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

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Behavioral: Baduanjin exercise; Device: Instrument rehabilitation

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 Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 201203
    • Shanghai Shuguang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Baduanjin exercise group; Participants in this group received Baduanjin exercise	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
Active Comparator: Instrument rehabilitation group; Participants in this group received rehabilitation by using tri-ball respiratory trainer	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
Active Comparator: Baduanjin Exercise and Instrument Rehabilitation; Participants in this group received both instrument rehabilitation and Baduanjin exercise	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
No Intervention: No Intervention; Participants in this group only received routine drug-treatment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmanory function indicators (FEV1/FVC, FEV1pred%)	Assessing changes of airway limitation	Baseline, 3 months, 6 months
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
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
Times of acute exacerbation	Recording the frequency of acute exacerbation	Baseline, 1 month, 2 months, 3 months, 6 months
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: ShuGuang Hospital
• Collaborators: Shanghai Zhongshan Hospital
• Investigators: Study Chair: Wei Zhang, Master, Shanghai Shuguang Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2019
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: March 26, 2019
• First Submitted That Met QC Criteria: March 26, 2019
• First Posted (Actual): March 27, 2019

Study Record Updates

• Last Update Posted (Actual): April 1, 2019
• Last Update Submitted That Met QC Criteria: March 28, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2018YFC1313601003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No