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

Sponsor
China Medical University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06104774
Collaborator
(none)
200
1
2
21.4
9.4

Study Details

Study Description

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_

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Tai Chi Exercise
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Vice Superintendent
Anticipated Study Start Date :
Oct 20, 2023
Anticipated Primary Completion Date :
Jul 31, 2025
Anticipated Study Completion Date :
Jul 31, 2025

Arms and Interventions

Arm Intervention/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.

No Intervention: Control group

conventional treatment

Outcome Measures

Primary Outcome Measures

  1. vital capacity (VC) [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

  2. forced vital capacity (FVC) [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

  3. forced expiratory volume in one second (FEV1) [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

Secondary Outcome Measures

  1. 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]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 China Medical University Taichung North Dist. Taiwan 404327

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hsin-Yuan Fang, Vice Superintendent, China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT06104774
Other Study ID Numbers:
  • d17573
First Posted:
Oct 27, 2023
Last Update Posted:
Oct 27, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hsin-Yuan Fang, Vice Superintendent, China Medical University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 27, 2023