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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Baduanjin exercise
Instrument rehabilitation
Sponsored by
ShuGuang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai Shuguang Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

No Intervention

Arm Label

Baduanjin exercise group

Instrument rehabilitation group

Baduanjin Exercise and Instrument Rehabilitation

No Intervention

Arm Description

Participants in this group received Baduanjin exercise

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

Participants in this group received both instrument rehabilitation and Baduanjin exercise

Participants in this group only received routine drug-treatment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pulmanory function indicators (FEV1/FVC, FEV1pred%)
Assessing changes of airway limitation
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
COPD assessment test (CAT)
Assessing the quality of life, the total score ranges from 0-40, the higher score represent a worse outcome
Times of acute exacerbation
Recording the frequency of acute exacerbation
Self-rating anxiety scale (SAS)
Evaluating the stage of anxiety, the total score ranges from 20-80, the higher score represent a worse outcome
Self-rating depression scale (SDS)
Evaluating the stage of depression, the total score ranges from 20-80, the higher score represent a worse outcome

Full Information

First Posted
March 26, 2019
Last Updated
March 28, 2019
Sponsor
ShuGuang Hospital
Collaborators
Shanghai Zhongshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03892629
Brief Title
Baduanjin Exercise for Patients With GOLD 2-3 Stable COPD on Pulmonary Rehabilitation
Official Title
Baduanjin Exercise for Patients With GOLD 2-3 Stable Chronic Obstructive Pulmonary Disease on Pulmonary Rehabilitation: A Prospective, Randomized, Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 2019 (Anticipated)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
ShuGuang Hospital
Collaborators
Shanghai Zhongshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Baduanjin exercise group
Arm Type
Experimental
Arm Description
Participants in this group received Baduanjin exercise
Arm Title
Instrument rehabilitation group
Arm Type
Active Comparator
Arm Description
Participants in this group received rehabilitation by using tri-ball respiratory trainer
Arm Title
Baduanjin Exercise and Instrument Rehabilitation
Arm Type
Active Comparator
Arm Description
Participants in this group received both instrument rehabilitation and Baduanjin exercise
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
Participants in this group only received routine drug-treatment
Intervention Type
Behavioral
Intervention Name(s)
Baduanjin exercise
Intervention Description
Participants received Baduanjin exercise. Each Baduanjin exercise session lasts 30 minutes and continues twice a day, 5 times per week for 12 weeks
Intervention Type
Device
Intervention Name(s)
Instrument rehabilitation
Intervention Description
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
Primary Outcome Measure Information:
Title
St. George's respiratory questionnaire (SGRQ)
Description
Evaluating the changes of impact on quality of life
Time Frame
Baseline, 3 months, 6 months
Title
Six-minute walk test (6MWT)
Description
Testing patients changes on walking distance and accompanies symptoms in 6 minutes
Time Frame
Baseline, 3 months, 6 months
Secondary Outcome Measure Information:
Title
Pulmanory function indicators (FEV1/FVC, FEV1pred%)
Description
Assessing changes of airway limitation
Time Frame
Baseline, 3 months, 6 months
Title
Modified British medical research council questionnaire (mMRC)
Description
Evaluating the severity of dyspnea, totally has 5 grade from 0-4, the higher grade represent a severer symptom
Time Frame
Baseline, 1 month, 2 months, 3 months, 6 months
Title
COPD assessment test (CAT)
Description
Assessing the quality of life, the total score ranges from 0-40, the higher score represent a worse outcome
Time Frame
Baseline, 1 month, 2 months, 3 months, 6 months
Title
Times of acute exacerbation
Description
Recording the frequency of acute exacerbation
Time Frame
Baseline, 1 month, 2 months, 3 months, 6 months
Title
Self-rating anxiety scale (SAS)
Description
Evaluating the stage of anxiety, the total score ranges from 20-80, the higher score represent a worse outcome
Time Frame
Baseline, 3 months, 6 months
Title
Self-rating depression scale (SDS)
Description
Evaluating the stage of depression, the total score ranges from 20-80, the higher score represent a worse outcome
Time Frame
Baseline, 3 months, 6 months
Other Pre-specified Outcome Measures:
Title
The main TCM symptoms
Description
The changes of scores of TCM syndromes, the total score ranges from 0-15, the higher score represent a worse outcome
Time Frame
Baseline, 1 month, 2 months, 3 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meng Sun, Master
Phone
86-21-20256375
Email
gulik002@aliyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Zhang, Master
Organizational Affiliation
Shanghai Shuguang Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai Shuguang Hospital
City
Shanghai
ZIP/Postal Code
201203
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meng Sun, Master
Phone
86-21-20256375
Email
gulik002@aliyun.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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