Coronary Heart Disease (CHD)NCT07154355
Community Exercise Treating Effect on Cardiopulmonary Disease Patients
A study testing community-based exercise training in people with Coronary Heart Disease (CHD) and Heart Failure, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Heart Disease (CHD), Heart Failure, Cardiomyopathy
- What is being tested?
- community-based exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2025to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Rehabilitation Medicine Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences)
Guangzhou, Guangdong, 510080
Bin Zeng, 86-020-83827812, zengbin@gdph.org.cn
About this study
Official title: Clinical Study Protocol on the Impact of Community-Based Exercise Training on the Exercise Capacity of Patients With Reduced Cardiovascular and Pulmonary Function
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.
Read more
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.
- Conditions
- Coronary Heart Disease (CHD), Heart Failure, Cardiomyopathy, COPD, Bronchial Asthma, Respiratory Failure
- Being tested
- community-based exercise training
- Medical subject headings
- Coronary Disease, Heart Failure, Cardiomyopathies, Pulmonary Disease, Chronic Obstructive, Asthma, Respiratory Insufficiency, Pulmonary Heart Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
community-based exercise trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| community-based exercise group | Experimental | Not described |
| non-exercise group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
exercise capacity
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.
Measured: at enrollment and week 8
exercise capacity
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.
Measured: at enrollment and week 8
life quality
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).
Measured: at enrollment and week 8
Secondary outcomes (9)
Other exercise capacity outcome
Exercise time
Measured: at enrollment and week 8
Other exercise capacity outcome
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.
Measured: at enrollment and week 8
Other exercise capacity outcome
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.
Measured: at enrollment and week 8
Other exercise capacity outcome
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.
Measured: at enrollment and week 8
Leg strength
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.
Measured: at enrollment and week 8
cardiac function
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.
Measured: at enrollment and week 8
Blood indices
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.
Measured: at enrollment and week 8
Blood indices
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.
Measured: at enrollment and week 8
Blood indices
Plasma interleukin-6 (IL-6, pg/mL) levels, a multifunctional proinflammatory cytokine, are used to assess systemic inflammation levels
Measured: at enrollment and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start30 Jan 2025
- Primary completionDec 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart Disease (CHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154355
- Sponsor's protocol ID
- 2024-148
- Status last verified
- Jan 2025
- First submitted
- 25 Jan 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Hawley-Hague H, Horne M, Campbell M, Demack S, Skelton DA, Todd C. Multiple levels of influence on older adults' attendance and adherence to community exercise classes. Gerontologist. 2014 Aug;54(4):599-610. doi: 10.1093/geront/gnt075. Epub 2013 Jul 30.
PubMed 23899623Farrance C, Tsofliou F, Clark C. Adherence to community based group exercise interventions for older people: A mixed-methods systematic review. Prev Med. 2016 Jun;87:155-166. doi: 10.1016/j.ypmed.2016.02.037. Epub 2016 Feb 24.
PubMed 26921655Salmon P. Effects of physical exercise on anxiety, depression, and sensitivity to stress: a unifying theory. Clin Psychol Rev. 2001 Feb;21(1):33-61. doi: 10.1016/s0272-7358(99)00032-x.
PubMed 11148895Bashi N, Karunanithi M, Fatehi F, Ding H, Walters D. Remote Monitoring of Patients With Heart Failure: An Overview of Systematic Reviews. J Med Internet Res. 2017 Jan 20;19(1):e18. doi: 10.2196/jmir.6571.
PubMed 28108430Peek K, Sanson-Fisher R, Mackenzie L, Carey M. Interventions to aid patient adherence to physiotherapist prescribed self-management strategies: a systematic review. Physiotherapy. 2016 Jun;102(2):127-35. doi: 10.1016/j.physio.2015.10.003. Epub 2015 Oct 22.
PubMed 26821954Boggenpoel BY, Nel S, Hanekom S. The use of periodized exercise prescription in rehabilitation: a systematic scoping review of literature. Clin Rehabil. 2018 Sep;32(9):1235-1248. doi: 10.1177/0269215518769445. Epub 2018 Apr 17.
