Transient and Immediate Motor Effects of Exercise in Progressive Multiple Sclerosis: A Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Functional mobility
研究概览
简要总结
Endurance training is a cornerstone of rehabilitation in Multiple Sclerosis (MS) due to its beneficial effects on multiple MS-related symptoms, such as health-related quality of life, aerobic capacity (VO2peak), functional mobility, gait, depressive symptoms, and fatigue.
Persons with progressive phenotypes of MS, namely primary progressive MS (PPMS) and secondary progressive (SPMS), represent a minor proportion of the total MS population, thus having been underrepresented in previous studies. The generalizability of existing evidence may be compromised by differences in symptom expression between MS phenotypes, with a dominance of motor symptoms (i.e., paraspasticity and/or paraparesis) in PPMS and SPMS.
Adding up to this, clinical experiences of neurologists and sports scientists reveal that the effects of endurance exercise are characterized by a distinct time course, firstly inducing a minor and transient deterioration of motor symptoms that is followed by motor symptom alleviation beyond baseline level. This phenomenon was mainly related to the performance of High-Intensity Interval training (HIIT), but not to moderate-intensity continuous training (MCT).
Therefore, this pilot study aims to systematically investigate the time course of acute motor effects on spasticity, functional mobility, gait, and dexterity in persons with PPMS and SPMS following two different endurance training protocols, that are HIIT and MCT.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Blinding of the principal investigator and research assistant towards group allocation is ensured by a unique subject identification code given to each participant.
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
- •adult age (≥ 18 years)
- •definite MS diagnosis according the 2017 revised McDonald criteria
- •PPMS/SPMS phenotype according to the 2013 revised Lublin criteria
- •Expanded Disability Status Scale (EDSS) score ≤ 6.0
- •Informed Consent as documented by signature of participants and PI
排除标准
- •severe lower extremity spasticity or severe concomitant disease states (i.e., orthopaedic, cardiovascular, metabolic, psychiatric (e.g., substance abuse), other neurological, other serious medical conditions) impairing the ability to participate
- •inability to follow study procedures (e.g., due to language barriers)
- •suspected non-compliance
- •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
Functional mobility
时间窗: Change from baseline to directly after, 1-hour after, 3-hours after, and 5-hours after the exercise bout
Functional mobility is assessed by the Timed-Up-and-Go Test (TUG). For the TUG, participants are asked to get up from a chair, walk a 3 metres distance, perform a 180° turn, return to the chair, and sit down again as fast as possible. Assessment takes place on a single day, before (T0), 5 minutes after (T1), 60 minutes after (T2), 180 minutes after (T3), 300 minutes (T4) after HIIT/MCT cycling bout.
次要结局
- Spasticity (subjective)(Change from baseline to directly after, 1-hour after, 3-hours after, and 5-hours after the exercise bout)
- Gait pattern(Change from baseline to directly after, 1-hour after, 3-hours after and 5-hours after the exercise bout)
- Dexterity(Change from baseline to directly after, 1-hour after, 3-hours after, and 5-hours after the exercise bout)
- Spasticity (objective)(Change from baseline to directly after, 1-hour after, 3-hours after, and 5-hours after the exercise bout)
研究者
Jens Bansi
Dr. Jens Bansi, Head of Research and Development
Klinik Valens