Effects of a Circuit Training on Balance Management in a State of Fatigue in Persons With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Change from Baseline Modified Fatigue Impact Scale at 6-8 weeks
研究概览
简要总结
The aim of the study is to evaluate the effects of a circuit training rehabilitation program on the perceived impact of fatigue in daily life situations and on gait and balance. Half of the participants will follow the circuit training program, while the other half will follow usual care rehabilitation programs.
详细描述
Approximately 80% of Persons with Multiple Sclerosis rates fatigue among the three most disabling symptoms. Aerobic, balance and strength training have already been proved effective in rehabilitation, especially for Persons with Multiple Sclerosis. Fifty-two Persons with Multiple Sclerosis will be randomly allocated to an experimental group or to a control group following usual care rehabilitation programs. Experimental group will follow a circuit training rehabilitation program which combines high intensity aerobic training with balance and strength training. The study aims to verify the effects of the circuit training program on fatigue and on balance in different contexts with respect to usual care rehabilitation programs and to investigate effects of rehabilitation on immunological markers.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Definite diagnosis of Multiple Sclerosis (Polman criteria);
- •No relapses in the previous three months;
- •Expanded Disability Status Scale < 6,5;
- •Able to walk 20 meter with or without an assistive device;
- •Able to stand for 30 second without aid;
- •MiniMental State Examination >20;
排除标准
- •Unable to understand the aim of the study or unable to sign the informed consent form;
- •Subjects following a steroidal drug therapy or assuming drugs affecting cardiac function;
- •Subjects with psychiatric disorders;
- •Subjects with cardiovascular diseases for whom aerobic training is forbidden;
结局指标
主要结局
Change from Baseline Modified Fatigue Impact Scale at 6-8 weeks
时间窗: Baseline and at 6-8 weeks (after the completion of 16 training sessions)
Provides an assessment of the effects of fatigue in terms of physical, cognitive and psychosocial functioning. Participant rates on a 5 point Likert scale (from 0="never" to 4= "Almost Always") their agreement with 21 statements. Higher numbers indicate greater fatigue.
次要结局
- Change from Baseline 5-Time-Sit-To-Stand at 6-8 weeks(Baseline and at 6-8 weeks (after the completion of 16 training sessions))
- Change from Baseline 10 Meter Walking Test at 6-8 weeks(Baseline and at 6-8 weeks (after the completion of 16 training sessions))
- Change from Baseline Hospital Anxiety and Depression Scale at 6-8 weeks(Baseline and at 6-8 weeks (after the completion of 16 training sessions))
- Change from Baseline Modified Dynamic Gait Index at 6-8 weeks(Baseline and at 6-8 weeks (after the completion of 16 training sessions))
- Change from Baseline 6 Minutes Walking Test at 6-8 weeks(Baseline and at 6-8 weeks (after the completion of 16 training sessions))
- Change from Baseline 12 item Multiple Sclerosis Walking Scale at 6-8 weeks(Baseline and at 6-8 weeks (after the completion of 16 training sessions))