Clinical Outcomes of Asynchronous Telerehabilitation Are Equivalent to Synchronous Telerehabilitation in Patients With Fibromyalgia: a Randomized Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Visual Analog Scale
研究概览
简要总结
Sixty-six FMS patients received the same exercise program for 8 weeks and divided, synchronous (n: 33), asynchronous (n: 33). Pain (Visual analog Scale, VAS), functional limitations and disabilities (Revised Fibromyalgia Impact Questionnaire, FEA), health-related quality of life (HRQol; Short Form-12, SF 12), catastrophizing (pain catastrophizing scale, PCS), anxiety and depression (Hospital Anxiety and Depression Scale, HAD), functional capacity (6-minute walking test, 6MWT), muscle strength (Arm curl test) joint position sense (Laser Cursor Assisted Angle Repetition Test, LI-RATT) were assessed at baseline, mid-treatment (week 4), end of treatment (week 8), and eight weeks after treatment (week 16).
详细描述
Materials and methods
A randomized clinical study. Sixty-six FMS patients received the same exercise program for 8 weeks and divided, synchronous (n: 33), asynchronous (n: 33). Pain (Visual analog Scale, VAS), functional limitations and disabilities (Revised Fibromyalgia Impact Questionnaire, FEA), health-related quality of life (HRQol; Short Form-12, SF 12), catastrophizing (pain catastrophizing scale, PCS), anxiety and depression (Hospital Anxiety and Depression Scale, HAD), functional capacity (6-minute walking test, 6MWT), muscle strength (Arm curl test) joint position sense (Laser Cursor Assisted Angle Repetition Test, LI-RATT) were assessed at baseline, mid-treatment (week 4), end of treatment (week 8), and eight weeks after treatment (week 16).
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)
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
- •Diagnosed with FMS by the physician in accordance with ACR 2016 criteria,
- •Having independent mobility,
- •Not having advanced vision and hearing loss,
- •Minimum literacy, participating voluntarily, making video calls, Internet and smartphone access
排除标准
- •Have a rheumatic disease with more prominent symptoms than FMS,
- •Have an active infection,
- •Have a surgical operation in the last three months,
- •Have an uncontrollable chronic disease,
- •Have another musculoskeletal disorder
研究组 & 干预措施
Synchronous Exercise Group
Synchronous telerehabilitation was performed via videoconference. Patients were taken to video conference calls accompanied by a researcher and supervisor. Participants were to perform their exercises simultaneously under the guidance of the researcher. Participants were taken to video conference calls in groups of 5 with similar functional levels. Each session lasts an average of 45 minutes. It was last. The start and end date of the exercise program, the number of repetitions for each exercise, the number of sets, daily repetitions, rest time between sets and the order of the exercises were determined by the researcher.
干预措施: Exercise Program (Other)
Asynchronous Exercise Group
Asynchronous telerehabilitation was carried out through the mobile application. Researchers created a record for each participant in the mobile application with the personal information of the participants. Participants were logged in to the application with an account address and password created for them. The mobile application was supervised and followed by a researcher. The principal researcher prepared an exercise program specifically for each participant. He sent the exercise program he had prepared to the relevant participants through the application. In the mobile application, all exercises are explained in video and writing.
干预措施: Exercise Program (Other)
结局指标
主要结局
Visual Analog Scale
时间窗: at baseline at mid-treatment (week 4), at the end of treatment (week 8), and eight weeks after treatment (week 16)
A visual analog scale was used to evaluate the patient's pain. This scale is used to quantify pain intensity that cannot be measured numerically. Numbers are written on the two ends of a 10 cm line. The patient is asked to indicate on this line where the pain condition is appropriate during rest by drawing a line, putting a dot or pointing. For pain intensity, according to the scale, "no pain" will be rated as 0 points and "worst pain imaginable" as 10 points. The ranges for pain intensity were determined as \<3 Mild pain, 3-6 moderate pain, 6 and above severe pain.
次要结局
- Laser Cursor Assisted Angle Repetition Test (LI-RATT)(at baseline at mid-treatment (week 4), at the end of treatment (week 8), and eight weeks after treatment (week 16))
- Revised Fibromyalgia Impact Questionnaire(at baseline at mid-treatment (week 4), at the end of treatment (week 8), and eight weeks after treatment (week 16))
- Pain Catastrophizing Scale(at baseline at mid-treatment (week 4), at the end of treatment (week 8), and eight weeks after treatment (week 16))
- Hospital Anxiety and Depression Scale(at baseline at mid-treatment (week 4), at the end of treatment (week 8), and eight weeks after treatment (week 16))
- 6 Minute Walk Test(at baseline at mid-treatment (week 4), at the end of treatment (week 8), and eight weeks after treatment (week 16))
- Arm Curl Test(at baseline at mid-treatment (week 4), at the end of treatment (week 8), and eight weeks after treatment (week 16))
- Short Form - 12(at baseline at mid-treatment (week 4), at the end of treatment (week 8), and eight weeks after treatment (week 16))
研究者
Eren Timurtas
Assoc. Prof.
Marmara University