Pulmonary NodulesNCT03420885
Effects of Ba Duan Jin for Patients With Pulmonary Nodules
A study testing Ba Duan Jin and Health Education in people with Pulmonary Nodules, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Nodules
- What is being tested?
- Ba Duan Jin and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 18 Feb 2017to 15 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Qigong Research Institute
Shanghai, Shanghai Municipality, 021
About this study
Official title: Ba Duan Jin for Patients With Pulmonary Nodules on Physical Condition, Psychological Condition and Quality of Life: A Pilot Clinical Study
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.
Read the 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.
- Conditions
- Pulmonary Nodules
- Being tested
- Ba Duan Jin, Health Education
- Keywords
- Ba Duan Jin, Pulmonary Nodules, Clinical Intervention
- Medical subject headings
- Multiple Pulmonary Nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ba Duan JinBehavioural
Also called Eight-section Brocade
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. Ba Duan Jin consists of eight main movements. According to traditional theory, every movement has unique effect to different Zang-fu organs.
Health EducationBehavioural
Health education includes work, rest, diet and other basic programs according to the different conditions of participants.
| Study group | Role | What they receive |
|---|---|---|
| Ba Duan Jin Group | Experimental | Ba Duan Jin plus health education. Participants take part in 16-week program. The health education is conducted as the Health Education Group. Besides, the participants attended two 90-minute sessions of group-based Ba Duan Jin training per week and practiced at least three 30-minute Ba Duan Jin sessions at home per day. Receives: Behavioral: Ba Duan Jin; Behavioral: Health Education |
| Health Education Group | Active comparator | Health education. Participants take part in 16-week program. The health education includes work, rest, diet and other basic programs according to the different conditions of participants. Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital Capacity in liters (VC)
VC, a measure of pulmonary function, is the maximum amount of air a person can expel from the lungs after a maximum inhalation.
Measured: 16 weeks
Forced Vital Capacity in liters (FVC)
FVC, a measure of pulmonary function, is the volume of air that can forcibly be blown out after full inspiration.
Measured: 16 weeks
Forced Expiratory Volume in one second in liters (FEV1)
FEV1, a measure of pulmonary function, is the volume of air that can forcibly be blown out in one second, after full inspiration.
Measured: 16 weeks
FEV1/FVC in percents (FEV1%)
FEV1% is the ratio of FEV1 to FVC.
Measured: 16 weeks
Peak Expiratory Flow in liters (PEF)
PEF, a measure of pulmonary function, is the maximal flow (or speed) achieved during the maximally forced expiration initiated at full inspiration.
Measured: 16 weeks
the Zung Self-Rating Anxiety Scale (SAS)
The SAS, designed by Duke University psychiatrist William W.K. Zung MD, is a 20-item self-report assessment built to measure anxiety level. Each items points accumulated as raw score, then the raw score will be converted into a percentage (the SAS index); the higher the SAS index, the greater the severity of anxious symptoms.
Measured: 16 weeks
the Zung Self-Rating Depression Scale (SDS)
The SDS, designed by Duke University psychiatrist William W.K. Zung MD, is a 20-item self-report assessment built to measure depression level. Each items points accumulated as raw score, then the raw score will be converted into a percentage (the SDS index); the higher the SDS index, the greater the severity of depressive symptoms.
Measured: 16 weeks
Secondary outcomes (2)
the MOS 36-Item Short Form Health Survey(SF-36)
The SF-36 is a 36-item, patient-report survey of patient health status. It consists of eight scaled scores and each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. Higher scores indicate a better health-related quality of life.
