The Effects of a Family-Centered Tai Chi Exercise on Lung Function and Mental Health of Patients After Thoracoscopic Surgery

Официальное название

Vice Superintendent

Обзор

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\_

Подробное описание

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.

Вмешательства

• Поведенческое Tai Chi Exercise
  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.

Первичные конечные точки

• vital capacity (VC) [Срок оценки: admission day, discharge 1 day, 7 day after discharge, one month after discharge, two months after discharge]
• forced vital capacity (FVC) [Срок оценки: admission day, discharge 1 day, 7 day after discharge, one month after discharge, two months after discharge]
• forced expiratory volume in one second (FEV1) [Срок оценки: admission day, discharge 1 day, 7 day after discharge, one month after discharge, two months after discharge]

Вторичные конечные точки (1)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Тройное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Тайвань · 1 центр

• China Medical University — Taichung

Идентификаторы

NCT: NCT06104774 · d17573

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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