Examination of the Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis: A Randomized Controlled Single-Blind Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Fatigue Severity Scale
研究概览
简要总结
Multiple Sclerosis (MS) is a chronic, inflammatory, neurodegenerative, and autoimmune disease that progresses with progressive neurological dysfunction and affects the central nervous system. A multidisciplinary rehabilitation approach is crucial in the systematic and supportive treatment of MS. Exercise training is a therapeutic approach that minimizes functional capacity loss and slows progression in MS. Randomized controlled studies have shown that exercise training improves physical fitness, reduces motor fatigue, and improves the quality of life and psychological state in individuals with MS.
When the literature is examined, it is seen that popular exercises such as pilates, yoga, and Tai-Chi are used in addition to aerobics, strengthening, endurance, and stretching exercises in the treatment of individuals with MS. In order to eliminate the economic burden, which is one of the exercise barriers of individuals, and to gain exercise habits, home exercise programs should be expanded. When the literature is examined, it is emphasized that the importance of home exercise programs is emphasized, and it is very important in the treatment of patients who cannot attend an exercise program, especially by going to any center for various reasons. However, there is little information on the effectiveness and content of home exercise programs in patients with MS. From this point of view, this study is capable of supporting the missing part of the literature.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be between the ages of 18-65
- •Being diagnosed with MS according to McDonald criteria
- •Having an EDSS score between 0-5.5
- •Being in the Relapsing Remitting class as a clinical subtype of MS
- •Not having any nervous system pathology other than MS
- •Not having an MS attack in the last 1 month
- •To ensure full cooperation and adaptation throughout the study.
排除标准
- •Being in an exacerbation period
- •To have participated in a regular physical activity program in the last 6 months
- •Having an orthopedic, cardiopulmonary or psychiatric disease that prevents exercise
- •Continuing another exercise therapy
- •Not volunteering to participate in the study
- •Having problems with reading comprehension
研究组 & 干预措施
Control Group (CG)
The control group will be queued to be included in the exercise program and participants' routine treatment will continue.
干预措施: Time up and go- 25 steps walking test (Other)
Control Group (CG)
The control group will be queued to be included in the exercise program and participants' routine treatment will continue.
干预措施: Multiple Sclerosis Quality of Life (Other)
Control Group (CG)
The control group will be queued to be included in the exercise program and participants' routine treatment will continue.
干预措施: Brief International Cognitive Assessment for MS (BICAMS) (Other)
Control Group (CG)
The control group will be queued to be included in the exercise program and participants' routine treatment will continue.
干预措施: Beck Depression and Anxiety Scale (Other)
Video Group (VG)
The exercise will be given as a video and participants will be asked to continue the exercises for 8 weeks, 3 days a week. Patients will be contacted by phone every week to ask if participants have any problems with the exercise program and their compliance.
干预措施: Fatigue Severity Scale (Other)
Video Group (VG)
The exercise will be given as a video and participants will be asked to continue the exercises for 8 weeks, 3 days a week. Patients will be contacted by phone every week to ask if participants have any problems with the exercise program and their compliance.
干预措施: Berg Balance Test (Other)
Video Group (VG)
The exercise will be given as a video and participants will be asked to continue the exercises for 8 weeks, 3 days a week. Patients will be contacted by phone every week to ask if participants have any problems with the exercise program and their compliance.
干预措施: Time up and go- 25 steps walking test (Other)
Control Group (CG)
The control group will be queued to be included in the exercise program and participants' routine treatment will continue.
干预措施: Fatigue Severity Scale (Other)
Control Group (CG)
The control group will be queued to be included in the exercise program and participants' routine treatment will continue.
干预措施: Berg Balance Test (Other)
Video Group (VG)
The exercise will be given as a video and participants will be asked to continue the exercises for 8 weeks, 3 days a week. Patients will be contacted by phone every week to ask if participants have any problems with the exercise program and their compliance.
干预措施: Multiple Sclerosis Quality of Life (Other)
Video Group (VG)
The exercise will be given as a video and participants will be asked to continue the exercises for 8 weeks, 3 days a week. Patients will be contacted by phone every week to ask if participants have any problems with the exercise program and their compliance.
