Telerehabilitation, Face-to-Face and Home-Based Spinal Stabilization Exercise Training in Patients With Spondyloarthritis
Comparison of the Effects of Telerehabilitation, Face-to-Face and Home-Based Spinal Stabilization Exercise Training in Patients With Spondyloarthritis
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Nur B Karaca
- 电话号码：+905448844755
- 邮箱：nurturkmen90@gmail.com
学习地点
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Ankara、火鸡
- Hacettepe University, Faculty of Physical Therapy and Rehabilitation
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接触：
- Özlem Ülger, professor
- 电话号码：+905324027876
- 邮箱：ozlem.ulger@hacettepe.edu.tr
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Diagnosed with spondyloarthritis
- Between the ages of 18-65,
- Literate,
- Having sufficient smartphone/computer knowledge to participate in the study or having a relative who can help in this regard,
- Having a smart phone/computer and an active internet connection,
- Individuals who have not exercised regularly in at least the last 3 months will be included in the study.
Exclusion Criteria:
- Having a diagnosis of uncontrolled/clinically significant other disease (chronic obstructive pulmonary disease, congestive heart failure, endocrine system diseases, neurological, psychological diseases, etc.),
- Malignancies
- Having a history of previous surgery on the spine and extremities and therefore loss of function,
- Pregnant individuals,
- Continuing another rehabilitation program,
- Have other conditions that prevent exercise,
- Individuals who do not agree to participate in the study and do not give written consent will be excluded from the study.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Telerehabilitation Training Group
In the telerehabilitation group, an individualized rehabilitation program according to the principles of spinal stabilization exercises will be applied via video conference, 3 days a week, 1 hour, online in real-time, accompanied by a physiotherapist, for 8 weeks. In the first session, informative training about the disease (pathophysiology of spondyloarthritis, its course, physical structures it covers, etc.), pain management training (information about the relationship between pain, muscle spasm, stress, depression, methods that can be used for coping with pain, etc.), exercise. The importance of exercise training (trunk stabilization, anatomy) and aims will be given within the scope of patient education. |
Spinal stabilization exercises aim at controlling the position of the trunk over the pelvis to provide optimal energy production and energy transfer to distal segments and involve the cocontraction of muscles, which may restore stability to the spine.
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实验性的：Face-to-Face Training Group
In the face-to-face training group, an individualized rehabilitation program according to the principles of spinal stabilization exercises will be applied in the clinic under the supervision of a physiotherapist for 1 hour, 3 days a week, for 8 weeks. In the first session, informative training about the disease (pathophysiology of spondyloarthritis, its course, physical structures it covers, etc.), pain management training (information about the relationship between pain, muscle spasm, stress, depression, methods that can be used for coping with pain, etc.), exercise. The importance of exercise training (trunk stabilization, anatomy) and aims will be given within the scope of patient education. |
Spinal stabilization exercises aim at controlling the position of the trunk over the pelvis to provide optimal energy production and energy transfer to distal segments and involve the cocontraction of muscles, which may restore stability to the spine.
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实验性的：Home-Based Training Group
In the home exercise group, patients will be asked to perform individualized spinal stabilization exercises at home, 3 days a week, for 8 weeks. In the first session, informative training about the disease (pathophysiology of spondyloarthritis, its course, physical structures it covers, etc.), pain management training (information about the relationship between pain, muscle spasm, stress, depression, methods that can be used for coping with pain, etc.), exercise. The importance of exercise training (trunk stabilization, anatomy) and aims will be given within the scope of patient education. |
Spinal stabilization exercises aim at controlling the position of the trunk over the pelvis to provide optimal energy production and energy transfer to distal segments and involve the cocontraction of muscles, which may restore stability to the spine.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Evaluation of Disease Activity
大体时间：3 minutes, through study completion, an average of 8 weeks, change from baseline disease activity at 8 weeks.
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Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): The index consists of 6 items questioning 5 symptoms in total.
The response of each item is evaluated with the Visual Analog Scale (VAS).
A total score of ≥ 4 indicates active disease.
Turkish version study Akkoç et al. made by.
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3 minutes, through study completion, an average of 8 weeks, change from baseline disease activity at 8 weeks.
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Evaluation of Functional Level
大体时间：5 minutes, through study completion, an average of 8 weeks, change from baseline functional level at 8 weeks.
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Bath Ankylosing Spondylitis Functional Index (BASFI): The index consists of 10 questions in total.
For each item, the patient marks the VAS consisting of a 100 mm line.
The score range is 0-100.
The Turkish version study was conducted by Karatepe et al. made by.
A high score indicates a bad result.
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5 minutes, through study completion, an average of 8 weeks, change from baseline functional level at 8 weeks.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Evaluation of Spinal Mobility and Hip Function
大体时间：10 minutes, through study completion, an average of 8 weeks, change from baseline spinal mobility and hip function at 8 weeks.
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Bath Ankylosing Spondylitis Metrology Index (BASMI): The index, which consists of five clinical measurements, namely cervical rotation, tragus-wall distance, lumbar lateral flexion, modified Schober's test, and intermalleolar distance, is accepted as the most valid method for evaluating the axial skeleton.
The higher the BASMI score the more severe the patient's limitation of movement.
