and after next six moths without therapy is being assessed)
- Ventilation capacity(change after six months of the program and after next six moths without therapy is being assessed)
- Metabolic utilization(change after six months of the program and after next six moths without therapy is being assessed)
- Cortisol(change after six months of the program and after next six moths without therapy is being assessed)
- Cortizone(change after six months of the program and after next six moths without therapy is being assessed)
- Dehydroepiandrosterone (DHEA)(change after six months of the program and after next six moths without therapy is being assessed)
- Relative ventilation(change after six months of the program and after next six moths without therapy is being assessed)
- 7β-hydroxydehydroepiandrosterone (7β-OH-DHEA )(change after six months of the program and after next six moths without therapy is being assessed)
- 7-oxo dehydroepiandrosterone (7-oxo-DHEA )(change after six months of the program and after next six moths without therapy is being assessed)
- Maximal oxygen pulse(change after six months of the program and after next six moths without therapy is being assessed)
研究者
Kamila Řasová
associate professor PhDr. Kamila Řasová, Ph.D.
Charles University, Czech Republic