PubMed 29663831Jack K, McLean SM, Moffett JK, Gardiner E. Barriers to treatment adherence in physiotherapy outpatient clinics: a systematic review. Man Ther. 2010 Jun;15(3):220-8. doi: 10.1016/j.math.2009.12.004. Epub 2010 Feb 16.
PubMed 20163979O'Regan A, Pollock M, D'Sa S, Niranjan V. ABC of prescribing exercise as medicine: a narrative review of the experiences of general practitioners and patients. BMJ Open Sport Exerc Med. 2021 Jun 2;7(2):e001050. doi: 10.1136/bmjsem-2021-001050. eCollection 2021.
PubMed 34150320Oja P. Dose response between total volume of physical activity and health and fitness. Med Sci Sports Exerc. 2001 Jun;33(6 Suppl):S428-37; discussion S452-3. doi: 10.1097/00005768-200106001-00011.
PubMed 11427767Jakicic JM, Davis KK. Obesity and physical activity. Psychiatr Clin North Am. 2011 Dec;34(4):829-40. doi: 10.1016/j.psc.2011.08.009. Epub 2011 Oct 15.
PubMed 22098807Kehat I, Molkentin JD. Molecular pathways underlying cardiac remodeling during pathophysiological stimulation. Circulation. 2010 Dec 21;122(25):2727-35. doi: 10.1161/CIRCULATIONAHA.110.942268. No abstract available.
PubMed 21173361Kandola AA, Osborn DPJ, Stubbs B, Choi KW, Hayes JF. Individual and combined associations between cardiorespiratory fitness and grip strength with common mental disorders: a prospective cohort study in the UK Biobank. BMC Med. 2020 Nov 11;18(1):303. doi: 10.1186/s12916-020-01782-9.
PubMed 33172457Morkane CM, Kearney O, Bruce DA, Melikian CN, Martin DS. An Outpatient Hospital-based Exercise Training Program for Patients With Cirrhotic Liver Disease Awaiting Transplantation: A Feasibility Trial. Transplantation. 2020 Jan;104(1):97-103. doi: 10.1097/TP.0000000000002803.
PubMed 31205265Tutor A, Lavie CJ, Kachur S, Dinshaw H, Milani RV. Impact of cardiorespiratory fitness on outcomes in cardiac rehabilitation. Prog Cardiovasc Dis. 2022 Jan-Feb;70:2-7. doi: 10.1016/j.pcad.2021.11.001. Epub 2021 Nov 12.
PubMed 34780726Schmid D, Leitzmann MF. Cardiorespiratory fitness as predictor of cancer mortality: a systematic review and meta-analysis. Ann Oncol. 2015 Feb;26(2):272-8. doi: 10.1093/annonc/mdu250. Epub 2014 Jul 9.
PubMed 25009011
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Protocol on the Impact of Community-Based Exercise Training on the Exercise Capacity of Patients With Reduced Cardiovascular and Pulmonary Function
- ClinicalTrials.gov ID
- NCT07154355
- Acronym / sponsor ID
- 2024-148
- Conditions
- Coronary Heart Disease (CHD), Heart Failure, Cardiomyopathy, COPD, Bronchial Asthma, Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| community-based exercise group | Experimental | – |
| non-exercise group | No intervention | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| community-based exercise trainingThe 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. | Behavioural | – |
Primary outcome
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.
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.
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).
9 secondary outcomes
Other exercise capacity outcome
Time frame: at enrollment and week 8
Other exercise capacity outcome
Time frame: at enrollment and week 8
Other exercise capacity outcome
Time frame: at enrollment and week 8
Other exercise capacity outcome
Time frame: at enrollment and week 8
Leg strength
Time frame: at enrollment and week 8
cardiac function
Time frame: at enrollment and week 8
Blood indices
Time frame: at enrollment and week 8
Blood indices
Time frame: at enrollment and week 8
Blood indices
Time frame: at enrollment and week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Background: PubMed 23899623Hawley-Hague H, Horne M, Campbell M, Demack S, Skelton DA, Todd C. Multiple levels of influence on older adults' attendance and adherence to community exercise classes. Gerontologist. 2014 Aug;54(4):599-610. doi: 10.1093/geront/gnt075. Epub 2013 Jul 30.
