Rehabilitation Intervention for COPD Combined With Cardiovascular and Cerebrovascular Diseases

NCT ID: NCT07090200

Last Updated: 2025-07-29

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

RECRUITING

Clinical Phase

NA

Total Enrollment

50000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2028-07-31

Brief Summary

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Firstly, to screen out the high-risk population of COPD combined with cardiovascular and cerebrovascular diseases, COPD with cardiovascular and make a diagnosis. Then, to evaluate the therapeutic effect of Pulmonary rehabilitation exercise and usual care for three months. And finally, to build a trinity model of rehabilitation management of COPD patients. The objective of this project is to establish and promote the application of diagnostic and treatment norms.

Detailed Description

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Firstly, to screen out the high-risk population of COPD combined with cardiovascular and cerebrovascular diseases, COPD with cardiovascular and make a diagnosis. Then, participants were randomized (1:1) to either the optimized or routine group via a computer-generated random number table. The Routine Care Group received treatment for three months and follow-up with medications prescribed according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2025 Report. The Pulmonary Rehabilitation Care Group received the Pulmonary rehabilitation exercise and usual care for three months. Next, Observe the changes in the improvement of acute exacerbation frequency (times/year/person),CAT Scoring and St. George's Respiratory Questionnaire (SGRQ), as well as lung ventilation and diffusion function of the two groups of patients one year after the intervention. And finally, to build a trinity model of rehabilitation management of COPD patients.

Conditions

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Respiratory Diseases Cardiovascular Diseases Cerebrovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Firstly, to screen out the high-risk population of COPD combined with cardiovascular and cerebrovascular diseases, COPD with cardiovascular and make a diagnosis. Then, participants were randomized (1:1) to either the optimized or routine group via a computer-generated random number table. The Routine Care Group received treatment for three months and follow-up with medications prescribed according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2025 Report. The Pulmonary Rehabilitation Care Group received the Pulmonary rehabilitation exercise and usual care for three months. Next, Observe the changes in the improvement of acute exacerbation frequency (times/year/person),CAT Scoring and St. George's Respiratory Questionnaire (SGRQ), as well as lung ventilation and diffusion function of the two groups of patients one year after the intervention. And finally, to build a trinity model of rehabilitation management of COPD patients.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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COPD Pulmonary Rehabilitation Care Group

The Pulmonary Rehabilitation Care Group received the Pulmonary rehabilitation exercise and usual care for three months. Next, Observe the changes in the improvement of acute exacerbation frequency (times/year/person),CAT Scoring and St. George's Respiratory Questionnaire (SGRQ), as well as lung ventilation and diffusion function one year after the intervention.

Group Type EXPERIMENTAL

Pulmonary Rehabilitation Care Group

Intervention Type COMBINATION_PRODUCT

participants were randomized (1:1) to either the optimized or routine group via a computer-generated random number table. The Routine Care Group received treatment for three months and follow-up with medications prescribed according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2025 Report. The Pulmonary Rehabilitation Care Group received the Pulmonary rehabilitation exercise and usual care for three months. Next, Observe the changes in the improvement of acute exacerbation frequency (times/year/person),CAT Scoring and St. George's Respiratory Questionnaire (SGRQ), as well as lung ventilation and diffusion function of the two groups of patients one year after the intervention.

COPD Routine Care and Sham Comparator Group

The Routine Care Group received treatment for three months and follow-up with medications prescribed according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2025 Report. Next, Observe the changes in the improvement of acute exacerbation frequency (times/year/person),CAT Scoring and St. George's Respiratory Questionnaire (SGRQ), as well as lung ventilation and diffusion function of the two groups of patients one year after the intervention.

Group Type SHAM_COMPARATOR

The Routine Care (Non-Pharmacological and Pharmacological Treatments ) Group

Intervention Type OTHER

participants were randomized (1:1) to either the optimized or routine group via a computer-generated random number table. The Routine Care Group received treatment for three months and follow-up with medications prescribed according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2025 Report. Next, Observe the changes in the improvement of acute exacerbation frequency (times/year/person),CAT Scoring and St. George's Respiratory Questionnaire (SGRQ), as well as lung ventilation and diffusion function one year after the intervention.

Interventions

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Pulmonary Rehabilitation Care Group

participants were randomized (1:1) to either the optimized or routine group via a computer-generated random number table. The Routine Care Group received treatment for three months and follow-up with medications prescribed according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2025 Report. The Pulmonary Rehabilitation Care Group received the Pulmonary rehabilitation exercise and usual care for three months. Next, Observe the changes in the improvement of acute exacerbation frequency (times/year/person),CAT Scoring and St. George's Respiratory Questionnaire (SGRQ), as well as lung ventilation and diffusion function of the two groups of patients one year after the intervention.

Intervention Type COMBINATION_PRODUCT

The Routine Care (Non-Pharmacological and Pharmacological Treatments ) Group

participants were randomized (1:1) to either the optimized or routine group via a computer-generated random number table. The Routine Care Group received treatment for three months and follow-up with medications prescribed according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2025 Report. Next, Observe the changes in the improvement of acute exacerbation frequency (times/year/person),CAT Scoring and St. George's Respiratory Questionnaire (SGRQ), as well as lung ventilation and diffusion function one year after the intervention.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Committed to adhering to the study protocol and cooperating with the implementation of the entire research process.
2. Aged 18 years or older, regardless of gender.
3. Signed informed consent form.

Exclusion Criteria

1. Individuals with severe mental illness.
2. Individuals assessed by medical personnel as having a disease that requires immediate hospitalization or a severe, uncontrollable condition that is life-threatening in the short term.
3. Women who are pregnant, breastfeeding, or using inappropriate contraception methods.
4. Individuals who refuse to cooperate with follow-up questionnaires or specimen collection.
5. Patients currently participating in other interventional clinical drug trials.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Yang Jin

Subdecanal,Professor and Director of Respiratory and Critical Care Medicine, Chief Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Union hospital, Tongji Medical college, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Guanzhou Ma

Role: CONTACT

86+13554024801

Facility Contacts

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Guanzhou Ma

Role: primary

86+13554024801

Other Identifiers

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2023ZD0509905

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

XHJY-Chronic disease

Identifier Type: -

Identifier Source: org_study_id

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