Clinical trial NCT06104774: The Effects of a Family-Centered Tai Chi Exercise on Lung Function and Mental Health of Patients After Thoracoscopic Surgery
Official title: Vice Superintendent
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thoracic Neoplasms
Keywords: Tai Chi exercise
Lung cancer
thoracoscopic surgery
Lung function
Mental Health
Sleep
Family-Centered
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2023-10-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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_

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Hospitalized to receive thoracoscopic lobectomy, wedge/partial resection, lobectomy, or sleeve resection.
2. 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.
3. Those who can walk on their own without any impairment in limb movement.
4. Able to communicate in Chinese or Taiwanese.

Exclusion Criteria:

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

Primary outcomes:
measure: vital capacity (VC)
timeFrame: admission day, discharge 1 day, 7 day after discharge, one month after discharge, two months after discharge
measure: forced vital capacity (FVC)
timeFrame: admission day, discharge 1 day, 7 day after discharge, one month after discharge, two months after discharge
measure: forced expiratory volume in one second (FEV1)
timeFrame: admission day, discharge 1 day, 7 day after discharge, one month after discharge, two months after discharge
Secondary outcomes:
measure: Hospital anxiety and depression scale composite
timeFrame: Baseline (Before operation), immediately post-operation, discharged 1 day, one week after discharge, one month after discharge, two months after discharge
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University
state: North Dist.
Study officials:
affiliation: HungKuang University, Taiwan
name: Hsing-Chi Hsu, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Taiwan University of Science and Technology
name: Kai-yu Tseng, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: