Supine Daoyin in the Treatment of AECOPD

NCT ID: NCT04913961

Last Updated: 2022-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-12-31

Brief Summary

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The purpose of this study was to evaluate the clinical efficacy and safety of supine daoyin in the treatment of AECOPD.

Detailed Description

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Chronic obstructive pulmonary disease (COPD) is a chronic progressive disease with high incidence rate, high mortality rate and high disability rate. Among the people over 40, the prevalence rate is 10.1%, while the prevalence rate in China is 13.7%. Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is a major event that affects the natural course of COPD. In particular, most patients with AECOPD have poor prognosis, higher morbidity and mortality, and lower quality of life. Pulmonary rehabilitation can improve the clinical symptoms of AECOPD patients, increase exercise tolerance, delay the decline of lung function, and improve the quality of life. In recent years, the clinical research on the rehabilitation of patients with AECOPD is still in the exploratory stage, which needs to be supported by clear evidence.

This is a multicenter, randomized controlled trial to evaluate the clinical efficacy and safety of supine daoyin in the treatment of AECOPD. After admission, the patients were randomly divided into two groups, rehabilitation group and control group, 114 cases in each group. After routine treatment, the patients began to recover when they reached the initial rehabilitation standard, and recovered until they reached the discharge standard. The primary outcomes are the length of hospital stay due to acute exacerbation and clinical symptom score. The secondary outcomes include activities of daily living, dyspnea score, 6-minute walking distance, lower limb muscle strength, mechanical ventilation and quality of life. Safety will also be assessed.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Supine Daoyin

During hospitalization, the rehabilitation group will receive conventional western medicine treatment and supine guidance therapy which consists of training and patient education. They will be evaluated with some tests for the study.

Group Type EXPERIMENTAL

Supine Daoyin

Intervention Type OTHER

During hospitalization, the rehabilitation group will receive conventional western medicine treatment and supine guidance therapy which consists of training and patient education. They will be evaluated with some tests for the study

Control

The control group will get the western medicine conventional therapy with some additional tests for the study.

Group Type ACTIVE_COMPARATOR

western medicine conventional therapy

Intervention Type OTHER

The control group will get the western medicine conventional therapy with some additional tests for the study.

Interventions

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Supine Daoyin

During hospitalization, the rehabilitation group will receive conventional western medicine treatment and supine guidance therapy which consists of training and patient education. They will be evaluated with some tests for the study

Intervention Type OTHER

western medicine conventional therapy

The control group will get the western medicine conventional therapy with some additional tests for the study.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. A confirmed diagnosis of AECOPD.
2. Age between 40 and 80 years.
3. mMRC score ≥ 3.
4. Barthel index\<50.
5. With the informed consent signed.

Exclusion Criteria

1. Patients with severe cognitive impairment, dementia and various psychosis.
2. Combined with severe arthritis and other osteoarthritis affecting the movement.
3. Dyskinesia due to neuromuscular diseases.
4. Long term bedridden for various reasons.
5. Participating in other trials.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henan University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Li jiansheng, doctor

Role: STUDY_CHAIR

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Locations

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The First Affiliated Hospital of Henan University of Chinese

Zhengzhou, Henan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhang hailong, doctor

Role: CONTACT

+86 371 66248624

Li jiansheng, doctor

Role: CONTACT

Facility Contacts

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jiansheng Li, doctor

Role: primary

+86 371 66248624

hailong zhang, doctor

Role: backup

+86 371 66248624

Other Identifiers

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Daoyin for AECOPD

Identifier Type: -

Identifier Source: org_study_id

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