Thoracic NeoplasmsNCT06104774
The Effects of a Family-Centered Tai Chi Exercise on Lung Function and Mental Health of Patients After Thoracoscopic Surgery
A study testing Tai Chi Exercise in people with Thoracic Neoplasms, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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_ Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thoracic Neoplasms
- What is being tested?
- Tai Chi Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Oct 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University
Taichung, North Dist., 404327
Hsin-Yuan Fang, Ph.D, 04-22052121 ext. 12939, fanghy@cmuh.org.tw
About this study
Official title: 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_
Read the 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.
- Conditions
- Thoracic Neoplasms
- Being tested
- Tai Chi Exercise
- Keywords
- Tai Chi exercise, Lung cancer, thoracoscopic surgery, Lung function, Mental Health, Sleep, Family-Centered
- Medical subject headings
- Thoracic Neoplasms, Lung Neoplasms, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Chi ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi group | Experimental | After recruitment, participants will receive Tai Chi Exercise teaching. In the acupressure group, participants will receive acupressure treatment. Receives: Behavioral: Tai Chi Exercise |
| Control group | No intervention | conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
vital capacity (VC)
data will be collected through lung function test
Measured: 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
Measured: 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
Measured: admission day, discharge 1 day, 7 day after discharge, one month after discharge, two months after discharge
Secondary outcomes (1)
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.
Measured: Baseline (Before operation), immediately post-operation, discharged 1 day, one week after discharge, one month after discharge, two months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start20 Oct 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic NeoplasmsStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsin-Yuan Fang, China Medical University Hospital
- Investigators
- Hsing-Chi Hsu, Ph.D, Principal investigator, HungKuang University, TaiwanKai-yu Tseng, Ph.D, Principal investigator, Central Taiwan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104774
- Sponsor's protocol ID
- d17573
- Status last verified
- Apr 2025
- First submitted
- 18 Oct 2023
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vice Superintendent
- ClinicalTrials.gov ID
- NCT06104774
- Acronym / sponsor ID
- d17573
- Conditions
- Thoracic Neoplasms
- Keywords
- Tai Chi exercise, Lung cancer, thoracoscopic surgery, Lung function, Mental Health, Sleep, Family-Centered
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tai Chi group | Experimental | Behavioral: Tai Chi ExerciseAfter recruitment, participants will receive Tai Chi Exercise teaching. In the acupressure group, participants will receive acupressure treatment. |
| Control group | No intervention | –conventional treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai Chi ExerciseThe 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. | Behavioural | Tai Chi group |
Primary outcome
vital capacity (VC)
Time frame: 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
forced vital capacity (FVC)
Time frame: 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
forced expiratory volume in one second (FEV1)
Time frame: 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
1 secondary outcome
Hospital anxiety and depression scale composite
Time frame: Baseline (Before operation), immediately post-operation, discharged 1 day, one week after discharge, one month after discharge, two months after discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hsing-Chi Hsu, Ph.D principal investigator
HungKuang University, Taiwan
Kai-yu Tseng, Ph.D principal investigator
Central Taiwan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi Exercise in people with Thoracic Neoplasms, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hsin-Yuan Fang, Ph.D (04-22052121 ext. 12939, fanghy@cmuh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vital capacity (VC) (time frame: admission day, discharge 1 day, 7 day after discharge, one month after discharge, two months after discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.