Effectiveness of Structured Exercise Program on Quality of Life and Activities of Daily Living in Persons With Multiple Sclerosis: Telerehabilitation vs Supervised Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Functional Independence Measure (FIM)
研究概览
简要总结
Multiple sclerosis (MS) is a complex neurodegenerative autoimmune disease. People with MS (PwMS) have low quality of life (QoL) and activities of daily living (ADL). Exercise is a safe and effective rehabilitation tool for PwMS. A structured and personalized exercise program can improve physical fitness, functional capacity, quality of life and modifiable disorders in PwMS. On the other hand, Telerehabilitation is an alternative rehabilitation method in PwMS. The purpose of this study is to investigate the effectiveness of exercise programs and telerehabilitation on ADL and QoL in PwMS, and compare the effects of supervised exercise and home-based exercise programs for the PwMS.
详细描述
Participants are randomly assigned to the structured supervised exercise or structured home-based groups. Interventions in Group 1 (n=15) includes one session per day, 3 days a week over a 12-weeks structured exercise program under the supervision of a physical therapist. Group 2 (n=15) includes a 12-week structured home-based exercise program checked and controlled through telerehabilitation three times a week. All measurements pre-post intervention.
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 (Participant)
盲法说明
Participants will randomly assign to the structured supervised exercise or structured home-based groups. Randomization are done using Microsoft Excel 'RAND()' function.
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with:
- •Stable period at the time of application to the clinic
- •Expanded Disability Status Scale Levels between 2 - 6.5
- •Appropriate cognitive level to understand the exercises
- •No diseases to affect their participation in exercise programs
排除标准
- •patients with:
- •Poorly controlled diabetes, hypertension or other medical conditions to be incompatible with study participation,
- •A new history of previous attacks
- •No reliable informed consent
研究组 & 干预措施
Supervised Exercise Group
One session per day, 3 days per week over a 12-weeks structured exercise program under supervision of a physical therapist.
干预措施: Structured Supervised Exercise (Behavioral)
Telerehabilitation Group
One session per day, 3 days per week over a 12-weeks structured exercise program through Telerehabilitation
干预措施: Structured telerehabilitation (Behavioral)
结局指标
主要结局
Functional Independence Measure (FIM)
时间窗: Changes after 12 weeks
FIM is a tool used for evaluation of primary ADL of people with disability. FIM items include self care, sphincter control, transfers, locomotion, communication, and social cognition subgroups. Grading is based on 7 points. 7: complete independence, 6: modified independence, 5, 4 and 3: modified dependence, 2 and 1: complete dependence.
Quality of life scale (QoLS)
时间窗: Changes after 12 weeks
QoLS is a standardized interview consisting of 41 questions clustered in four subscales: functional and economic scale, social and recreational scale, affect and life in general scale, and medical problems scale. Each question in the scale is evaluated over 5 points. (1 is negative at all times and 5 is the best response).
Nottingham Health Profile, First section (NHP-I)
时间窗: Changes after 12 weeks
NHP is a tool used for measuring and definition of QoL regarding the health status in general. NHP-I contains 38 yes/no statements, focusing on different aspects of the general health problems, including six dimensions of subjective health defined as physical abilities, pain, sleep, energy, emotional reaction, energy level and social isolation. Questions are evaluated according to the patients' yes/no responses and are scored between 0 and 100. High scores indicate high level health status in the specified item. Total scores are summed in all fields.
次要结局
未报告次要终点
研究者
Ela Tarakci
Professor
Istanbul University - Cerrahpasa (IUC)