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临床试验/NCT06104774
NCT06104774招募中不适用

Vice Superintendent

China Medical University Hospital2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年10月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
2
主要终点
vital capacity (VC)

研究概览

简要总结

To explore the effect of a family-centered, eight-week, progressive sit-to-stand Tai Chi exercise on lung function and mental health in patients after thoracoscopic surgery_

详细描述

Lung cancer is the top death among cancers in Taiwan. The surgical excision of lung tissue is unable to regenerate new tissue after thoracoscopic lobectomy, resulting in decreased lung function and affecting health-related quality of life. 29% of female patients who received thoracic surgery tended to be anxious and depressed, and more than 60% of the family caregivers experienced mild to moderate caregiving burden and anxiety. Tai Chi exercise is a gentle exercise that can effectively enhance lung function. However, there is a lack of literature on the effects of Tai Chi exercise on lung function and mental health after thoracoscopic surgery.Methods: Exploratory sequential mixed methods study design will be used. The first phase will be a quasi-experimental study that will use purposive sampling to recruit thoracoscopic surgical patients and their family caregivers. It is estimated to enroll 60 pairs of patients and their family caregivers. The participants will be divided into experimental and control groups according to the sequential time of admission. The experimental group will receive Tai Chi exercise and routine treatment after the operation, and after discharge from the hospital, they will perform Tai Chi exercise three times a week, 50 minutes each time, for a total of eight weeks after discharge; the control group will receive conventional treatment. Repeated measures analysis of variance (repeated ANOVA) will be used for comparison between the experimental group and the control group and within the group; for other confounding factors, generalized estimating equations (GEE) will be used for analysis. In the second stage, after eight weeks of Tai Chi exercise, semi-structured interviews with about 10 patients and their caregivers will be conducted to collect their experiences and feelings related to the Tai Chi exercise. Qualitative data will be used to comprehend the quantitative data.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Supportive Care
盲法
Triple (Participant, 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

入选标准

  • Hospitalized to receive thoracoscopic lobectomy, wedge/partial resection, lobectomy, or sleeve resection.
  • American Society of Anesthesiologists (ASA) physiological status classification I-II (ASA, 2019).ASA Physical Status Class I: A healthy person who is healthy and does not smoke or drink.ASA physical status class II: People with mild chronic diseases but no substantial functional limitations.
  • Those who can walk on their own without any impairment in limb movement.
  • Able to communicate in Chinese or Taiwanese.

排除标准

  • Individuals requiring chemotherapy and radiation therapy for malignant tumors.
  • Those who have practiced Tai Chi, Qigong, external elixir exercises, or pulmonary exercises within the past year.
  • Anticipating hospitalization or surgical treatment within the next three months.
  • Individuals with musculoskeletal or peripheral vascular diseases.
  • Individuals with visual impairment, intellectual disabilities, or memory loss.

结局指标

主要结局

vital capacity (VC)

时间窗: admission day, discharge 1 day, 7 day after discharge, one month after discharge, two months after discharge

data will be collected through lung function test

forced expiratory volume in one second (FEV1)

时间窗: admission day, discharge 1 day, 7 day after discharge, one month after discharge, two months after discharge

data will be collected through lung function test

forced vital capacity (FVC)

时间窗: admission day, discharge 1 day, 7 day after discharge, one month after discharge, two months after discharge

data will be collected through lung function test

次要结局

  • Hospital anxiety and depression scale composite(Baseline (Before operation), immediately post-operation, discharged 1 day, one week after discharge, one month after discharge, two months after discharge)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hsin-Yuan Fang

Vice Superintendent

China Medical University Hospital

研究点 (2)

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