Measured: 16 weeks
CT scan of the Lung(s)
Follow-up CT scan imaging is required to observe the changes of pulmonary nodules in size, density, type and so on.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start18 Feb 2017
- Primary completion31 Dec 2019
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary NodulesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Yueyang Integrated Medicine Hospital, Longhua Hospital
- Responsible party
- Principal investigator, Lu Ying, MM, Shanghai University of Traditional Chinese Medicine
- Investigators
- Ying Lu, Study director, Shanghai Qigong Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420885
- Sponsor's protocol ID
- 2016YSN31
- Status last verified
- Mar 2025
- First submitted
- 7 Jan 2018
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36399997
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ba Duan Jin for Patients With Pulmonary Nodules on Physical Condition, Psychological Condition and Quality of Life: A Pilot Clinical Study
- ClinicalTrials.gov ID
- NCT03420885
- Acronym / sponsor ID
- 2016YSN31
- Conditions
- Pulmonary Nodules
- Keywords
- Ba Duan Jin, Pulmonary Nodules, Clinical Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Shanghai Yueyang Integrated Medicine Hospital, Longhua Hospital
- Study start
- 18 Feb 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 5 Feb 2018 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ba Duan Jin Group | Experimental | Behavioral: Ba Duan Jin, Behavioral: Health EducationBa Duan Jin plus health education. Participants take part in 16-week program. The health education is conducted as the Health Education Group. Besides, the participants attended two 90-minute sessions of group-based Ba Duan Jin training per week and practiced at least three 30-minute Ba Duan Jin sessions at home per day. |
| Health Education Group | Active comparator | Behavioral: Health EducationHealth education. Participants take part in 16-week program. The health education includes work, rest, diet and other basic programs according to the different conditions of participants. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Ba Duan JinAlso: Eight-section BrocadeBa Duan Jin, a traditional Chinese health-preserving technique, combines the traditional Chinese medicine and traditional Chinese philosophy and embrace the body, breath and spirit. Ba Duan Jin consists of eight main movements. According to traditional theory, every movement has unique effect to different Zang-fu organs. | Behavioural | Ba Duan Jin Group |
| Health EducationHealth education includes work, rest, diet and other basic programs according to the different conditions of participants. | Behavioural | Ba Duan Jin Group, Health Education Group |
Primary outcome
Vital Capacity in liters (VC)
Time frame: 16 weeks
VC, a measure of pulmonary function, is the maximum amount of air a person can expel from the lungs after a maximum inhalation.
Forced Vital Capacity in liters (FVC)
Time frame: 16 weeks
FVC, a measure of pulmonary function, is the volume of air that can forcibly be blown out after full inspiration.
Forced Expiratory Volume in one second in liters (FEV1)
Time frame: 16 weeks
FEV1, a measure of pulmonary function, is the volume of air that can forcibly be blown out in one second, after full inspiration.
FEV1/FVC in percents (FEV1%)
Time frame: 16 weeks
FEV1% is the ratio of FEV1 to FVC.
Peak Expiratory Flow in liters (PEF)
Time frame: 16 weeks
PEF, a measure of pulmonary function, is the maximal flow (or speed) achieved during the maximally forced expiration initiated at full inspiration.
the Zung Self-Rating Anxiety Scale (SAS)
Time frame: 16 weeks
The SAS, designed by Duke University psychiatrist William W.K. Zung MD, is a 20-item self-report assessment built to measure anxiety level. Each items points accumulated as raw score, then the raw score will be converted into a percentage (the SAS index); the higher the SAS index, the greater the severity of anxious symptoms.
the Zung Self-Rating Depression Scale (SDS)
Time frame: 16 weeks
The SDS, designed by Duke University psychiatrist William W.K. Zung MD, is a 20-item self-report assessment built to measure depression level. Each items points accumulated as raw score, then the raw score will be converted into a percentage (the SDS index); the higher the SDS index, the greater the severity of depressive symptoms.
2 secondary outcomes
the MOS 36-Item Short Form Health Survey(SF-36)
Time frame: 16 weeks
CT scan of the Lung(s)
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Derived from this study: PubMed 36399997Lu 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.
- 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. This study is not recruiting at the moment.
Ying Lu study director
Shanghai Qigong Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ba Duan Jin and Health Education in people with Pulmonary Nodules, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
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: finished, as of the sponsor's last update on 3 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vital Capacity in liters (VC) (time frame: 16 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03420885, which also lists 1 linked publication.
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 3 Apr 2025.