Rehabilitation Intervention for COPD Combined With Cardiovascular and Cerebrovascular Diseases

NCT07090200 | Recruiting

• 2 other identifiers: XHJY-Chronic disease2023ZD0509905
• Study Type: interventional
• Target: 50,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Diseases; Cardiovascular Diseases; Cerebrovascular Diseases

Keywords

prevention; treatment strategies; respiratory diseases; cardiovascular diseases; cerebrovascular diseases

Outcome Measures

Primary Outcomes (2)

• The proportion of high-risk and diagnosed individuals with COPD

  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)

  Observe the changes in the improvement of acute exacerbation frequency (times/year/person) after intervention

  through study completion, an average of 4 year

Secondary Outcomes (3)

• Blood pressure

  through study completion, an average of 4 year

• blood lipids

  through study completion, an average of 4 year

• FBG(fasting blood-glucose)

  through study completion, an average of 4 year

Other Outcomes (2)

• Observe the changes of SGRQ

  through study completion, an average of 4 year

• Observe the changes in CAT Scoring

  through study completion, an average of 4 year

Study Arms (2)

COPD Pulmonary Rehabilitation Care Group

EXPERIMENTAL

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

COPD Routine Care and Sham Comparator Group

SHAM COMPARATOR

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

Interventions

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.

COPD Pulmonary Rehabilitation Care Group

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.

COPD Routine Care and Sham Comparator Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Wuhan, Hubei, 430022, China

RECRUITING

MeSH Terms

Conditions

Respiratory Tract Diseases; Cardiovascular Diseases; Cerebrovascular Disorders

Interventions

Drug Therapy; Population Groups

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Demography; Population Characteristics

Central Study Contacts

Guanzhou Ma

CONTACT

86+13554024801; maguanzhouxiehe@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Subdecanal,Professor and Director of Respiratory and Critical Care Medicine, Chief Investigator

Model Details: 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 Record Dates

• First Submitted: May 4, 2025
• First Posted: July 29, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: July 29, 2025

Record last verified: 2025-07

Locations

CN (1)