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Trial Title:
The Effects of a Family-Centered Tai Chi Exercise on Lung Function and Mental Health of Patients After Thoracoscopic Surgery
NCT ID:
NCT06104774
Condition:
Thoracic Neoplasms
Conditions: Official terms:
Thoracic Neoplasms
Conditions: Keywords:
Tai Chi exercise
Lung cancer
thoracoscopic surgery
Lung function
Mental Health
Sleep
Family-Centered
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Supportive Care
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Tai Chi Exercise
Description:
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.
Arm group label:
Tai Chi group
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
China Medical University
Address:
City:
Taichung
Zip:
404327
Country:
Taiwan
Contact:
Last name:
Hsin-Yuan Fang, Ph.D
Phone:
04-22052121
Phone ext:
12939
Email:
fanghy@cmuh.org.tw
Start date:
October 20, 2023
Completion date:
July 31, 2025
Lead sponsor:
Agency:
China Medical University Hospital
Agency class:
Other
Source:
China Medical University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06104774