NCT04913961

Brief Summary

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

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
228

participants targeted

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

Timeline
Completed

Started Mar 2021

Typical duration 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

Study Start

First participant enrolled

March 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 4, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 4, 2022

Status Verified

January 1, 2022

Enrollment Period

2.8 years

First QC Date

April 26, 2021

Last Update Submit

January 3, 2022

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic obstructive pulmonary diseaseAcute exacerbationPulmonary rehabilitationSupine DaoyinRandomized controlled trail

Outcome Measures

Primary Outcomes (2)

  • Length of hospital stay due to acute exacerbation

    The time from hospitalization to discharge was counted

    through study completion, an average of 2 weeks

  • Clinical symptom assessment questionnaire (CCQ)

    The Clinical symptom assessment questionnaire (CCQ) is a self-administered questionnaire that measures health-related quality of life. It is an 10-item questionnaire on a 0-6 point scale with higher values indicating greater impact of COPD.

    Change from baseline CCQ scores at day 3，day 7，day 14

Secondary Outcomes (8)

  • Activities of daily living (Barthel index)

    Change from baseline Barthel index scores at day 3，day 7，day 14

  • Borg dyspnea score

    Change from baseline Borg dyspnea score at day 3，day 7，day 14

  • 30-second sit-to-stand test

    Change from baseline 30-second sit-to-stand test at day 3，day 7，day 14

  • Mechanical ventilation

    through study completion, an average of 2 weeks

  • 6 Minutes Walking Distance Test (6MWD)

    Change from baseline 6MWD test at day 7，day 14

  • +3 more secondary outcomes

Study Arms (2)

Supine Daoyin

EXPERIMENTAL

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.

Other: Supine Daoyin

Control

ACTIVE COMPARATOR

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

Other: western medicine conventional therapy

Interventions

Supine DaoyinOTHER

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

Supine Daoyin
western medicine conventional therapyOTHER

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

Control

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Patients with severe cognitive impairment, dementia and various psychosis.
  • Combined with severe arthritis and other osteoarthritis affecting the movement.
  • Dyskinesia due to neuromuscular diseases.
  • Long term bedridden for various reasons.
  • Participating in other trials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Henan University of Chinese

Zhengzhou, Henan, 450003, China

RECRUITING

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

  • Li jiansheng, doctor

    The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

    STUDY CHAIR

Central Study Contacts

Zhang hailong, doctor

CONTACT

+86 371 66248624zhanghailong6@126.com

Li jiansheng, doctor

CONTACT

Study Design

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

Study Record Dates

First Submitted

April 26, 2021

First Posted

June 4, 2021

Study Start

March 1, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

January 4, 2022

Record last verified: 2022-01

Locations

CN(1)