Ba Duan Jin for Patients With Pulmonary Nodules on Physical Condition, Psychological Condition and Quality of Life: A Pilot Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Forced Vital Capacity in liters (FVC)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The study was a single-blind controlled trial in which the outcome assessor was blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has been diagnosed by CT scan of the lung(s).
- •Subject is male or female, age 18 to
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Ba Duan Jin (Behavioral)
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.
干预措施: Health Education (Behavioral)
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.
干预措施: Health Education (Behavioral)
结局指标
主要结局
Forced Vital Capacity in liters (FVC)
时间窗: 16 weeks
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)
时间窗: 16 weeks
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%)
时间窗: 16 weeks
FEV1% is the ratio of FEV1 to FVC.
Peak Expiratory Flow in liters (PEF)
时间窗: 16 weeks
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)
时间窗: 16 weeks
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.
Vital Capacity in liters (VC)
时间窗: 16 weeks
VC, a measure of pulmonary function, is the maximum amount of air a person can expel from the lungs after a maximum inhalation.
the Zung Self-Rating Depression Scale (SDS)
时间窗: 16 weeks
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.
次要结局
- CT scan of the Lung(s)(16 weeks)
- the MOS 36-Item Short Form Health Survey(SF-36)(16 weeks)
研究者
Lu Ying, MM
assistant researcher
Shanghai University of Traditional Chinese Medicine