Respiratory Function, Functional Capacity, Physical Activity, and Fatigue in Patients With Systemic Lupus Erythematosus: A Cross-Sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Forced Vital Capacity (FVC)
研究概览
简要总结
Increasing awareness of possible pulmonary involvement in patients with systemic lupus erythematosus (SLE) will enable earlier diagnosis of the disease and minimize damage accumulation. According to our research, no study has been found that examines respiratory functions in detail in SLE patients and investigates their relationship with functional capacity, physical activity, and fatigue levels. Our primary aim is to compare respiratory functions, functional capacity, physical activity, and fatigue levels between patients with SLE and healthy controls. Our secondary aim is to investigate the relationship between respiratory functions with functional capacity, physical activity levels, and fatigue in SLE patients.
详细描述
Systemic lupus erythematosus (SLE) is a chronic, inflammatory, autoimmune disease characterized by multisystem involvement. SLE can affect any organ or tissue, including the skin, joints, kidneys, central and peripheral nervous systems, lungs, and heart. Approximately 50% of patients with SLE may experience pulmonary involvement during the course of their disease. The most commonly reported manifestations in patients with SLE are pleurisy, diffuse alveolar hemorrhage, shrinking lung syndrome, interstitial lung disease, and pulmonary arterial hypertension.
Although estimates exist, the exact prevalence of pulmonary disease is unknown, and study findings have varied. In this context, our aim is to compare respiratory function, functional capacity, physical activity, and fatigue levels in patients with SLE with those in healthy controls. Our secondary aim is to investigate the relationship between respiratory function and functional capacity, physical activity level, and fatigue in patients with SLE.
Pulmonary function of the patients will be evaluated using pulmonary function tests. The level of physical activity of the participants will be assessed using the Global Physical Activity Questionnaire. Functional capacity will be evaluated with the 6-Minute Walk Test. Fatigue will be assessed using the Fatigue Severity Scale. Statistical analyses of the data obtained from the study will be performed using the Statistical Package for Social Sciences (SPSS) software.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- 是
入选标准
- •Patients who have been followed with a diagnosis of systemic lupus erythematosus for at least 1 year
- •Able to ambulate independently
- •No cognitive or mental impairment
- •Willing to participate in the study
排除标准
- •Presence of major musculoskeletal disease affecting the lower extremities
- •Presence of severe disease affecting the cardiovascular system
- •Being pregnant
- •Having a diagnosis of restrictive/interstitial lung disease due to the underlying condition
研究组 & 干预措施
Individuals with systemic lupus erythematosus
Individuals diagnosed with systemic lupus erythematosus according to the American College of Rheumatology classification criteria. Participants will be adults aged 18-65 years.
Healthy individuals
Age- and sex-matched healthy participants without any medical conditions (including neurological, genetic, or psychiatric disorders) that would prevent them from completing the tests.
结局指标
主要结局
Forced Vital Capacity (FVC)
时间窗: Time Frame: Baseline (day of enrollment) assessment
The pulmonary function test will be performed using the COSMED Pony FX device in accordance with the American Thoracic Society and European Respiratory Society guidelines.
Forced Expiratory Volume (FEV1)
时间窗: Baseline (day of enrollment) assessment
The pulmonary function test will be performed using the COSMED Pony FX device in accordance with the American Thoracic Society and European Respiratory Society guidelines.
Tiffeneau Index (FEV1/FVC)
时间窗: Baseline (day of enrollment) assessment
The pulmonary function test will be performed using the COSMED Pony FX device in accordance with the American Thoracic Society and European Respiratory Society guidelines.
Peak Expiratory Flow (PEF)
时间窗: Baseline (day of enrollment) assessment
The pulmonary function test will be performed using the COSMED Pony FX device in accordance with the American Thoracic Society and European Respiratory Society guidelines.
Functional Capacity
时间窗: Time Frame: Baseline (day of enrollment) assessment
Functional capacity is assessed using the 6-Minute Walk Test according to the criteria of the American Thoracic Society. Participants are instructed to walk as fast as possible, but without running, at their own pace along a 30-meter flat corridor for 6 minutes. The distance covered is recorded in meters.
Physical Activity Level
时间窗: Baseline (day of enrollment) assessment
The participants' physical activity status is assessed using the Global Physical Activity Questionnaire. The questionnaire consists of 16 questions. In the work and leisure activity sections, vigorous and moderate physical activities are assessed, while in the transportation section, moderate physical activities are assessed. In addition, there is an extra question for sedentary time. In each section, one yes/no question is followed by open-ended questions on the number of days per week and the duration per day. As a result of the questionnaire, the total weekly MET-minutes of physical activity are calculated. Moderate-intensity physical activities correspond to 4 MET/min, and vigorous-intensity physical activities correspond to 8 MET/min. Weekly total MET-minutes are calculated by multiplying with these coefficients.
次要结局
- Fatigue Level(Baseline (day of enrollment) assessment)
研究者
Melis Usul
Specialist Physiotherapist
Istanbul Kent University