ClinicalTrials.gg
CompletedNCT03420885Updated Apr 3, 2025

Effects of Ba Duan Jin for Patients With Pulmonary Nodules

An interventional study of Ba Duan Jin and Health Education in Pulmonary Nodules, sponsored by Shanghai University of Traditional Chinese Medicine. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-04-03.

Sponsored by Shanghai University of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Feb 2017, registered Jan 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 43 studies in Multiple Pulmonary Nodules with a site in China — 22 open to participants now, 24 under way, none of them phase 3. Multiple Pulmonary Nodules · China.

Enrollment
15th of 21
60 · median 138
Started
2017
the only one that year
No phase
18 of 43
12 open now
Registered
2nd of 43
by date

Among the 43 studies in Multiple Pulmonary Nodules with a site in China, this one is the 15th largest by enrollment of the 21 interventional ones that give a count, is the only one that started in 2017, is one of 18 with no phase, and was the 2nd registered.

Multiple Pulmonary Nodules

99 studies on the registry are indexed under Multiple Pulmonary Nodules; 42 are open to participants now.

This study's enrollment of 60 is below the median of 97 across 46 interventional studies indexed under Multiple Pulmonary Nodules.

Browse Multiple Pulmonary Nodules studies →

Open to participants now

22 of the 43 studies in Multiple Pulmonary Nodules with a site in China are open now, in 1 country. Each count lists the studies.

All 22 open studies →

Where they have run

Who these studies take

Of the 17 Multiple Pulmonary Nodules studies recruiting now, 11 (65%) set no upper age limit and 3 (18%) stop at 75 or younger; 1 take children under 18; 3 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 43 studies in Multiple Pulmonary Nodules with a site in China, or all of them as a file.
02

Study 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.

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.

03

Conditions studied

  • Pulmonary Nodules

Keywords

  • Ba Duan Jin
  • Pulmonary Nodules
  • Clinical Intervention
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Ba Duan Jin Group

    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.

    Behavioral: Ba Duan Jin · Behavioral: Health Education

  • Active comparator
    Health Education Group

    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.

    Behavioral: Health Education

Interventions

  • BehavioralBa Duan Jin

    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.

    Also known as: Eight-section Brocade

  • BehavioralHealth Education

    Health education includes work, rest, diet and other basic programs according to the different conditions of participants.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 16 weeks

  2. 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.

    Time frame: 16 weeks

  3. 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.

    Time frame: 16 weeks

  4. FEV1/FVC in percents (FEV1%)

    FEV1% is the ratio of FEV1 to FVC.

    Time frame: 16 weeks

  5. 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.

    Time frame: 16 weeks

  6. 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.

    Time frame: 16 weeks

  7. 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.

    Time frame: 16 weeks

Secondary outcomes

  1. 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.

    Time frame: 16 weeks

  2. 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.

    Time frame: 16 weeks

07

Study locations

1 site
  • Shanghai Qigong Research Institute
    Shanghai, Shanghai 021, China
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2017 to primary completion in Dec 2019, 34 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 7, 2018
First posted
Feb 5, 2018
StartActual
Feb 18, 2017
Primary completionActual
Dec 31, 2019
CompletionActual
Jan 15, 2020
Last update
Apr 3, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03420885
Collaborators
Shanghai Yueyang Integrated Medicine Hospital, Longhua Hospital
Responsible party
Lu Ying, MM (assistant researcher, Shanghai University of Traditional Chinese Medicine) — Principal investigator
First posted
Feb 5, 2018
Start date
Feb 18, 2017
Primary completion
Dec 31, 2019
Completion
Jan 15, 2020
Last update
Apr 3, 2025

Study contacts

Ying Lu
study director · Shanghai Qigong Research Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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