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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02413840
Other study ID # CMU900314
Secondary ID
Status Recruiting
Phase N/A
First received February 4, 2015
Last updated April 7, 2015
Start date December 2014

Study information

Verified date April 2015
Source Capital Medical University
Contact Huimin Gong
Phone 8613436379130
Email 570866508@qq.com
Is FDA regulated No
Health authority China: Beijing Municipal Health Bureau
Study type Interventional

Clinical Trial Summary

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


Description:

Anxiety and depression is one of the most common complications of COPD patients.This research use psychological questionnaires to evaluate the stage of COPD patients with anxiety and/or depression(asymptomatic, subclinical,clinical). The subclinical type will divided into the treatment group of Baduanjin qigong,and the control group. Two groups are all receive the same psychological counseling, the treatment group also receive further treatment of Baduanjin qigong under the guidance of medical staff. The treatment along for 1 year. Two groups were followed up for 2 years, dynamically observe the stage of anxiety and depression,the number of exacerbations,lung function,etc.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 75 Years
Eligibility Inclusion Criteria:

- Diagnosed of COPD

- In stable phase

- FEV1%predicted <80.

Exclusion Criteria:

- Cancer

- Severe cerebrovascular disease

- Severe arrhythmia,cardiac insufficiency

- Alzheimer's disease

- Mental illness

- Severe liver disfunction

- Severe renal disfunction

- Physical activity disable.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Baduanjin qigong


Locations

Country Name City State
China Beijing institute of respiratory diseases Beijing

Sponsors (1)

Lead Sponsor Collaborator
Huimin Gong

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary the number of acute exacerbations one year No
Secondary lung function (pulmonary function test(20 minutes after inhaled 400ug albuterol),the forced expiratory volume in 1 second(FEV1)will be detected) use pulmonary function test(20 minutes after inhaled 400ug albuterol),the forced expiratory volume in 1 second(FEV1)will be detected. one year No
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