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10 minutes, through study completion, an average of 8 weeks, change from baseline spinal mobility and hip function at 8 weeks.
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Assessment of Health and Disability Status
大体时间：5 minutes, through study completion, an average of 8 weeks, change from baseline health and disability status at 8 weeks.
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Health Assessment Questionnaire (HAQ): It consists of 20 questions that question daily activities under 8 headings.
Each question is scored between 0-3 by the patient.
The total score ranges from 0-3.
Turkish version study Küçükdeveci et al. made by.
A high score indicates a bad result.
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5 minutes, through study completion, an average of 8 weeks, change from baseline health and disability status at 8 weeks.
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Evaluation of Quality of Life
大体时间：5 minutes, through study completion, an average of 8 weeks, change from baseline quality of life at 8 weeks.
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Short Form-36 (SF-36): SF-36, which is one of the most commonly used general scales to measure the quality of life, consists of eight sub-dimensions: physical function, social function, role limitations due to physical problems, role limitations due to emotional status, pain, vitality, mental health, and general health perception.
Each sub-dimension is scored between 0-100 in itself.
A high score indicates good health.
The Turkish version study was conducted by Koçyiğit et al. made by.
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5 minutes, through study completion, an average of 8 weeks, change from baseline quality of life at 8 weeks.
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Evaluation of Biopsychosocial Status
大体时间：10 minutes, through study completion, an average of 8 weeks, change from baseline biopsychosocial status at 8 weeks.
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BETY-Biopsychosocial Questionnaire (BETY-BQ): Each of the questions in this scale, which consists of 30 different cognitive belief statements, is scored between 0-4.
The total score ranges from 0 to 120.
A high score indicates a poor biopsychosocial level.
It is a scale developed by Ünal et al.
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10 minutes, through study completion, an average of 8 weeks, change from baseline biopsychosocial status at 8 weeks.
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Evaluation of Depression and Anxiety Levels
大体时间：7 minutes, through study completion, an average of 8 weeks, change from baseline depression and anxiety levels at 8 weeks.
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This scale consisting of 14 questions, odd-numbered questions question anxiety and even questions question depression.
The options take values between 0-3, with a high score indicating a bad emotional state.
The cut-off values of the scale were determined as 10 for the anxiety subscale and 7 for the depression subscale.
The Turkish version study was done by Aydemir et al.
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7 minutes, through study completion, an average of 8 weeks, change from baseline depression and anxiety levels at 8 weeks.
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Evaluation of Physical Activity Level
大体时间：5 minutes, through study completion, an average of 8 weeks, change from baseline physical activity level at 8 weeks.
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International Physical Activity Questionnaire (IPAQ)-Short Form: There are eight versions of the questionnaire in total, but the short form "last 7 days" will be used in this study. The short form (7 questions) provides information about the time spent in walking, moderate-to-vigorous and vigorous activities. The time spent sitting is considered a separate question. It is classified as low, medium, and high level by calculating the activity level of the person in terms of METs according to the duration, frequency, and intensity level of the movement. The Turkish version study was done by Sağlam et al. |
5 minutes, through study completion, an average of 8 weeks, change from baseline physical activity level at 8 weeks.
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Evaluation of Kinesiophobia
大体时间：5 minutes, through study completion, an average of 8 weeks, change from baseline kinesiophobia at 8 weeks
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Tampa Kinesophobia Scale (TCS): It is a 17-question scale that evaluates injury avoidance and fear of movement, and Kori et al. developed by.
The Turkish version is from Tunca-Yılmaz et al.
Made by.
Its scoring is scored with "1 = Strongly disagree, 4 = Strongly agree".
The score is calculated by reversing items 4, 8, 12, and 16.
The total score is between 17 and 68.
It is understood that the higher the score, the higher the kinesophobia.
A total score of more than 37 is considered to be a high degree of kinesophobia.
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5 minutes, through study completion, an average of 8 weeks, change from baseline kinesiophobia at 8 weeks
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Evaluation of Illness Perception
大体时间：3 minutes, through study completion, an average of 8 weeks, change from baseline illness perception at 8 weeks.
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Brief Illness Perception Scale (BIPQ): In this scale, which consists of 9 questions, each question evaluates a component of the perception of illness. The first eight questions take values between 0-10. A high score indicates an increased level of perception of the disease as worrisome. The total score ranges from 0 to 80. The ninth question is an open-ended question that questions the patient's opinion about the possible causes of the disease. Turkish validity and reliability study was done by Karataş et al. |
3 minutes, through study completion, an average of 8 weeks, change from baseline illness perception at 8 weeks.
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Evaluation of Central Sensitization
大体时间：5 minutes, through study completion, an average of 8 weeks, change from baseline central sensitization at 8 weeks
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Central Sensitization Scale (CSS): It consists of 25 questions.
The symptoms associated with central sensitization are questioned.
Above 40 points is interpreted as an indicator of central sensitization.
Turkish validity and reliability study was conducted by Düzce et al.
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5 minutes, through study completion, an average of 8 weeks, change from baseline central sensitization at 8 weeks
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Spinal stabilization exercise的临床试验
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University of Maryland, BaltimoreNational Institute on Aging (NIA)完全的
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Ataturk Training and Research Hospital完全的
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Bnai Zion Medical Center未知