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
Verified date | September 2019 |
Source | Shanghai University of Traditional Chinese Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Qigong Research Institute | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai University of Traditional Chinese Medicine | Longhua Hospital, Shanghai Yueyang Integrated Medicine Hospital |
China,
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 |
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