NCT03420885

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 18, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
Last Updated

April 3, 2025

Status Verified

March 1, 2025

Enrollment Period

2.9 years

First QC Date

January 7, 2018

Last Update Submit

March 29, 2025

Conditions

Pulmonary Nodules

Keywords

Ba Duan JinPulmonary NodulesClinical Intervention

Outcome Measures

Primary Outcomes (7)

  • 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.

    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.

    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.

    16 weeks

  • FEV1/FVC in percents (FEV1%)

    FEV1% is the ratio of FEV1 to FVC.

    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.

    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.

    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.

    16 weeks

Secondary Outcomes (2)

  • the MOS 36-Item Short Form Health Survey(SF-36)

    16 weeks

  • CT scan of the Lung(s)

    16 weeks

Study Arms (2)

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.

Behavioral: Ba Duan JinBehavioral: 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.

Behavioral: Health Education

Interventions

Ba Duan JinBEHAVIORAL

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
Ba Duan Jin Group
Health EducationBEHAVIORAL

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

Ba Duan Jin GroupHealth Education Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Qigong Research Institute

Shanghai, Shanghai Municipality, 021, China

Location

Related Publications (1)

  • 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.

    PMID: 36399997DERIVED

MeSH Terms

Conditions

Multiple Pulmonary Nodules

Condition Hierarchy (Ancestors)

Lung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Ying Lu

    Shanghai Qigong Research Institute

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The study was a single-blind controlled trial in which the outcome assessor was blinded to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant researcher

Study Record Dates

First Submitted

January 7, 2018

First Posted

February 5, 2018

Study Start

February 18, 2017

Primary Completion

December 31, 2019

Study Completion

January 15, 2020

Last Updated

April 3, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)