Effects of Ba Duan Jin for Patients With Pulmonary Nodules

Pulmonary Nodules Clinical Trial

Official title:

Ba Duan Jin for Patients With Pulmonary Nodules on Physical Condition, Psychological Condition and Quality of Life: A Pilot Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03420885
• Other study ID #: 2016YSN31
• Status: Completed
• Phase: N/A
• Start date: February 18, 2017
• Est. completion date: January 15, 2020

Study information

• Verified date: September 2019
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 15, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Pulmonary Nodules

Intervention

Behavioral:
• Ba 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.
• Health Education
Health education includes work, rest, diet and other basic programs according to the different conditions of participants.

Locations

Country	Name	City	State
China	Shanghai Qigong Research Institute	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine	Longhua Hospital, Shanghai Yueyang Integrated Medicine Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	FEV1/FVC in percents (FEV1%)	FEV1% is the ratio of FEV1 to FVC.	16 weeks
Primary	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
Primary	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
Primary	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	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.	16 weeks
Secondary	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.	16 weeks