Comparison of Body Awareness, Respiratory Muscle Strength, Kinesiophobia, Central Sensitization, Functional Status and Sleep Quality in Sedentary and Non-Sedentary Fibromyalgia Individuals
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- International Physical Activity Questionnaire (IPAQ) - Short Form
研究概览
简要总结
Fibromyalgia syndrome (FMS) is a chronic condition characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, and functional limitations. Pain, fatigue, and fear of movement often lead individuals with FMS to adopt sedentary behaviors, which may further exacerbate symptoms and reduce physical capacity. Factors such as impaired body awareness, reduced respiratory muscle strength, kinesiophobia, central sensitization, poor functional status, and sleep disturbances play an important role in disease severity and quality of life in individuals with FMS.
Although physical inactivity is common in fibromyalgia, limited evidence exists regarding the differences in these multidimensional clinical parameters between sedentary and non-sedentary individuals with FMS. Therefore, the aim of this study is to compare body awareness, respiratory muscle strength, kinesiophobia, central sensitization, functional status, and sleep quality between sedentary and non-sedentary individuals diagnosed with fibromyalgia syndrome. The findings of this study may contribute to a better understanding of the impact of sedentary behavior on clinical outcomes in fibromyalgia and help guide more comprehensive and individualized rehabilitation approaches.
详细描述
Fibromyalgia syndrome (FMS) is a chronic pain condition characterized by widespread musculoskeletal pain, sleep disturbances, and fatigue. Along with other symptoms such as joint stiffness, depression, anxiety, and cognitive dysfunction, FMS restricts daily life, negatively affects physical activity, and reduces individuals' ability to cope with daily demands. Moreover, FMS can lead to reduced productivity, work-related disability, and increased healthcare costs. As a result, patients experience limitations in activities of daily living and overall functional capacity. As a chronic pain condition, FMS may contribute to impaired functional capacity through the adoption of sedentary behaviors. Pain and fatigue associated with FMS often lead to physical inactivity, resulting in muscle deconditioning and, consequently, increased pain and fatigue, creating a vicious cycle. FMS affects approximately 2-6% of the global population and is the second most common rheumatologic disorder after osteoarthritis. However, the pathogenesis of the disease has not yet been fully elucidated.
Body awareness refers to the ability to perceive bodily sensations, movements, and the relationship between the body and its environment. In individuals with FMS, body awareness is often impaired, leading to difficulties in recognizing and interpreting bodily signals related to pain, fatigue, and stress. This impairment in body awareness may exacerbate symptoms and hinder the implementation of effective coping strategies. Enhanced body awareness allows patients to identify factors that trigger pain and to develop more effective coping mechanisms. Previous studies have demonstrated that therapeutic approaches focusing on body awareness are beneficial in reducing pain levels and improving movement quality in individuals with FMS.
Body awareness is also associated with psychological factors commonly observed in individuals with FMS, such as anxiety and depression. It has been reported that as body awareness increases, individuals with FMS are better able to analyze their emotional responses to their physical condition, which may help reduce anxiety levels. Furthermore, studies have shown that interventions aimed at improving body awareness result in positive changes in psychological functioning, including reductions in anxiety and depression, in individuals with FMS.
Compared with healthy individuals, people with FMS exhibit lower respiratory muscle strength and endurance. Studies in the literature indicate that maximal inspiratory pressure and maximal expiratory pressure-important indicators of respiratory muscle performance-are reduced in individuals with FMS. This reduction can cause difficulty in breathing during physical activities, contributing to a persistent cycle of fatigue and weakness. A correlation has been observed between respiratory muscle strength and the severity of FMS symptoms. Previous studies have demonstrated that reduced inspiratory muscle strength is associated with a higher number of tender points, greater fatigue severity, and decreased thoracic mobility.
Participation in physical activities among individuals with FMS is often limited due to pain and fatigue, and the resulting increase in physical inactivity further reduces respiratory muscle strength. Interventions aimed at improving respiratory muscle strength have been shown to enhance exercise tolerance, physical function, and quality of life, while also reducing pain and fatigue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
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
- •Sedentary Fibromyalgia Participants
- •Physical activity level below 600 MET-min/week according to the International Physical Activity Questionnaire (IPAQ)
- •Diagnosis of fibromyalgia according to the 2016 ACR criteria
- •Age between 18 and 65 years
- •Ability to understand and respond to study assessments
排除标准
- •Sedentary Fibromyalgia Participants
- •Conditions posing risk during assessments, including unstable angina, decompensated heart failure, or myocardial infarction within the past month
- •Uncontrolled diabetes, hypertension >180/110 mmHg, and/or severe neuropathy
- •Diagnosed severe cognitive impairment
- •Pregnancy or suspected pregnancy Inclusion Criteria - Non-Sedentary Fibromyalgia Participants
- •Physical activity level above 600 MET-min/week according to the IPAQ
- •Diagnosis of fibromyalgia according to the 2016 ACR criteria
- •Age between 18 and 65 years
- •Ability to understand and respond to study assessments
- •Exclusion Criteria - Non-Sedentary Fibromyalgia Participants
- •Conditions posing risk during assessments, including unstable angina, decompensated heart failure, or myocardial infarction within the past month
- •Uncontrolled diabetes, hypertension >180/110 mmHg, and/or severe neuropathy
- •Diagnosed severe cognitive impairment
- •Pregnancy or suspected pregnancy
研究组 & 干预措施
Sedentary Fibromyalgia Group
Individuals diagnosed with fibromyalgia syndrome who meet the criteria for sedentary behavior.