- Background: PubMed 26921655Farrance C, Tsofliou F, Clark C. Adherence to community based group exercise interventions for older people: A mixed-methods systematic review. Prev Med. 2016 Jun;87:155-166. doi: 10.1016/j.ypmed.2016.02.037. Epub 2016 Feb 24.
- Background: PubMed 11148895Salmon P. Effects of physical exercise on anxiety, depression, and sensitivity to stress: a unifying theory. Clin Psychol Rev. 2001 Feb;21(1):33-61. doi: 10.1016/s0272-7358(99)00032-x.
- Background: PubMed 28108430Bashi N, Karunanithi M, Fatehi F, Ding H, Walters D. Remote Monitoring of Patients With Heart Failure: An Overview of Systematic Reviews. J Med Internet Res. 2017 Jan 20;19(1):e18. doi: 10.2196/jmir.6571.
- Background: PubMed 26821954Peek K, Sanson-Fisher R, Mackenzie L, Carey M. Interventions to aid patient adherence to physiotherapist prescribed self-management strategies: a systematic review. Physiotherapy. 2016 Jun;102(2):127-35. doi: 10.1016/j.physio.2015.10.003. Epub 2015 Oct 22.
- Background: PubMed 29663831Boggenpoel BY, Nel S, Hanekom S. The use of periodized exercise prescription in rehabilitation: a systematic scoping review of literature. Clin Rehabil. 2018 Sep;32(9):1235-1248. doi: 10.1177/0269215518769445. Epub 2018 Apr 17.
- Background: PubMed 20163979Jack K, McLean SM, Moffett JK, Gardiner E. Barriers to treatment adherence in physiotherapy outpatient clinics: a systematic review. Man Ther. 2010 Jun;15(3):220-8. doi: 10.1016/j.math.2009.12.004. Epub 2010 Feb 16.
- Background: PubMed 34150320O'Regan A, Pollock M, D'Sa S, Niranjan V. ABC of prescribing exercise as medicine: a narrative review of the experiences of general practitioners and patients. BMJ Open Sport Exerc Med. 2021 Jun 2;7(2):e001050. doi: 10.1136/bmjsem-2021-001050. eCollection 2021.
- Background: PubMed 11427767Oja P. Dose response between total volume of physical activity and health and fitness. Med Sci Sports Exerc. 2001 Jun;33(6 Suppl):S428-37; discussion S452-3. doi: 10.1097/00005768-200106001-00011.
- Background: PubMed 22098807Jakicic JM, Davis KK. Obesity and physical activity. Psychiatr Clin North Am. 2011 Dec;34(4):829-40. doi: 10.1016/j.psc.2011.08.009. Epub 2011 Oct 15.
- Background: PubMed 21173361Kehat I, Molkentin JD. Molecular pathways underlying cardiac remodeling during pathophysiological stimulation. Circulation. 2010 Dec 21;122(25):2727-35. doi: 10.1161/CIRCULATIONAHA.110.942268. No abstract available.
- Background: PubMed 33172457Kandola AA, Osborn DPJ, Stubbs B, Choi KW, Hayes JF. Individual and combined associations between cardiorespiratory fitness and grip strength with common mental disorders: a prospective cohort study in the UK Biobank. BMC Med. 2020 Nov 11;18(1):303. doi: 10.1186/s12916-020-01782-9.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing community-based exercise training in people with Coronary Heart Disease (CHD) and Heart Failure, run by Guangdong Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bin Zeng (13538716788, zengbin@gdph.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
exercise capacity (time frame: at enrollment and week 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07154355, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.