Comparison the Home-based Pilates Exercises and the Combination of Home-based Pilates Exercises With Home-based Cognitive Rehabilitation Exercises on Executive Functions and Anxiety in Multiple Sclerosis Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- change from baseline total time of cTOL
研究概览
简要总结
The main purpose of this study is to evaluate the effectiveness of home-based Pilates exercises and the combination of home-based Pilates exercises with home-based cognitive rehabilitation exercises, also to compare the effects of these two home-based interventions on executive functions and anxiety in MS patients. 51 MS patients of Isfahan MS society will be considered as sample and will be divided randomly into three groups of 17 participants. The first group is home-based Pilates exercises group, the second group is a combination of home-based Pilates exercises and home-based cognitive rehabilitation exercises and the third group is the waiting list group that is considered as the control group. Patients' scores on executive functions and anxiety will be assessed before and after 8 weeks of intervention.
详细描述
Since the onset of pandemic conditions in 2020 and the increase of lockdowns, almost all rehabilitation programs for MS patients in Iran were suspended, it is necessary to study the effects of home-based cognitive and physical interventions to improve executive functions and anxiety in MS patients. The present study will be conducted to investigate the effects of home-based Pilates exercises and the combination of home-based Pilates exercises with home-based cognitive rehabilitation as well as to compare the effects of these two interventions on executive functions and anxiety in MS patients. In this study, participants will be divided into two experimental groups and a control group. The research process and the reason for conducting the research will be explained to the candidates by lead researcher and the final participants will sign the research participation form. All 51 final participants will be identified by a code and their identity information will not be disclosed, and in order to avoid any bias, each code will be randomly divided into three groups randomly. Pre-test will be taken from all three groups before the intervention. Experiment group 1 will perform a home-based Pilates video training program for 8 weeks, two sessions a week at home, and will also pay attention to exercise-related tips for MS patients determined by specialists. At the same time, Experiment group 2 will be asked to perform home-based cognitive rehabilitation program for 8 weeks, 3 seasons a week at home, in addition to home-based Pilates exercises same as experimental group 1. Group 3 will also be on the waiting list as a control group and will not receive any interventions for 8 weeks. At the end of 8 week intervention, Pilates training packages and cognitive exercises will be provided to the control group for their own use. During the 8 weeks of the intervention, the Pilates instructor and the cognitive rehabilitation specialist will contact the subjects on a weekly basis and monitor their performance. Subjects will also be able to contact the researchers and express their questions and problems. Also, they will be able to hold online meetings with research facilitators for solving the problems and educating the exercises. During the 8 weeks of the intervention, if subjects have problems such as COVID-19 affection, coronary heart disease, muscle problems, relapse, and failure to perform more than 4 sessions of exercise, they will be excluded from the study by the lead researcher. In order to fully perform the exercises for people who do not perform up to 4 sessions of exercises, 2 weeks can be added to the intervention period, which will be applied by the lead researcher. After complete implementation of the intervention, post-test will be taken from all 3 groups and the results will be compared to the baseline and relative to each other.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The principal investigator was blinded to participant allocation, and the analyses were performed blinded to the group. Participants' individual identification numbers assigned at baseline were used during the course of the trial. Identifying information were removed, such that no participant could be identified in the working dataset through one, or a combination of different variables.
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
- •physician-diagnosed Multiple Sclerosis
- •EDSS score < 5
- •Free from any other significant physical or psychiatric condition
- •Have no previous Pilates experience
排除标准
- •having cognitive or physical exercises at least from 3 months before intervention.
- •Using psychiatric drugs or being under psychotherapy.
结局指标
主要结局
change from baseline total time of cTOL
时间窗: Baseline, week 8
Computerized Tower Of London Task (cTOL) a computerized program in which patients are shown two pictures simultaneously of a goal board and a test board and are instructed to use the fewest possible moves to match the two boards. Each baseline and 8 week set of 12 problems consists of the same number of 2, 3, 4 or 5 move problems and has the same average difficulty level. Every problem could be repeated 3 times to be solved by participants. The dependent variables are the total number of task and the total time spent solving the problem (less time is better) and the delayed time or time to first move (less time is better).
change from baseline score of BAI
时间窗: Baseline, week 8
Beck Anxiety Inventory (BAI) Beck Anxiety Inventory (BAI) is a 21-item self-reported questionnaire which measures the existenceand severity of symptoms of anxiety. Each of the 21 items on BAI tool represents an anxiety symptom. A total score of 0 - 7 is interpreted as a "Minimal" level of anxiety; 8 - 15 as "Mild"; 16 - 25 as "Moderate", and 26 - 63 as "Severe".
change from baseline total number of cWMI
时间窗: Baseline, week 8
Computerized Working Memory Index (cWMI) The computerized figures width subscale of the Wechsler IQ scale, is used to measure working memory. Figures Width is the working memory subscale of the fourth edition of the Wechsler Intelligence Scale, which consists of two parts: Forward Figures Width and Inverted Figures Width and The sum of a person's scores in these two parts constitutes the total score of the person in this subscale.
次要结局
未报告次要终点
研究者
Amir Hossein Kazemi
MSc. University of Arak
Arak University of Medical Sciences