干预措施: Assessment Only (Other)
Non-Sedentary Fibromyalgia Group
Individuals diagnosed with fibromyalgia syndrome who do not meet the criteria for sedentary behavior.
干预措施: Assessment Only (Other)
结局指标
主要结局
International Physical Activity Questionnaire (IPAQ) - Short Form
时间窗: Baseline
The International Physical Activity Questionnaire (IPAQ) is commonly used to assess physical activity. In this study, the 7-item short form of the IPAQ will be used. The questionnaire evaluates the number of days and duration over the past 7 days in which participants performed vigorous physical activity, moderate physical activity, and walking for at least 10 minutes per session. Total physical activity is calculated by multiplying the duration and frequency of each activity by its MET value: 8 MET for vigorous, 4 MET for moderate, and 3.3 MET for walking. Sedentary time is not included in the calculation. The weekly MET score is summed across all activities: \<600 MET-min/week is considered inactive, 601-3,000 MET-min/week moderately active, and \>3,000 MET-min/week active
Mindful Attention Awareness Scale (MAAS)
时间窗: Baseline
The MAAS is a 15-item scale measuring the general tendency to be aware of and attentive to present-moment experiences. The scale is unidimensional, yielding a single total score, where higher scores indicate greater mindfulness. Items are rated on a 6-point Likert scale from 1 (almost always) to 6 (almost never).
Postural Awareness Scale (PAS)
时间窗: Baseline
The Postural Awareness Scale evaluates individuals' postural awareness and efforts to regulate their posture. It consists of two factors and a total of 11 items. Total scores range from 11 to 77, with higher scores indicating better postural awareness.
Fibromyalgia Impact Questionnaire (FIQ)
时间窗: Baseline
The Fibromyalgia Impact Questionnaire (FIQ) assesses functional status in fibromyalgia patients. The FIQ evaluates 10 domains: physical function, feeling well, work difficulty, work missed, pain, fatigue, morning tiredness, stiffness, anxiety, and depression. Excluding the "feeling well" domain, lower scores indicate better function. The questionnaire is patient-reported and takes approximately 5 minutes to complete, with a total score of 100. Physical Function Subscale: 11 questions scored 0-3, summed and averaged, then multiplied by 3.33 (range 0-33).Feeling Well Subscale: Reverse-scored, average multiplied by 1.43 (range 0-7).Work Missed Subscale: Directly scored, multiplied by 1.43. Other domains: Scored 0-10 per item; higher scores indicate greater impairment. All scores are summed to obtain a total FIQ score.
Tampa Scale of Kinesiophobia (TSK)
时间窗: Baseline
The Tampa Scale for Kinesiophobia (TSK) was originally developed to assess fear of movement. The scale has 17 items, rated on a 4-point Likert scale (1 = strongly disagree to 4 = strongly agree). Items 4, 8, 12, and 16 are reverse-scored. Higher total scores indicate higher kinesiophobia.
Central Sensitization Inventory (CSI)
时间窗: Baseline
The CSI assesses symptoms related to central sensitization in individuals with chronic pain. It consists of two parts: Part A evaluates 25 somatic and psychosocial symptoms commonly associated with central sensitization; Part B identifies medical conditions known to be related to central sensitization (not scored). Total scores are out of 100, with ≥40 indicating the presence of central sensitization.
Pittsburgh Sleep Quality Index (PSQI)
时间窗: Baseline
The PSQI is a 24-item self-report questionnaire evaluating sleep quality and disturbances. The first 19 items are self-rated, and the remaining 5 are answered by a partner or roommate but are not included in scoring. Higher total scores indicate worse sleep quality. Seven subcomponents are scored 0-3: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Total scores range from 0-21; scores ≥5 indicate poor sleep quality
Respiratory Muscle Strength Assessment
时间窗: Baseline
Respiratory muscle strength will be measured using the Cosmed Pony FX spirometer. Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) will be assessed. MIP: Participant performs maximal expiration in a seated position, followed by maximal inspiration against a closed airway for 1-3 seconds. MEP: Participant performs maximal inspiration, followed by maximal expiration against a closed airway for 1-3 seconds. Three measurements will be taken, and the best value will be recorded. Age- and sex-specific reference values will be used.
次要结局
未报告次要终点
研究者
Betül Taşpınar
Prof.Dr.
Izmir Democracy University