Influence of Different Rehabilitative Aerobic Exercise Programs on (Anti-) Inflammatory Immune Signalling, Cognitive Performance and Processing Skills in Persons With MS - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Tregs
研究概览
简要总结
Regular physical activity is known to reduce the risk for some neurodegenerative disorders and their symptoms. Several studies have shown positive effects of therapeutic exercise interventions on motor- and cognitive function as well as psychosocial benefits in persons with multiple sclerosis (MS). To improve exercise recommendations, it is necessary to learn more about the underlying biological mechanisms. A reduction of inflammatory stress through physical exercise has been suspected as one key mechanism, mediating the positive effects of exercise in the context of MS (being a "classical" neuro-inflammatory disease). This randomized controlled trial aims to investigate the influence of two different rehabilitative endurance exercise programs (3x/week moderate vs. vigorous endurance exercise) on (1) (anti-)inflammatory immune signalling and (2) various aspects of participation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Definite diagnosis of MS (according to the revised McDonald criteria 2010)
- •Expanded Disability Status Scale 3.0 - 6.0
- •Age > 21
- •Relapsing remitting or secondary progressive MS
- •Informed Consent as documented by signature
排除标准
- •Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,
- •Define drugs not allowed during the study or for specific periods of time prior to the administration of the test dose,
- •Women who are pregnant or breast feeding,
- •Intention to become pregnant during the course of the study,
- •Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases.
- •Female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
- •Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),
- •Known or suspected non-compliance, drug or alcohol abuse,
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- •Participation in another study with investigational drug within the 30 days preceding and during the present study,
- •Previous enrolment into the current study,
- •Enrolment of the investigator, his/her family members, employees and other dependent persons
结局指标
主要结局
Tregs
时间窗: Three weeks (day 0 to day 21)
Proportion of regulatory T-cells with higher values indicating higher levels of Inflammation.
次要结局
- Soluble factors (cytokines, tryptophan metabolites, blood brain barrier markers)(Change from baseline (day 0) to directly after and 3-hours after the first exercise session (on day 0) and over 3-weeks (day 0 to day 21))
- Immune status(Three weeks (day 0 to day 21))
- Migratory Potential of peripheral mononuclear cells (PBMC)(Three weeks (day 0 to day 21))
- Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS)(Three weeks (day 0 to day 21))
- Endurance capacity(Three weeks (day 0 to day 21))
- Hospital Anxiety and Depression Scale (HADS)(Three weeks (day 0 to day 21)
- Patient-Reported Outcome Measurement Information System (PROMIS)(Three weeks (day 0 to day 21))
- Assessment of Motor and Processing Skills (AMPS)(Three weeks (day 0 to day 21))
- Test battery of attention (TAP)(Three weeks (day 0 to day 21))
- Fatigue Scale of Motor and cognitive function (FSMC)(Three weeks (day 0 to day 21))
研究者
Jens Bansi
Sport Scientist and therapist
Klinik Valens