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

Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology

Status: Enrolling

Conditions: Cerebrovascular Diseases; Cardiovascular Diseases; Respiratory Diseases

Treatments: Other: The Routine Care (Non-Pharmacological and Pharmacological Treatments ) Group; Combination Product: Pulmonary Rehabilitation Care Group

Study type: Interventional

Funder types: Other

Identifiers

NCT07090200

XHJY-Chronic disease

2023ZD0509905 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50,000 participants in 2 patient groups

COPD Pulmonary Rehabilitation Care Group

Experimental group

Description:

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.

Treatment:

Combination Product: Pulmonary Rehabilitation Care Group

COPD Routine Care and Sham Comparator Group

Sham Comparator group

Description:

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.

Treatment:

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