TELEREHABILITATION VERSUS CENTRE BASED PULMONARY REHABILITATION IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS: A RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- RV
研究概览
简要总结
This study will follow a prospective, randomized controlled trial design, recruiting 28 patients with Idiopathic Pulmonary Fibrosis (IPF) from Metro Centre for Respiratory Diseases, Metro Hospitals & Heart Institute in Noida, India. Participants will be randomly assigned to either the Tele-Rehabilitation (TR) group or the Centre-Based Pulmonary Rehabilitation (CBPR) group using computer-generated block randomization. Both groups will undergo a six-week rehabilitation program, with three supervised sessions per week. .
**Outcome Measures:**Pulmonary function Respiratory muscle strength ( Functional capacity . Quality of life (King’s Brief Interstitial Lung Disease - Dyspnea severity (Modified Medical Research Council
The intervention will include structured exercise training, breathing techniques, patient education, and psychosocial support. All sessions will be monitored for adherence and safety, with continuous tracking of oxygen saturation, heart rate, and perceived exertion levels. Post-intervention assessments will be conducted using the same baseline outcome measures to evaluate the effectiveness of TR compared to CBPR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •a) Participants must have a definitive diagnosis of idiopathic pulmonary fibrosis based on clinical evaluations, radiological assessments, and histopathological criteria via high-resolution computed tomography (HRCT), pulmonary function tests, following ATS/ERS guidelines and incorporating relevant diagnostic measures (Raghu et al., 2018).
- •b) Subjects must be at least 18 years of age or older.
- •c) Participants must be capable of completing a 6MWT/ISWT for functional assessments that indicate sufficient exercise tolerance.
- •d) Participants should exhibit no significant comorbid conditions that may hinder their involvement in the rehabilitation program, such as severe cardiac issues, uncontrolled diabetes, or recent surgical interventions.
- •e) Patients must possess the cognitive capacity to comprehend and actively engage in the rehabilitation program.
- •f) All participants must have the ability to provide written & oral informed consent.
排除标准
- •a) Patients experiencing an acute exacerbation of IPF or significant symptom worsening within the past 4 to 6 weeks.
- •b) Individuals with significant comorbid conditions that could impede participation in the rehabilitation program, including but not limited to severe cardiac diseases, uncontrolled diabetes, or recent major surgeries.
- •c) Individuals currently enrolled in other clinical trials or rehabilitation programs that may interfere with the outcomes of this study.
- •d) Conditions that could hinder the use of tele-rehabilitation, including lack of access to necessary technology (e.g., smartphone, computer, internet connection) or inability to navigate these technologies.
- •e) Showed unwillingness to follow the protocol, f) Unable to speak and/or understand Hindi/English.
结局指标
主要结局
RV
时间窗: At baseline and at 6 six weeks
TLC
时间窗: At baseline and at 6 six weeks
RV/TLC
时间窗: At baseline and at 6 six weeks
Forced Vital Capacity (FVC)
时间窗: At baseline and at 6 six weeks
Forced Expiratory Volume in One Second (FEV1)
时间窗: At baseline and at 6 six weeks
FEV1/FVC
时间窗: At baseline and at 6 six weeks
Diffusing Capacity for Carbon Monoxide (DLCO)
时间窗: At baseline and at 6 six weeks
次要结局
- NA(NA)
研究者
Adila Parveen
Jamia Milllia Islamia