Comparison of Postoperative Telerehabilitation and Unsupervised Home-Based Training in Older Adults With Lung Cancer: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Change From Baseline in VO2 Peak (Peak Oxygen Uptake, mL/kg/Min) on the CardioPulmonary Exercise Test(CPET) After 4 Weeks Intervention
研究概览
简要总结
The purpose of this study is to confirm the effectiveness of a mobile messenger-based home tele-rehabilitation protocol in patients who have undergone lung resection surgery.
By analyzing the difference from the existing postoperative pulmonary rehabilitation, the investigators would like to propose a new pulmonary tele-rehabilitation protocol.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A person who is suspected of lung cancer and is scheduled to undergo a thoracoscopic lung resection surgery.
- •men and women the age ≥65 years.
- •A person who understands the course of the clinical trial and signs the informed consent form.
排除标准
- •Patients whose activity is restricted due to other diseases (e.g. osteoarthritis, spinal disease, cerebral infarction, etc.)
- •Patients who cannot test bioimpedance analysis due to the insertion of artificial pacemakers and defibrillators
- •A person who has difficulty judging himself/herself due to dementia, etc
- •Those enrolled in other clinical trials
- •A person deemed inappropriate to participate in this clinical trial under the judgement of the investigator.
- •A person who cannot use mobile messenger
研究组 & 干预措施
Tele-rehabilitation group
The Tele-rehabilitation group performs 12 training sessions during four weeks. (3 sessions/week)
干预措施: Pulmonary Tele-Rehabilitation (Other)
Control group
The control group receives usual care with only one educational session.
干预措施: Control (Education) (Other)
结局指标
主要结局
Change From Baseline in VO2 Peak (Peak Oxygen Uptake, mL/kg/Min) on the CardioPulmonary Exercise Test(CPET) After 4 Weeks Intervention
时间窗: Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)
Cardiopulmonary exercise test (CPET) also referred to as a VO2 (oxygen consumption) test, is a specialized type of stress test or exercise test that measures participants exercise ability.
次要结局
- Ventilatory Efficiency (VE/VCO₂ Slope)(Immediately After Rehabilitation and at 4-Week Follow-Up)
- Maximal Inspiratory Pressure (MIP)(Immediately After Rehabilitation and at 4-Week Follow-Up)
- Skeletal Muscle Index (SMI)(Immediately After Rehabilitation and at 4-Week Follow-Up)
- Hospital Anxiety and Depression Scale (HADS)(Immediately After Rehabilitation and at 4-Week Follow-Up)
- EQ-5D (EuroQol-5 Dimension)(Immediately After Rehabilitation and at 4-Week Follow-Up)
- Grip Strength(Immediately After Rehabilitation and at 4-Week Follow-Up)
- Steps(Immediately After Rehabilitation and at 4-Week Follow-Up)
- Peak Expiratory Flow (PEF)(Immediately After Rehabilitation and at 4-Week Follow-Up)
- Forced Vital Capacity (FVC)(Immediately After Rehabilitation and at 4-Week Follow-Up)
- The Forced Expiratory Volume in 1 Second (FEV1)(Immediately After Rehabilitation and at 4-Week Follow-Up)
- Whole-Body Phase Angle(Immediately After Rehabilitation and at 4-Week Follow-Up)