Effectiveness of a 12-week Telerehabilitation Training in Patients With Bronchiectasis: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 6-minute walk distance
研究概览
简要总结
Background: Home-based telerehabilitation (TR) has demonstrated benefits comparable to conventional rehabilitation in patients with chronic obstructive pulmonary disease, asthma, and pulmonary fibrosis. However, TR has not been thoroughly investigated in patients with bronchiectasis, despite evidence suggesting improvements in exercise capacity and quality of life.
Aims: To evaluate the effects of TR on functional capacity, quality of life, and inflammatory biomarkers, as well as its safety in patients with bronchiectasis.
Study design: Single-center randomized controlled trial with a parallel-group design.
Methods: Patients diagnosed with bronchiectasis will be recruited from the Surgical Medical Unit for Respiratory Diseases at Virgen del Rocío University Hospital. Participants will be randomly assigned to one of two groups: a control group receiving usual care, and a TR group undergoing supervised physical training for 12 weeks, three times per week. Outcome measures will include the 6-minute walk test, quality-of-life questionnaires, pulmonary function tests, symptom assessment, and adverse event recording, as well as sputum microbiology and analysis of inflammatory biomarkers. Assessments will be conducted at baseline and at the end of the intervention.
Expected results: A 12-week TR program is expected to significantly improve exercise capacity and quality of life in the intervention group. Additionally, this study may contribute to the development of future clinical guidelines regarding the use of TR in patients with bronchiectasis.
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 (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bronchiectasis diagnosed by high resolution computed tomography (HRCT) of the chest.
- •Clinically stable patients (without hospitalizations, infection or changes in pharmacological treatment in the last month of the study beginning).
- •Both gender
- •Non smokers.
- •Internet connection available.
排除标准
- •Inability to give informed consent to participate
- •Less of 18 years
- •With other lung related diseases (asthma, COPD and cystic fibrosis)
- •Decompensated cardiovascular and metabolic diseases, neuromuscular or musculoskeletal that impede the realization of the protocol.
- •Mental disorders that prevent the adequate participation in the tele-rehabilitation program.
- •Simultaneous participation in another clinical trial.
研究组 & 干预措施
Usual care group
Standard care for exacerbation and follow-up without rehabilitation.
Exercise group
Telerehabilitation: 12 weeks of supervised exercise interventions.
干预措施: telerehabilitation (Other)
结局指标
主要结局
6-minute walk distance
时间窗: Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program.
Patients walk through a 30-meter corridor faster than they can for 6 minutes
次要结局
- The quality of life(Baseline, after 12 weeks of telerehabilitation program and at 3 and 6 months after completing the telerehabilitation program.)
- Pulmonary function tests(Baseline and after 12 weeks of telerehabilitation program.)
- Respiratory Muscle Strength(Baseline and after 12 weeks of telerehabilitation program.)
- Exahled Nitric Oxide Fraction (FeNO)(Baseline and after 12 weeks of telerehabilitation program.)
- Sputum microbiology(Baseline, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program.)
- Biological markers of Biological markers of inflammation(Baseline and after 12 weeks of telerehabilitation program.)
- Dyspnoea(Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program.)
- Bronchiectasis severity(Baseline and after 12 weeks of telerehabilitation program.)
- Change from baseline in respiratory symptoms and adverse events.(Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program.)
- Blood pressure(Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program.)
- Heart rate(Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program.)
- Oxygen saturation (SpO2)(Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program.)
- Exacerbation(Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program.)
- Telerehabilitation adherence(Baseline, week 6, after 12 weeks of telerehabilitation program, and at 3 and 6 months after completing the telerehabilitation program.)
研究者
Ana Ortega Moral
PhD Student
Hospitales Universitarios Virgen del Rocío