The Effect of Exercise Training on Quality of Life and Disease Progression in Fibrosing Interstitial Lung Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Saint George Quality of life questionnaire
研究概览
简要总结
In this study, the progression of the disease and changes in quality of life will be examined over a 1-year follow-up period in groups of patients with Fibrosing Interstitial Lung Disease who either participated in or did not participate in a pulmonary rehabilitation program. After the initial evaluation, the patients will be randomized into two groups: one serving as the control group and the other as the pulmonary rehabilitation exercise group.
详细描述
Patients diagnosed with fibrosing lung disease by a pulmonology specialist at Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital will be included in the study. Those meeting the inclusion criteria will be randomized into two groups: the Exercise Group (EGr) and the Control Group (CGr). After the initial evaluation, patients will be assessed at 3, 6, and 12 months. They will be called back to the hospital for follow-up evaluations. In addition to standard medical treatment, the EGr will undergo an exercise program. The initial exercise training will be conducted in the hospital, followed by online exercise sessions via video conferencing three times a week during the first week. From the second week onwards, they will be asked to perform their exercises at home three times a week using provided exercise videos and will be monitored for one year. Compliance with the exercise regimen will be assessed through a weekly survey shared in a WhatsApp group established for the exercise group patients. Patients in the CGr will receive an information brochure containing medical treatment and physical activity recommendations
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18-75 years
- •Diagnosed with fibrosing interstitial lung disease according to the clinical diagnostic criteria of the American Thoracic Society and European Respiratory Society (ATS-ERS)
- •Presence of dyspnea on exertion
- •Stable clinical condition at the time of inclusion without infection or exacerbation in the previous 4 weeks
- •Proficiency in using a smartphone
排除标准
- •Severe comorbid diseases, unstable coronary artery disease, collagen vascular diseases, or requiring high-flow oxygen therapy (> 3-4 L/min)
- •History of exertional syncope or any comorbidity that prevents exercise training (such as severe orthopedic or neurological deficits or unstable heart disease)
- •Participation in a pulmonary rehabilitation program within the last 12 months
结局指标
主要结局
Saint George Quality of life questionnaire
时间窗: Baseline, at 3rd, 6th and 12th months after the intervention
Saint George Respiratory Questionaire (SGRQ) score: The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).
Peripheral oxygen saturation
时间窗: Baseline, at 3rd, 6th and 12th months after the intervention
Peripheral oxygen saturation (SpO2) will be measured to assess the oxygen level in the blood. This non-invasive test provides an indication of how well oxygen is being transported to the extremities of the body, which is essential for evaluating respiratory function.
Forced vital capacity
时间窗: Baseline, at 3rd, 6th and 12th months after the intervention
It will perform by using the Pony Fx spirometry device, and according to the American Thoracic Society (ATS) guidelines.
Diffusing Capacity of the Lungs for Carbon Monoxide
时间窗: Baseline, at 3rd, 6th and 12th months after the intervention
Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) measurement will be conducted as part of the study to assess the lung function of participants. This test evaluates how well gases such as oxygen are transferred from the lungs to the blood.
次要结局
- Peripheral muscle strength(Baseline, at 3rd, 6th and 12th months after the intervention)
- Leicester cough questionnaire(Baseline, at 3rd, 6th and 12th months after the intervention)
- Six minute walking test(Baseline, at 3rd, 6th and 12th months after the intervention)
- Modified Medical Research Council Dyspnea Score(Baseline, at 3rd, 6th and 12th months after the intervention)
研究者
esra pehlivan
Principal Investigator
Istanbul Medipol University Hospital