Measuring the Effect of Using the Arabic Otago Exercise Program on Falls and Falls-related Factors in People With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Incidence of falls
研究概览
简要总结
People with multiple sclerosis (MS) need exercise training programs throughout their life in order to prevent secondary complications of the disease. Coronavirus disease of 2019 (COVID-19) forced people with chronic disorders to stay at home in order to prevent the transmission of the virus. Therefore, people with MS now are facing a new challenge in going outside their home to perform their rehabilitation sessions. One of the solutions to keep them exercising is a home-based exercise program and one of the home exercise programs that are well validated in older adults is the Otago exercise program (OEP). Investigators suggest that the balance would improve and fall incidences would reduce using the OEP in people with MS compared to health awareness videos only.
50 participants with confirmed diagnosis of MS will be recruited in both groups. Using a randomized controlled trial this study aims to examine the effectiveness of the OEP compared to a control group that gets health awareness videos only on falls and falls-related factors in people with MS.
详细描述
Ethical consideration:
This study got the ethics approval from the deanship of scientific research ethical committee at University of Jordan. A consent form that contains the study procedures will be prepared and signed from all patients.
Design:
This will be a single blinded randomized controlled trial study with 2 groups. The treatment group will receive the OEP for 8 weeks plus health awareness videos about topics related to MS. The control group will receive only the same health awareness videos. The health awareness videos will be video-recorded by a health-care provider then sent to all participants on weekly basis.
Participants:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18 years and older.
- •Both genders
- •All types of multiple sclerosis.
- •Independent in ambulation even with the use of an assistive device.
- •An Expanded Disability Status Scale (EDSS) score ≤ 6.5.
排除标准
- •The diagnosis of other neurological or musculoskeletal disorders that affect balance.
- •If the patient had a relapse within that last four weeks.
- •wheelchair users.
- •If the patient is engaged in any exercise program.
研究组 & 干预措施
Otago Exercise Program
Patients will receive the Otago Exercise Program for 8 weeks plus health awareness videos about topics related to MS.
干预措施: Otago Exercise Program (Other)
Control group
Patients will receive health awareness videos only about topics related to MS.
结局指标
主要结局
Incidence of falls
时间窗: 12 months post intervention.
The effect of the intervention on the incidence of falls.
Incidence of falls
时间窗: 2 months post intervention.
The effect of the intervention on the incidence of falls.
Incidence of falls
时间窗: 6 months post intervention.
The effect of the intervention on the incidence of falls.
次要结局
- Quadriceps strength (using a dynamometer)(2 months post intervention.)
- the Quality of sleep (Using Pittsburgh Sleep Quality Index)(2 months post intervention.)
- Balance (using Chair balance test and Four test balance scale)(2 months post intervention.)
- Cognitive ability (using Montreal Cognitive Assessment)(2 months post intervention.)
- The Quality of Life (using Medical Outcomes Study Short Form 12)(2 months post intervention.)
- Fear of Falling (using the Falls Efficacy Scale-International )(2 months post intervention.)
- Mobility (using Timed-Up and go)(2 months post intervention.)
- The severity of fatigue (using Modified Fatigue Impact Scale)(2 months post intervention.)
- the severity of Anxiety and Depression (using Hospital Anxiety and Depression Scale)(2 months post intervention.)
研究者
Alia A. Alghwiri
Professor
University of Jordan