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Effects of Ba Duan Jin for Patients With Pulmonary Nodules

Primary Purpose

Pulmonary Nodules

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ba Duan Jin
Health Education
Sponsored by
Shanghai University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Nodules focused on measuring Ba Duan Jin, Pulmonary Nodules, Clinical Intervention

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Qigong Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ba Duan Jin Group

Health Education Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
FEV1/FVC in percents (FEV1%)
FEV1% is the ratio of FEV1 to FVC.
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.
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
January 7, 2018
Last Updated
March 19, 2020
Sponsor
Shanghai University of Traditional Chinese Medicine
Collaborators
Shanghai Yueyang Integrated Medicine Hospital, Longhua Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03420885
Brief Title
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

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
February 18, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
January 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai University of Traditional Chinese Medicine
Collaborators
Shanghai Yueyang Integrated Medicine Hospital, Longhua Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Nodules
Keywords
Ba Duan Jin, Pulmonary Nodules, Clinical Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
The study was a single-blind controlled trial in which the outcome assessor was blinded to group allocation.
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ba Duan Jin Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Health Education Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Ba Duan Jin
Other Intervention Name(s)
Eight-section Brocade
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Intervention Description
Health education includes work, rest, diet and other basic programs according to the different conditions of participants.
Primary Outcome Measure Information:
Title
Vital Capacity in liters (VC)
Description
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
Title
Forced Vital Capacity in liters (FVC)
Description
FVC, a measure of pulmonary function, is the volume of air that can forcibly be blown out after full inspiration.
Time Frame
16 weeks
Title
Forced Expiratory Volume in one second in liters (FEV1)
Description
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
Title
FEV1/FVC in percents (FEV1%)
Description
FEV1% is the ratio of FEV1 to FVC.
Time Frame
16 weeks
Title
Peak Expiratory Flow in liters (PEF)
Description
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
Title
the Zung Self-Rating Anxiety Scale (SAS)
Description
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
Title
the Zung Self-Rating Depression Scale (SDS)
Description
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 Outcome Measure Information:
Title
the MOS 36-Item Short Form Health Survey(SF-36)
Description
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
Title
CT scan of the Lung(s)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying Lu
Organizational Affiliation
Shanghai Qigong Research Institute
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Qigong Research Institute
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
021
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36399997
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.
Results Reference
derived

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Effects of Ba Duan Jin for Patients With Pulmonary Nodules

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