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NCT Number: NCT07154355

Community Exercise Treating Effect on Cardiopulmonary Disease Patients

The goal of this clinical trial is to learn if community-based exercise training can benefit patients aged 18 to 85 with diminished cardiovascular and pulmonary function. The main aim of this study is:

• Establish a community or home-based fitness training program for patients with cardiopulmonary insufficiency to improve adherence, safety, and efficacy while alleviating the burden on both patients and society.

Researchers will compare community-based exercise training to non-exercise training to see if community-based exercise training works to improve cardiovascular and pulmonary function.

Participants will:

* Engage in community or home exercise training for 40-60 minutes, five times weekly, during a duration of eight weeks. Exercise modalities are primarily determined by the patients' individual preferences and habits, such as brisk walking, running, swimming, cycling, and hiking. * Adjust the exercise intensity according to their cardiopulmonary exercise test and the person's perceived exertion level. * Utilize fitness bracelets or watches to document statistics during workouts and submit them to the experimenter weekly, covering the five days of exercise within that week. * refrain from making any dietary modifications throughout the trial.

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Key information

Conditions

Coronary Heart Disease (CHD) Asthma Bronchial Asthma Bronchial Diseases COPD Cardiomyopathies Cardiomyopathy Cardiopulmonary Diseases Cardiovascular Diseases Chronic Disease Coronary Disease Disease Attributes Heart Diseases Heart Failure Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Pulmonary Heart Disease Respiration Disorders Respiratory Failure Respiratory Hypersensitivity Respiratory Insufficiency Respiratory Tract Diseases Thoracic Tumors Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Rehabilitation Medicine Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences)

Guangzhou, Guangdong, 510080, China

Location status: Recruiting

Location contact

Bin Zeng

CONTACT

[email protected]

86-020-83827812

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged 18 to 85 with abnormal pulmonary or cardiovascular function.
  • Individuals who have completed a medical screening form to confirm they are free from illnesses and prescription medications that could impair their ability to complete the required testing and fitness training.
  • Participants who did not engage in structured, systematic moderate-to-intense strength or endurance training during the study period (specifically, not within the previous year).
  • At the onset of the trial, participants were physically active but had never participated in formal exercise more than twice a week.

Exclusion criteria

  • Patients with neuromuscular or skeletal disorders, or systemic diseases such as diabetes, cancer, or heart disease.
  • Individuals using medications known to affect health or the interpretation of study results.
  • Participants who have engaged in organized, systematic endurance or strength training of moderate to high intensity within the past year.
  • Patients who decline to participate in the study.
  • Other medical conditions or states that render exercise training inappropriate.

Treatment and study plan

community-based exercise training

Behavioral

The patients will engage in 40-60 minutes of exercise training, either at home or in the community, five times a week, for eight weeks. Brisk walking, jogging, swimming, cycling, and trekking were among the exercise modalities that were chosen mostly based on the patient's individual preferences and habits. To guarantee safe and efficient exercise, exercise intensity was modified based on each person's subjective effort level and the results of their individual cardiorespiratory exercise tests.

Primary outcomes

  1. exercise capacity

    Time frame: at enrollment and week 8

    Peak oxygen uptake (peakVO₂, ml/(kg·min)), measured by cardiopulmonary exercise testing (CPET), refers to the maximum rate of oxygen consumption per unit time during exhaustive incremental exercise. It serves as a key indicator of cardiopulmonary function and aerobic metabolic capacity.

  2. exercise capacity

    Time frame: at enrollment and week 8

    Anaerobic Threshold (AT, mmol/L) is a key physiological parameter in cardiopulmonary exercise testing (CPET), representing the transition point from predominantly aerobic to anaerobic metabolism during incremental exercise. It is determined by measuring blood lactate concentration through serial blood sampling and plotting the lactate-exercise intensity curve.

  3. life quality

    Time frame: at enrollment and week 8

    The Short Form-36 Health Survey (SF-36) was administered, with scores ranging from 0 to 100 across its eight subscales. Higher scores reflect superior health-related quality of life (HRQoL).

Secondary outcomes

  1. Other exercise capacity outcome

    Time frame: at enrollment and week 8

    Exercise time

  2. Other exercise capacity outcome

    Time frame: at enrollment and week 8

    The 6-minute walk distance (6MWD, m) , obtained through the 6-minute walk test (6MWT), refers to the maximum distance a patient can walk at their fastest pace on a flat, hard surface within 6 minutes. It is used to evaluate an individual's functional exercise capacity and cardiopulmonary endurance.

  3. Other exercise capacity outcome

    Time frame: at enrollment and week 8

    Ventilatory anaerobic threshold (VAT, mL/(kg·min)) , a key physiological parameter in cardiopulmonary exercise testing (CPET), is determined by synchronously monitoring ventilatory parameters during incremental exercise (treadmill/cycle ergometer) and plotting the ventilation-intensity curve. It marks the transition point from predominantly aerobic to anaerobic metabolism during graded exercise.

  4. Other exercise capacity outcome

    Time frame: at enrollment and week 8

    Ventilation/carbon dioxide (VE/VCO₂, mL/(kg·min)) slope, a key parameter for assessing ventilatory efficiency in cardiopulmonary exercise testing (CPET), is defined as the linear regression slope of minute ventilation (VE) against carbon dioxide output (VCO₂), reflecting the volume of ventilation required to eliminate 1 liter of CO₂ during exercise.

  5. Leg strength

    Time frame: at enrollment and week 8

    The Nottingham strength test device is used to assess lower limb muscle strength, with a focus on measuring leg extensor power. By calculating the ratio of power output to body weight (power/weight), it indirectly reflects muscle functional status.

  6. cardiac function

    Time frame: at enrollment and week 8

    Left ventricular ejection fraction (LVEF, %), measured by Doppler echocardiography, is used to assess left ventricular systolic function, representing the percentage of blood pumped out per heartbeat relative to the left ventricular end-diastolic volume.

  7. Blood indices

    Time frame: at enrollment and week 8

    B-type natriuretic peptide (BNP, pg/mL), a key biomarker for heart failure, is used in the diagnosis and therapeutic monitoring of cardiovascular diseases such as heart failure.

  8. Blood indices

    Time frame: at enrollment and week 8

    High-sensitivity C-reactive protein (hsCRP, mg/L) , an inflammatory biomarker measured by high-sensitivity detection technology, is used for cardiovascular disease risk assessment, infection monitoring, and chronic inflammation evaluation.

  9. Blood indices

    Time frame: at enrollment and week 8

    Plasma interleukin-6 (IL-6, pg/mL) levels, a multifunctional proinflammatory cytokine, are used to assess systemic inflammation levels

Study contacts

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

Bin Zeng

CONTACT

[email protected]

13538716788

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Registry information

Official study title

Clinical Study Protocol on the Impact of Community-Based Exercise Training on the Exercise Capacity of Patients With Reduced Cardiovascular and Pulmonary Function

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Sep 4, 2025
Registry last updated
Sep 4, 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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