NCT03892629

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 27, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

April 1, 2019

Status Verified

March 1, 2019

Enrollment Period

6 months

First QC Date

March 26, 2019

Last Update Submit

March 28, 2019

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Other Outcomes (1)

  • The main TCM symptoms

    Baseline, 1 month, 2 months, 3 months, 6 months

Study Arms (4)

Baduanjin exercise group

EXPERIMENTAL

Participants in this group received Baduanjin exercise

Behavioral: Baduanjin exercise

Instrument rehabilitation group

ACTIVE COMPARATOR

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

Device: Instrument rehabilitation

Baduanjin Exercise and Instrument Rehabilitation

ACTIVE COMPARATOR

Participants in this group received both instrument rehabilitation and Baduanjin exercise

Behavioral: Baduanjin exerciseDevice: Instrument rehabilitation

No Intervention

NO INTERVENTION

Participants in this group only received routine drug-treatment

Interventions

Baduanjin exerciseBEHAVIORAL

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

Baduanjin Exercise and Instrument RehabilitationBaduanjin exercise group
Instrument rehabilitationDEVICE

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

Baduanjin Exercise and Instrument RehabilitationInstrument rehabilitation group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Shuguang Hospital

Shanghai, 201203, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Wei Zhang, Master

    Shanghai Shuguang Hospital

    STUDY CHAIR

Central Study Contacts

Meng Sun, Master

CONTACT

86-21-20256375gulik002@aliyun.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

March 26, 2019

First Posted

March 27, 2019

Study Start

April 1, 2019

Primary Completion

October 1, 2019

Study Completion

December 1, 2019

Last Updated

April 1, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)