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临床试验/NCT03892629
NCT03892629Unknown不适用

Baduanjin Exercise for Patients With GOLD 2-3 Stable Chronic Obstructive Pulmonary Disease on Pulmonary Rehabilitation: A Prospective, Randomized, Controlled Clinical Trial

ShuGuang Hospital1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2019年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
240
试验地点
1
主要终点
St. George's respiratory questionnaire (SGRQ)

研究概览

简要总结

Chronic Obstructive Pulmonary Disease (COPD) is a disease with a very high morbidity and mortality rate. When the lung function drops lower and lower, patients will bear great affliction physically and mentally. How to improve the quality of life in patients with COPD is a hot topic in the study of COPD now. Baduanjin, as one of the traditional Chinese qigong exercises, has the features of generous stretch, soft consistency, dynamic but static, which is an appropriate movement pattern for COPD patients.

详细描述

To investigate the efficacy of Baduanjin exercise for patients with stable chronic obstructive pulmonary disease on phase II~III. A prospective, randomized, controlled clinical trial was designed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Aged from 40 to 80 years
  • •Diagnosed with stable chronic obstructive pulmonary disease
  • •Phase II~III

排除标准

  • •The condition was serious or movement restrained by other diseases
  • •In the acute exacerbation of chronic obstructive pulmonary disease
  • •Participants who have contraindications to exercise training
  • •Patients who have other serious acute, chronic organic disease or mental disorders

研究组 & 干预措施

Baduanjin exercise group

Experimental

Participants in this group received Baduanjin exercise

干预措施: Baduanjin exercise (Behavioral)

Instrument rehabilitation group

Active Comparator

Participants in this group received rehabilitation by using tri-ball respiratory trainer

干预措施: Instrument rehabilitation (Device)

Baduanjin Exercise and Instrument Rehabilitation

Active Comparator

Participants in this group received both instrument rehabilitation and Baduanjin exercise

干预措施: Baduanjin exercise (Behavioral)

Baduanjin Exercise and Instrument Rehabilitation

Active Comparator

Participants in this group received both instrument rehabilitation and Baduanjin exercise

干预措施: Instrument rehabilitation (Device)

No Intervention

No Intervention

Participants in this group only received routine drug-treatment

结局指标

主要结局

St. George's respiratory questionnaire (SGRQ)

时间窗: Baseline, 3 months, 6 months

Evaluating the changes of impact on quality of life

Six-minute walk test (6MWT)

时间窗: Baseline, 3 months, 6 months

Testing patients changes on walking distance and accompanies symptoms in 6 minutes

次要结局

  • Pulmanory function indicators (FEV1/FVC, FEV1pred%)(Baseline, 3 months, 6 months)
  • Modified British medical research council questionnaire (mMRC)(Baseline, 1 month, 2 months, 3 months, 6 months)
  • COPD assessment test (CAT)(Baseline, 1 month, 2 months, 3 months, 6 months)
  • Times of acute exacerbation(Baseline, 1 month, 2 months, 3 months, 6 months)
  • Self-rating anxiety scale (SAS)(Baseline, 3 months, 6 months)
  • Self-rating depression scale (SDS)(Baseline, 3 months, 6 months)

研究者

发起方
ShuGuang Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sun Meng

Attending Physician

ShuGuang Hospital

研究点 (1)

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