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NCT Number: NCT07090200

Rehabilitation Intervention for COPD Combined With Cardiovascular and Cerebrovascular Diseases

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.

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Key information

Conditions

Respiratory Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Diseases Cerebrovascular Disorders Nervous System Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Wuhan, Hubei, 430022, China

Location status: Recruiting

Location contact

Guanzhou Ma

CONTACT

[email protected]

86+13554024801

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Individuals with severe mental illness.
  • 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.
  • Women who are pregnant, breastfeeding, or using inappropriate contraception methods.
  • Individuals who refuse to cooperate with follow-up questionnaires or specimen collection.
  • Patients currently participating in other interventional clinical drug trials.

Treatment and study plan

Pulmonary Rehabilitation Care Group

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.

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

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.

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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）

  2. 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）.

  3. 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）

Other outcomes

  1. 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.

  2. Observe the changes in CAT Scoring

    Time frame: through study completion, an average of 4 year

    Observe the changes in CAT Scoring after intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Guanzhou Ma

CONTACT

[email protected]

86+13554024801

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: RI-COPD & CCD

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 29, 2025
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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