NCT02413840

Brief Summary

This study expect to investigate psychological intervention (Baduanjin qigong) in COPD patients combined with anxiety and/or depression.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 10, 2015

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Last Updated

April 10, 2015

Status Verified

April 1, 2015

Enrollment Period

5 months

First QC Date

February 4, 2015

Last Update Submit

April 7, 2015

Conditions

COPDAnxietyDepression

Keywords

COPDBaduanjin qigongdepressionanxiety

Outcome Measures

Primary Outcomes (1)

  • stage of anxiety and depression ((Hospital Anxiety and Depression Scale)

    use psychological questionnaires(Hospital Anxiety and Depression Scale,etc)to evaluate the stage of anxiety and/or depression

    one year

Secondary Outcomes (2)

  • the number of acute exacerbations

    one year

  • lung function (pulmonary function test(20 minutes after inhaled 400ug albuterol),the forced expiratory volume in 1 second(FEV1)will be detected)

    one year

Study Arms (2)

Baduanjin qigong group

EXPERIMENTAL

Doing exercise of Baduanjin qigong under the guidance of medical staff;psychological counseling at the same time.

Behavioral: Baduanjin qigong

control group

NO INTERVENTION

Psychological counseling only.

Interventions

Baduanjin qigongBEHAVIORAL
Baduanjin qigong group

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed of COPD
  • In stable phase
  • FEV1%predicted \<80.

You may not qualify if:

  • Cancer
  • Severe cerebrovascular disease
  • Severe arrhythmia,cardiac insufficiency
  • Alzheimer's disease
  • Mental illness
  • Severe liver disfunction
  • Severe renal disfunction
  • Physical activity disable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing institute of respiratory diseases

Beijing, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Ting Yang

    Capital Medical University

    STUDY CHAIR

Central Study Contacts

Huimin Gong

CONTACT

8613436379130570866508@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

February 4, 2015

First Posted

April 10, 2015

Study Start

December 1, 2014

Primary Completion

May 1, 2015

Last Updated

April 10, 2015

Record last verified: 2015-04

Locations

CN(1)