Rehabilitation Intervention for COPD Combined With Cardiovascular and Cerebrovascular Diseases

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

50,000 Participants
are divided into 2 treatment groups
Group A: COPD Pulmonary Rehabilitation Care GroupExperimental treatment 1 intervention
Group B: COPD Routine Care and Sham Comparator GroupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
through study completion, an average of 4 year
2

the improvement of acute exacerbation frequency (times/year/person)

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

Time frame
through study completion, an average of 4 year

Secondary outcomes

1

Blood pressure

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)

Time frame
through study completion, an average of 4 year
2

blood lipids

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).

Time frame
through study completion, an average of 4 year
3

FBG(fasting blood-glucose)

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)

Time frame
through study completion, an average of 4 year

Other outcomes

1

Observe the changes of SGRQ

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

Time frame
through study completion, an average of 4 year
2

Observe the changes in CAT Scoring

Observe the changes in CAT Scoring after intervention

Time frame
through study completion, an average of 4 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.