Effect of Multimodal Exercise Training on Disease Activity and Functional Status in Patients With Multiple Sclerosis
概览
- 阶段
- 不适用
- 干预措施
- Multimodal Exercise Training
- 疾病 / 适应症
- Multiple Sclerosis
- 发起方
- Istanbul University - Cerrahpasa
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Multiple Sclerosis Functional Composite Test (The change between the initial value and the value after 3 months will be evaluated).
- 状态
- 招募中
- 最后更新
- 上个月
概览
简要总结
The study aims to examine the effects of multimodal exercise training including aerobic, strengthening and balance exercises via face-to-face and asynchronous video-based telerehabilitation on disease activity, disability level, aerobic capacity, physical activity level, balance, fatigue level and quality of life in individuals with multiple sclerosis. Therefore, this study consists of two hypotheses.
Hypotheses:
H0: Multimodal exercise training has no effect on disease activity and functional status in patients with multiple sclerosis H1: Multimodal exercise training has effects on disease activity and functional status in patients with multiple sclerosis
详细描述
Multiple sclerosis (MS) is a leading cause of disability in young adults, with symptoms varying based on lesion size, location, and disease course. These symptoms often worsen over time, significantly impacting quality of life. To manage symptoms and potentially affect disease activity, patients are often directed to exercise interventions, though the impact on disease progression is still being studied. Neuroimaging, particularly magnetic resonance imaging (MRI), is commonly used to monitor MS, but MRI does not reveal brain activation levels, which is why functional MRI is recommended for a more detailed evaluation. Exercise, both face-to-face and telerehabilitation (TR), is considered an effective treatment for MS. Studies show that TR increases patient adherence and can be as effective as in-person therapy. Our study aims to assess the effects of a multimodal exercise program combining face-to-face and TR on disease activity and functional status in patients with MS (PwMS). PwMS with an Expanded Disability Status Scale (EDSS) score of 3.0 to 5.5 will be randomly assigned to either the multimodal exercise training group (Group I) or a control group (Group II). Disease activity, disability, aerobic capacity, physical activity, balance, fatigue, and quality of life will be evaluated. Group I will participate in exercise training three days a week (one day in-person, two days TR) for 12 weeks. Group II will receive no exercise during this period and will be reassessed after 12 weeks.
研究者
Pelin Vural
Lecturer, Physiotherapist
Istanbul University - Cerrahpasa
入排标准
入选标准
- •Being diagnosed with multiple sclerosis by a neurologist
- •Volunteering to participate in the study
- •Being ambulatory
- •EDSS between 3.0-5.5
- •Being literate
- •Having internet access
- •Not having participated in a standardized physiotherapy and rehabilitation program in the last 3 months
排除标准
- •Having an orthopedic problem affecting its mobility
- •Having psychiatric problems, severe cognitive impairment, or epilepsy in addition to the MS diagnosis
- •Blurred vision or visual impairment
- •Pregnancy
- •Having had an attack or received corticosteroid treatment 3 months before participating in the study
- •Having a disease affecting immunological parameters (infection, cancer, etc.)
研究组 & 干预措施
Multimodal Exercise Training Group
Participants in the multimodal exercise training group will be given a treatment protocol consisting of aerobic exercise and strengthening exercises in the presence of a physiotherapist for a total of 12 weeks, 3 days a week for 1 hour.
干预措施: Multimodal Exercise Training
Control Group
Participants in the control group will be put on the waiting list after all assessment methods have been applied and will be re-evaluated at the end of 12 weeks.
干预措施: Control Group
结局指标
主要结局
Multiple Sclerosis Functional Composite Test (The change between the initial value and the value after 3 months will be evaluated).
时间窗: Baseline and end of weeks 12
The Multiple Sclerosis Functional Composite Test evaluates disease activity through three sections: cognitive status, and upper and lower extremity function. The Paced Auditory Serial Addition Test (PASAT) measures auditory processing speed, attention, flexibility, and calculation by having the patient add numbers presented at three-second intervals. The score is based on correct answers, with a maximum of 60 points. The Timed 25 Foot Walking Test (T25FWT) assesses lower extremity function by recording the time (in seconds) taken to walk 7.62 meters as quickly and safely as possible, with the average of two trials used for scoring. The 9-Hole Peg Test (9DPT) evaluates upper extremity function by having the patient place and remove nine pegs as quickly as possible, with scores based on the average of two trials for each hand.
Functional Magnetic Resonance Imaging (fMRI) (The change between the initial value and the value after 3 months will be evaluated).
时间窗: Baseline and end of weeks 12
fMRI is a non-invasive method that allows the examination of central nervous system function and the identification of abnormal activation patterns and/or functional connectivity caused by diseases (Rocca et al 2024).In our study, functional MRI evaluations are planned to be performed using parallel imaging sequences with a 3 T Siemens device with a 32-channel head coil. High-resolution (1 x 1 x 1 mm isotropic) sagittal 190 slices will be obtained with a T1-weighted imaging sequence (TR/TE: 7.7/3.7 ms;, FA: 8°; FOV: 256 x 256). Functional resting state data will be taken with a single-shot echo planar imaging (EPI) sequence consisting of 35 slices of 4 mm thickness, 300 dynamic shots (TR/TE: 2230/30 ms, FA: 77°; matrix: 80x80) and will last approximately 11 minutes. Before functional acquisition, magnetic field maps will be recorded in order to correct signal distortions caused by tissue inhomogeneities in the magnetic field during the analysis phase.
Brain-derived neurotrophic factor (BDNF) assessment (The change between the initial value and the value after 3 months will be evaluated).
时间窗: Baseline and end of weeks 12
BDNF is a neurotrophin that affects the survival, growth and function of neurons in the central and peripheral nervous system, provides stabilization of synapses, and regulates synaptic function, axon and dendrite branching. In our study, Enzyme-Linked Immunosorbent Assay (ELISA) will be used to assess the BDNF levels of participants. All participants will be asked not to consume alcohol and caffeine in the last 12 hours before blood collection, not to take any anti-inflammatory drugs other than their routine treatments and not to exercise. The blood samples to be collected will be centrifuged and stored at -80 degrees in Eppendorf or Falcon tubes (15 ml) (Shobeiri et al 2022; Briken et al. 2016). After the treatments are completed, the blood taken will be analyzed by experienced technicians in the laboratory together with the blood taken before exercise training.
次要结局
- The Expanded Disability Status Scale (EDSS) (The change between the initial value and the value after 3 months will be evaluated).(Baseline and end of weeks 12)
- 6 Minute Walk Test (6MWT) (The change between the initial value and the value after 3 months will be evaluated).(Baseline and end of weeks 12)
- ActiGraph wGT3X-BT (The change between the initial value and the value after 3 months will be evaluated).(Baseline and end of weeks 12)
- The Godin Leisure-Time Exercise Questionnaire (The change between the initial value and the value after 3 months will be evaluated).(Baseline and end of weeks 12)
- Balance Assessment (The change between the initial value and the value after 3 months will be evaluated).(Baseline and end of weeks 12)
- Fatigue Severity Scale (The change between the initial value and the value after 3 months will be evaluated).(Baseline and end of weeks 12)
- Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) (The change between the initial value and the value after 3 months will be evaluated).(Baseline and end of weeks 12)