Rehabilitation Intervention for COPD Combined With Cardiovascular and Cerebrovascular Diseases (RI-COPD & CCD)

July 18, 2025 updated by: Yang Jin, Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Combination product: 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.
Sham Comparator: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The proportion of high-risk and diagnosed individuals with COPD
Time Frame: through study completion, an average of 4 year
We conducted a cross-sectional screening among a total of 50,000 people, and then calculated the proportion of the high-risk and confirmed COPD patients among the total population. We use COPD questionnaire to screen COPD high-risk groups and make a diagnosis of COPD through pulmonary function test.
through study completion, an average of 4 year
the improvement of acute exacerbation frequency (times/year/person)
Time Frame: through study completion, an average of 4 year
Observe the changes in the improvement of acute exacerbation frequency (times/year/person) after intervention
through study completion, an average of 4 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: through study completion, an average of 4 year
Based on a comprehensive assessment of the patient's blood pressure, blood sugar, blood lipids, etc., the risk of chronic cardiovascular and cerebrovascular diseases was evaluated. All measurements were conducted in accordance with international standards and units （mmHg）
through study completion, an average of 4 year
blood lipids
Time Frame: through study completion, an average of 4 year
The risk of chronic cardiovascular and cerebrovascular diseases was evaluated. based on a comprehensive assessment of the patient's blood pressure, blood sugar, blood lipids, etc.,All measurements were conducted in accordance with international standards and units（mmol/L）.
through study completion, an average of 4 year
FBG(fasting blood-glucose)
Time Frame: through study completion, an average of 4 year
The risk of chronic cardiovascular and cerebrovascular diseases was evaluated. based on a comprehensive assessment of the patient's blood pressure, blood sugar, blood lipids, etc.,All measurements were conducted in accordance with international standards and units（mmol/L）
through study completion, an average of 4 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Observe the changes of SGRQ
Time Frame: through study completion, an average of 4 year
Observe the changes in the improvement of acute exacerbation frequency (times/year/person) after intervention.
through study completion, an average of 4 year
Observe the changes in CAT Scoring
Time Frame: through study completion, an average of 4 year
Observe the changes in CAT Scoring after intervention
through study completion, an average of 4 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XHJY-Chronic disease
  • 2023ZD0509905 (Other Grant/Funding Number: Research on major national science and technology projects)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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