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Clinical Trials/NCT06104774
NCT06104774RecruitingNot Applicable

Vice Superintendent

China Medical University Hospital1 site in 1 country200 target enrollmentStarted: October 20, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
200
Locations
1
Primary Endpoint
vital capacity (VC)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Sequential
Primary Purpose
Supportive Care
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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.

Arms & Interventions

Tai Chi group

Experimental

After recruitment, participants will receive Tai Chi Exercise teaching. In the acupressure group, participants will receive acupressure treatment.

Intervention: Tai Chi Exercise (Behavioral)

Control group

No Intervention

conventional treatment

Outcomes

Primary Outcomes

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 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

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

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hsin-Yuan Fang

Vice Superintendent

China Medical University Hospital

Study Sites (1)

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