Clinical trial NCT03420885: Effects of Ba Duan Jin for Patients With Pulmonary Nodules
Official title: Ba Duan Jin for Patients With Pulmonary Nodules on Physical Condition, Psychological Condition and Quality of Life: A Pilot Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Nodules
Keywords: Ba Duan Jin
Pulmonary Nodules
Clinical Intervention
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Yueyang Integrated Medicine Hospital
name: Longhua Hospital
First posted: 2018-02-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 60 patients were divided into a treatment group and a control group, with 30 cases in each group. The control group received health education，and the treatment group was treated with Ba Duan Jin plus health education program.
Primary purpose: TREATMENT

Brief summary: Many researches shows that Ba Duan Jin has clinical efficacy on cancer rehabilitation, respiratory diseases, psychological health, quality of life and so on. Studies examining the effects of Ba Duan Jin on patients with pulmonary nodules are sparse. Therefore, the aims of the present study are: 1) to examine the effects of Ba Duan Jin on physical and psychological condition, and 2) to examine the effects of Ba Duan Jin on quality of life.

Detailed description: In recent years, with advancement in computed tomography (CT) technology and its widespread use, pulmonary nodules are common incidental findings. Pulmonary nodules are used to appear as well-circumscribed radiographic opacity. They can be single or multiple. There are multiple causes of pulmonary nodules. Most nodules are benign, but some may also represent bronchogenic carcinoma or metastatic lesions. The prevalence of malignancy is detected nodules varies between 0.2% and 18%. Thus, the preoperative individuals would suffer from depression or anxiety caused by uncertain progression of pulmonary nodules; the postoperative individuals would suffer from both physical and mental trauma.

There is growing interest in non-pharmacological approaches that could potentially improve pulmonary nodules patients' physical condition, psychological condition and quality of life.

Ba Duan Jin, a traditional Chinese health-preserving technique, combines the traditional Chinese medicine and traditional Chinese philosophy and embrace the body, breath and spirit. There is substantial evidence that Ba Duan Jin has benefits for cancer rehabilitation, respiratory diseases, psychological health, and quality of life. The effects of Ba Duan Jin on patients with pulmonary nodules are yet to be further investigated.

The present pilot clinical study aims to apply Ba Duan Jin to patients with pulmonary nodules, and to evaluate the effects on physical (pulmonary function), psychological (depression and anxiety), and quality of life. Participants allocated to the Health Education Group take part in the 16-week health education including work, rest, diet and other basic programs according to the different conditions of participants. Participants allocated to the Ba Duan Jin Group take part in the 16-week Ba Duan Jin plus health education program. The study plans to enroll 60 participants in 2 years (30 for Ba Duan Jin plus health education program, and 30 for health education program), expecting that Ba Duan Jin has a better effect on improving physical condition, psychological condition and quality of life.

Eligibility criteria: Inclusion Criteria:

* Subject has been diagnosed by CT scan of the lung(s).
* Subject is male or female, age 18 to 75.
* Subject has a clear mind and the ability to read, to talk and to communicate.
* Subject agrees to participate in this study and sign to the informed consent.

Exclusion Criteria:

* Subject has recurrence of cancer.
* Subject has severe somatic disease.
* Subject has history of psychosis, mania, or severe personality.
* Subject is pregnant, lactating or breast-feeding women.
* Subject is engaging in other clinical trial.

Primary outcomes:
measure: Vital Capacity in liters (VC)
timeFrame: 16 weeks
measure: Forced Vital Capacity in liters (FVC)
timeFrame: 16 weeks
measure: Forced Expiratory Volume in one second in liters (FEV1)
timeFrame: 16 weeks
measure: FEV1/FVC in percents (FEV1%)
timeFrame: 16 weeks
measure: Peak Expiratory Flow in liters (PEF)
timeFrame: 16 weeks
measure: the Zung Self-Rating Anxiety Scale (SAS)
timeFrame: 16 weeks
measure: the Zung Self-Rating Depression Scale (SDS)
timeFrame: 16 weeks
Secondary outcomes:
measure: the MOS 36-Item Short Form Health Survey(SF-36)
timeFrame: 16 weeks
measure: CT scan of the Lung(s)
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Qigong Research Institute
state: Shanghai
Study officials:
affiliation: Shanghai Qigong Research Institute
name: Ying Lu
role: STUDY_DIRECTOR
References:
citation: Lu Y, Li J, Ni W, Li J, Song J, Jiang J, Zhao X. Effectiveness of mind-body exercise via Baduanjin on physical and psychological outcomes in patients with pulmonary ground-glass nodules: A non-randomized controlled pilot study. Complement Ther Clin Pract. 2023 Feb;50:101679. doi: 10.1016/j.ctcp.2022.101679. Epub 2022 Nov 9.