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

Vice Superintendent

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_

Study Overview

• Status: Not yet recruiting
• Conditions: Thoracic Neoplasms
• Intervention / Treatment: Behavioral: Tai Chi Exercise

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hsin-Yuan Fang, Ph.D; Phone Number: 12939 04-22052121; Email: fanghy@cmuh.org.tw

Study Locations

• Taiwan
  • North Dist.
    • Taichung, North Dist., Taiwan, 404327
      • China Medical University
      • Contact: Hsin-Yuan Fang, Ph.D; Phone Number: 12939 04-22052121; Email: fanghy@cmuh.org.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; conventional treatment
Experimental: Tai Chi group; After recruitment, participants will receive Tai Chi Exercise teaching. In the acupressure group, participants will receive acupressure treatment.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
vital capacity (VC)	data will be collected through lung function test	admission day, discharge 1 day, 7 day after discharge, one month after discharge, two months after discharge
forced vital capacity (FVC)	data will be collected through lung function test	admission day, discharge 1 day, 7 day after discharge, one month after discharge, two months after discharge
forced expiratory volume in one second (FEV1)	data will be collected through lung function test	admission day, discharge 1 day, 7 day after discharge, one month after discharge, two months after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital anxiety and depression scale composite	This scale measures the feelings of anxiety and stress that one has experienced in the past week. It has a total of 14 questions, including 7 questions each for the Anxiety Scale (HADS-A) and the Depression Scale (HADS-D). It is measured on a 4-point Likert scale. Score method (0-3), the total score of each item is 0-21 points, the higher the score measured by the scale, the higher the degree of anxiety and depression. The Cronbach's α coefficients of the internal consistency reliability of HADS-A and HADS-D are respectively 0.82-0.74, with high internal consistency.	Baseline (Before operation), immediately post-operation, discharged 1 day, one week after discharge, one month after discharge, two months after discharge

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Investigators: Principal Investigator: Hsing-Chi Hsu, Ph.D, HungKuang University, Taiwan; Principal Investigator: Kai-yu Tseng, Ph.D, Central Taiwan University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Estimated): October 20, 2023
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: October 26, 2023
• First Posted (Actual): October 27, 2023

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Mental Health; Sleep; Lung cancer; Lung function; thoracoscopic surgery; Tai Chi exercise; Family-Centered
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Thoracic Neoplasms
• Other Study ID Numbers: d17573

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No