Baduanjin Exercise for Patients With GOLD 2-3 Stable COPD on Pulmonary Rehabilitation

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03892629
• Other study ID #: 2018YFC1313601003
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2019
• Est. completion date: December 2019

Study information

• Verified date: March 2019
• Source: ShuGuang Hospital
• Contact: Meng Sun, Master
• Phone: 86-21-20256375
• Email: gulik002[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: December 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Aged from 40 to 80 years

• Diagnosed with stable chronic obstructive pulmonary disease

• Phase II~III

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Baduanjin exercise
Participants received Baduanjin exercise. Each Baduanjin exercise session lasts 30 minutes and continues twice a day, 5 times per week for 12 weeks

Device:
• Instrument rehabilitation
Participants received pulmanory rehabilitation by using tri-ball respiratory trainer. Each instrument exercise session lasts 30 minutes and continues twice a day, 5 times per week for 12 weeks

Locations

Country	Name	City	State
China	Shanghai Shuguang Hospital	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
ShuGuang Hospital	Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The main TCM symptoms	The changes of scores of TCM syndromes, the total score ranges from 0-15, the higher score represent a worse outcome	Baseline, 1 month, 2 months, 3 months, 6 months
Primary	St. George's respiratory questionnaire (SGRQ)	Evaluating the changes of impact on quality of life	Baseline, 3 months, 6 months
Primary	Six-minute walk test (6MWT)	Testing patients changes on walking distance and accompanies symptoms in 6 minutes	Baseline, 3 months, 6 months
Secondary	Pulmanory function indicators (FEV1/FVC, FEV1pred%)	Assessing changes of airway limitation	Baseline, 3 months, 6 months
Secondary	Modified British medical research council questionnaire (mMRC)	Evaluating the severity of dyspnea, totally has 5 grade from 0-4, the higher grade represent a severer symptom	Baseline, 1 month, 2 months, 3 months, 6 months
Secondary	COPD assessment test (CAT)	Assessing the quality of life, the total score ranges from 0-40, the higher score represent a worse outcome	Baseline, 1 month, 2 months, 3 months, 6 months
Secondary	Times of acute exacerbation	Recording the frequency of acute exacerbation	Baseline, 1 month, 2 months, 3 months, 6 months
Secondary	Self-rating anxiety scale (SAS)	Evaluating the stage of anxiety, the total score ranges from 20-80, the higher score represent a worse outcome	Baseline, 3 months, 6 months
Secondary	Self-rating depression scale (SDS)	Evaluating the stage of depression, the total score ranges from 20-80, the higher score represent a worse outcome	Baseline, 3 months, 6 months