Efficacy of Digitally Assisted Behavioral Physical Activity Intervention in Fibromyalgia Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change from Baseline Step Counts at 2 months
研究概览
简要总结
Digital health interventions have the potential to address physical inactivity as they are accessible to a large part of the population and can be delivered with high efficiency at a low cost. By enabling patient education, support for self-management, motivation, follow-up, feedback and communication, it can prevent, cure or treat many chronic conditions. These features can increase patient motivation and encourage compliance with home exercises and physical activity . Digital behavior change interventions use digital technologies (such as websites, mobile apps, Short Message Service or wearable devices) to promote and maintain health and have the potential to overcome many barriers compared to in-person programs by providing cost-effective, effective, and accessible information.
No study has been found in Turkey examining digital interventions or walking programs that include behavior change techniques to increase physical activity in patients with fibromyalgia syndrome. Considering environmental, cultural and economic factors in this patient group in our society, the investigators think that walking, which the investigators think is the most appropriate physical activity method in terms of cost, accessibility and equipment, should be a permanent behavior. The use of technology to increase physical activity in the era of digitalization is important in terms of addressing the increasing inactivity during the Covid19 pandemic period.
The aim of this study is to estimate the effect of digital assisted physical activity intervention combined with patient education compared to patient education alone on physical activity level, functional capacity, quality of life, sleep quality, pain, fatigue, and perspective on exercise of adults with Fibromyalgia Syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Being between the ages of 18-65
- •Having a female gender
- •Reporting at least 40 mm in weekly pain intensity from the VAS scored between 0-100 with 'no pain' and 'worst possible pain'
- •Using a fixed dose of medication for at least the past 6 months
- •Being in the "Inactive" group according to the International Physical Activity Survey (not participating in physical activity to meet the physical activity recommendations of the guides)
- •Using / agreeing to use WhatsApp application
排除标准
- •Having another disease that affects the physical condition
- •Cognitive inability to cooperate
- •Being pregnant
- •Inability to understand or speak Turkish
- •Concurrent autoimmune or inflammatory disease,
- •Diseases affecting the central nervous system (eg multiple sclerosis, Parkinson's disease),
- •Serious psychiatric conditions that prevent participation (eg, psychotic disorders).
- •Participation in a rehabilitation program in the past year,
- •Exercising regularly for 6 months
结局指标
主要结局
Change from Baseline Step Counts at 2 months
时间窗: At the baseline and 2 months later
The pedometer is an inexpensive, easy-to-use instrument designed to measure the number of steps and walking distance, providing objective measurement. It is usually attached to the lumbar region and includes a lever arm connected to a horizontal spring that bounces off with the vertical acceleration of the hips during walking (up-down motion during cruising). Pedometers designed to detect vertical movement logically determine the number of steps. The output of the device is easily understood as the number of movements representing a step. The pedometer (pedometer) is an easy-to-use device that can be easily carried by people and can approximate the number of steps, the distance walked and the calories consumed.
Change from Baseline Physical Activity Level at 2 months
时间窗: At the baseline and 2 months later
The purpose of the questionnaire is to obtain data on health-related physical activity. We used the short self-administered version in the present study. The short form International Physical Activity Questionnaire (IPAQ) is a 9-item scale, assessing the amount of minutes spent in vigorous and moderate intense activity and walking during the last 7 days. Also the amount of minutes spending sitting on week days in the past 7 days is assessed. For all categories patients have to define on how many days and how many minutes they spent at a specific activity category. For all categories, the amount of Metabolic Equivalents (METs)-minutes is calculated by multiplying the amount of minutes with 8 (vigorous), 4 (moderate), 3.3 (walking), or 1.3 (sitting). Besides these four subscores, a total score is calculated by counting the METs-minutes of the first 3 categories together.
次要结局
- Activity Diary(At the baseline and 2 months later)
- Change from Baseline Pain at 2 months(At the baseline and 2 months later)
- Change from Baseline Physical Activity Perception at 2 months(At the baseline and 2 months later)
- Change from Baseline Physical Activity Awareness at 2 months(At the baseline and 2 months later)
- Change from Baseline Functional Capacity at 2 months(At the baseline and 2 months later)
- Change from Baseline Quality of Life at 2 months(At the baseline and 2 months later)
- Change from Baseline Sleep Quality at 2 months(At the baseline and 2 months later)
- Change from Baseline Fatigue at 2 months(At the baseline and 2 months later)
研究者
Nimet Sermenli
Research Assistant
Marmara University