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临床试验/NCT04413682
NCT04413682
已完成
不适用

Effectiveness of Structured Exercise Program on Quality of Life and Activities of Daily Living in Persons With Multiple Sclerosis: Telerehabilitation vs Supervised Program

Istanbul University1 个研究点 分布在 1 个国家目标入组 30 人2019年2月1日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Multiple Sclerosis
发起方
Istanbul University
入组人数
30
试验地点
1
主要终点
Functional Independence Measure (FIM)
状态
已完成
最后更新
5年前

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.

注册库
clinicaltrials.gov
开始日期
2019年2月1日
结束日期
2020年5月30日
最后更新
5年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Ela Tarakci

Professor

Istanbul University - Cerrahpasa (IUC)

入排标准

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

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.

研究点 (1)

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