A Task-oriented Circuit Training in Multiple Sclerosis: a Multicentric Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Six-Minute Walking Test
研究概览
简要总结
Our primary hypothesis is that a two weeks high-intensity task-oriented circuit training followed by a structured 3 months home exercise program would have higher benefits compared to a delayed-treatment group as control in people with multiple sclerosis and mild to moderate gait impairment.
Our secondary hypothesis is that there could be retention of clinical gains in subjects that underwent TOCT plus structured 3 months home exercise program.
详细描述
This is a single blind randomized-controlled trial to test the effects of a task oriented training on locomotor function, mobility and balance in multiple sclerosis subjects with mild to moderate gait impairments (EDSS 4-5.5).
Subjects and methods:54 multiple sclerosis patients will be recruited in two outpatient rehabilitation clinics (Azienda Ospedaliero- Universitaria di Ferrara and Azienda Ospedaliero-Universitaria Pisana). Informed consent will be obtained. Participants enrolled will be included in 2 different treatment groups: experimental group will receive 10 TOCT sessions over 2 weeks (2 hours/each session) followed by a 3 months home exercise program, whereas control group will be included into a delayed-treatment group. Three subjects with a supervisor physiotherapist will take part at the TOCT. Primary outcome measure will be walking endurance (Six Minute Walking Test); as secondary outcome we will test gait speed (Timed 25-Foot Walk), balance (Dynamic Gait Index) and mobility (Time Up and Go Test); through self-assessment questionnaires we will evaluate motor fatigue (Modified Fatigue Impact Scale - MFIS), walking ability (Multiple Sclerosis Walking Scale - 12), health-related quality of life (Multiple Sclerosis Impact Scale - 29 and Functional Assessment of Multiple Sclerosis). In addition to clinical outcomes, in a convenience sample we will have: (i) balance assessment (force platform); (ii) motorcortex oxygenation during walking (fNIRS); (iii) muscle oxygenation (NIRS); (iv) force and EMG signal; (v) mechanical and electrical fatigue assessment; (vi) brain connectivity (EEG). Outcome measures will be assessed 1 week prior to treatment initiation (T0), after two weeks to treatment initiation (T1), after the 3 months exercise program (T2) and at 3 months follow-up (T3) to evaluate treatments retention, by a clinician blinded to the treatment.
The specific aims will be (i) to test the effects on walking, mobility, balance, fatigue and health-related quality of life; (ii) to test the effects on cerebral oxygenation (fNIRS) during walking; (iii) muscle oxygenation (NIRS); (iv) force and EMG signal; (v) Mechanical and electrical fatigue assessment; (vi) brain connectivity (EEG) and (vii) to investigate the 3 months home exercise program's feasibility, satisfaction and adherence.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •males and females,
- •community dwelling,
- •age >18 and <75
- •diagnosis of multiple sclerosis in a stable phase, with relapses > 3 months prior to study enrollment
- •moderate gait impairments referred to Expanded Disability Status Scale (EDSS) between 4 and 5,5
- •MMSE >24
排除标准
- •neurologic conditions in addition to multiple sclerosis that may affect motor function
- •medical conditions likely to interfere with the ability to safely complete the study
- •pregnancy
研究组 & 干预措施
Task Oriented Circuit Training
TOCT includes six different workstations in which subjects exercise for 5 minutes in each one (3 minutes of exercise and 2 minutes of rest). During each session, subjects undergo 2 laps that take about 60 minutes (6 workstation × 5 minutes × 2 laps), with 10 minutes of rest after each lap. In addition, walking endurance is trained by 30 minutes walking on the treadmill including rests if necessary. This is a progressive circuit and subjects while exercising receive feedbacks (visual and auditory) by the physiotherapist. Rests are used to discuss about difficulties and to provide further feedbacks. One session includes up to 3 patients and lasts 120 minutes, 5 days/week for 2 weeks. After this period they will receive a home-exercise maintenance program for 3 months.
干预措施: Task Oriented Circuit Training (Behavioral)
Delayed Onset TOCT
The control group will not receive any specific rehabilitation treatment for gait performance and mobility improvement. At any case, the control group will be authorized, at will, to exercise in non-rehabilitative contexts (i.e. swimming, walking, yoga) for 14 weeks. After this period they will receive TOCT as treatment plus a home-exercise maintenance program for 3 months.
干预措施: Delayed Onset TOCT (Behavioral)
结局指标
主要结局
Six-Minute Walking Test
时间窗: Weeks: 0,2,14, 26
The walking endurance is measured with the Six-Minute Walking Test. Subjects are instructed to walk up and down as far as possible a 22m walkway in six minutes, with the possibility to slow down and rest if necessary.
次要结局
- Multiple Sclerosis Walking Scale - 12 (MSWS-12)(weeks: 0,2,14, 26)
- Timed 25-Foot walk (25FWT)(weeks: 0,2,14, 26)
- Time Up and Go Test(weeks: 0,2,14, 26)
- Dynamic Gait Index (DGI)(weeks: 0,2,14, 26)
- Modified fatigue impact scale (MFIS)(weeks: 0,2,14, 26)
- Multiple Sclerosis Impact Scale- 29 (MSIS-29)(weeks: 0,2,14, 26)
- Functional Assessment of Multiple Sclerosis (FAMS)(weeks: 0,2,14, 26)
- Metabolic cerebral measurements by Near infrared spectroscopy(weeks: 0,2,14, 26)
- Postural sway (Center of pressure (COP) trajectories)(weeks: 0,2,14, 26)
- Force and EMG signal (perform an isometric extension of the knees on an isokinetic dynamometer (PrimusRS BTETM Technology), achieving their own Maximum Voluntary Contraction (MVC)(weeks: 0,2,14, 26)
- Mechanical and electrical fatigue assessment (evaluated measuring sustained contractions in isometric tasks in lower limbs on an isokinetic dynamometer (PrimusRS BTETM Technology)(weeks: 0,2,14, 26)
- Brain plasticity and connectivity (High density EEG and vertical electrooculogram (EOG) will be recorded with a standard bipolar 64-channels montage and a DC-coupled amplifier (Micromed SD MRI, System Plus acquisition software)(weeks: 0,2,14, 26)
- Metabolic muscular measurements by Near infrared spectroscopy(weeks: 0,2,14, 26)