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

Not Applicable

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Behavioral: Baduanjin exercise; Device: Instrument rehabilitation

• Registration Number: NCT03892629
• Lead Sponsor: ShuGuang Hospital

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2019-03
• Study First Submitted: 2019-03-26
• Study First Submitted QC: 2019-03-26
• Study First Posted: 2019-03-27
• Last Update Submitted: 2019-03-28
• Study Start: 2019-04
• Last Update Posted: 2019-04-01
• Primary Completion: 2019-10
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Baduanjin exercise group	Baduanjin exercise	Participants in this group received Baduanjin exercise
Instrument rehabilitation group	Instrument rehabilitation	Participants in this group received rehabilitation by using tri-ball respiratory trainer
Baduanjin Exercise and Instrument Rehabilitation	Baduanjin exercise	Participants in this group received both instrument rehabilitation and Baduanjin exercise
Baduanjin Exercise and Instrument Rehabilitation	Instrument rehabilitation	Participants in this group received both instrument rehabilitation and Baduanjin exercise

Primary Outcome Measures

Name	Time	Method
St. George's respiratory questionnaire (SGRQ)	Baseline, 3 months, 6 months	Evaluating the changes of impact on quality of life
Six-minute walk test (6MWT)	Baseline, 3 months, 6 months	Testing patients changes on walking distance and accompanies symptoms in 6 minutes

Secondary Outcome Measures

Name	Time	Method
Pulmanory function indicators (FEV1/FVC, FEV1pred%)	Baseline, 3 months, 6 months	Assessing changes of airway limitation
Modified British medical research council questionnaire (mMRC)	Baseline, 1 month, 2 months, 3 months, 6 months	Evaluating the severity of dyspnea, totally has 5 grade from 0-4, the higher grade represent a severer symptom
COPD assessment test (CAT)	Baseline, 1 month, 2 months, 3 months, 6 months	Assessing the quality of life, the total score ranges from 0-40, the higher score represent a worse outcome
Times of acute exacerbation	Baseline, 1 month, 2 months, 3 months, 6 months	Recording the frequency of acute exacerbation
Self-rating anxiety scale (SAS)	Baseline, 3 months, 6 months	Evaluating the stage of anxiety, the total score ranges from 20-80, the higher score represent a worse outcome
Self-rating depression scale (SDS)	Baseline, 3 months, 6 months	Evaluating the stage of depression, the total score ranges from 20-80, the higher score represent a worse outcome

Trial Locations

Locations (1)

Shanghai Shuguang Hospital; 🇨🇳 Shanghai, China