The Effect of Aerobic Exercise on an Elliptical Trainer Versus a Treadmill, on Gait and Walking Abilities, Expressed in Dynamic Stability, Balance and Walking Speed, in People With Multiple Sclerosis (MS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Quality of life outcomes
研究概览
简要总结
The aim of this study is to examine the effects of aerobic exercise training using an elliptical trainer compared to a treadmill on gait and walking abilities, expressed in dynamic stability, balance, and walking speed, in people with Multiple Sclerosis with moderate severity.
详细描述
A total of 30 MS subjects to be enrolled in the study. Subjects to be assigned into one of two groups named: Group 1 - Elliptical Training and Group 2 - Treadmill Training. Effort capacity will measured by heart rate and RPE.
Outcome measures will be measured by using, 6 min. walking test (6MWT), Timed Up & Go (TUG), Berg Balance Scale (BBS) and 10 Meter Walk Test (10MWT) to be used to assess the quality of life at Baseline (T0), During study - 6 weeks from baseline (T1), End of training program - 12 weeks from baseline (T2) and 6 weeks post T2 (T3).
The exercise program to be applied for 12 weeks with 2 trainings per week.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients signed Informed Consent Form
- •At least 6 months post MS diagnosis
- •25-55 years old adults
- •EDSS 3.0-6.5
- •Standing stability - for at least 30 seconds
- •6MWT - minimal distance to be measured as 210 meters
- •No physical routinely training e.g. walking, elliptical or cycling within 3 months prior screening visit.
排除标准
- •Active Heart Disease
- •Lungs and/or respiratory system diseases
- •Metabolic Disease
- •Any other medical condition(s) which might impact the patient's participant in the study, as per PI medical judgement
- •Major medical treatment change (as per PI medical judgement) up to 12 weeks prior ICF signature by the patient.
研究组 & 干预措施
Group 1 - Elliptical Trainer
15 MS subjects will be enrolled and assigned to group 1 and to be trained (Elliptical Trainer) twice a week for 12 weeks.
干预措施: Physical Training (Other)
Group 2 - Treadmill
15 MS subjects will be enrolled and assigned to group 2 and to be trained (Treadmill) twice a week for 12 weeks.
干预措施: Physical Training (Other)
结局指标
主要结局
Quality of life outcomes
时间窗: Baseline (screening), T1 (Week 6), T2 (Week 12), T3 (Follow-up, 6 weeks post T2)
Quality of life to be assessed by using a Short-form 36 health status questionnaire (SF-36). SF-36 consists of 36 questions in total. Each participant will be asked to fill in the questionnaire alone and by reading it themselves.
次要结局
- 6 Minute Walk Test (6MWT)(Baseline (screening), T1 (Week 6), T2 (Week 12), T3 (Follow-up, 6 weeks post T2))
- Timed Up & Go (TUG)(Baseline (screening), T1 (Week 6), T2 (Week 12), T3 (Follow-up, 6 weeks post T2))
- Berg Balance Scale (BBS)(Baseline (screening), T1 (Week 6), T2 (Week 12), T3 (Follow-up, 6 weeks post T2))
- 10 Meter Walk Test (10MWT)(Baseline (screening), T1 (Week 6), T2 (Week 12), T3 (Follow-up, 6 weeks post T2))
研究者
Iuly Treger, M.D., PhD, MHA
Principal Investigator, Head of Rehabilitation Department
Soroka University Medical Center