干预措施: Brief International Cognitive Assessment for MS (BICAMS) (Other)
Video Group (VG)
The exercise will be given as a video and participants will be asked to continue the exercises for 8 weeks, 3 days a week. Patients will be contacted by phone every week to ask if participants have any problems with the exercise program and their compliance.
干预措施: Beck Depression and Anxiety Scale (Other)
Brochure Group (BG)
Exercise will be given as a brochure and participants will be asked to continue the exercises given for 8 weeks, 3 days a week. Visual feedback will be provided by asking participants to mark the exercise tracking chart on the exercise brochures.
干预措施: Fatigue Severity Scale (Other)
Brochure Group (BG)
Exercise will be given as a brochure and participants will be asked to continue the exercises given for 8 weeks, 3 days a week. Visual feedback will be provided by asking participants to mark the exercise tracking chart on the exercise brochures.
干预措施: Berg Balance Test (Other)
Brochure Group (BG)
Exercise will be given as a brochure and participants will be asked to continue the exercises given for 8 weeks, 3 days a week. Visual feedback will be provided by asking participants to mark the exercise tracking chart on the exercise brochures.
干预措施: Time up and go- 25 steps walking test (Other)
Brochure Group (BG)
Exercise will be given as a brochure and participants will be asked to continue the exercises given for 8 weeks, 3 days a week. Visual feedback will be provided by asking participants to mark the exercise tracking chart on the exercise brochures.
干预措施: Multiple Sclerosis Quality of Life (Other)
Brochure Group (BG)
Exercise will be given as a brochure and participants will be asked to continue the exercises given for 8 weeks, 3 days a week. Visual feedback will be provided by asking participants to mark the exercise tracking chart on the exercise brochures.
干预措施: Brief International Cognitive Assessment for MS (BICAMS) (Other)
Brochure Group (BG)
Exercise will be given as a brochure and participants will be asked to continue the exercises given for 8 weeks, 3 days a week. Visual feedback will be provided by asking participants to mark the exercise tracking chart on the exercise brochures.
干预措施: Beck Depression and Anxiety Scale (Other)
结局指标
主要结局
Fatigue Severity Scale
时间窗: Baseline- after 8 weeks (after treatment)
The Fatigue Severity Scale questionnaire contains nine statements that rate the severity of fatigue symptoms. A total score of less than 36 suggests that patient may not be suffering from fatigue. A higher score is indicated high level of fatigue.
Timed up and go with 25 steps walking test
时间窗: Baseline- after 8 weeks (after treatment)
Timed up and go: Patients wear their regular footwear and can use a walking aid, if needed. 1. The patient starts in a seated position 2. The patient stands up upon therapist's command: walks 3 meters, turns around, walks back to the chair and sits down. 3. The time stops when the patient is seated. 4. Be sure to document the assistive device used. Note: A practice trial should be completed before the timed trial. High falling risk\>13.5 seconds. The 25 steps walking test is a quantitative mobility and leg function performance test based on a timed 25-walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is recorded.
Brief International Cognitive Assessment for MS (BICAMS)
时间窗: Baseline- after 8 weeks (after treatment)
The Brief International Cognitive Assessment for MS (BICAMS) initiative was undertaken to recommend a brief, cognitive assessment for MS that is optimized for small centers. BICAMS was particularly focused on international use, to facilitate comparison across settings. An expert committee of twelve neurologists and neuropsychologists representing the main cultural groups that have so far contributed extensive data about cognitive dysfunction in MS was convened. The opinions generated from the meeting are published elsewhere. Consensus was also achieved on optimal measures for learning and memory in MS patients, time permitting: the initial learning trials of the second edition of the California Verbal Learning Test (CVLT2) and the revised Brief Visuospatial Memory Test (BVMTR).
Berg Balance Scale
时间窗: Baseline- after 8 weeks (after treatment)
The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. A score of 56 indicates functional balance. A score of \< 45 indicates individuals may be at greater risk of falling.
次要结局
- Mulitple Sclerosis Quality of life- 54(Baseline- after 8 weeks (after treatment))
- Beck Depression and Anxiety Scale(Baseline- after 8 weeks (after treatment))
研究者
Banu BAYAR
Principal investigator, Head of Physiotherapy and Rehabilitation Department, Pt. PhD. Prof.
Muğla Sıtkı Koçman University