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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| community-based exercise group | Experimental | ||
| non-exercise group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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). | at enrollment and week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Other exercise capacity outcome | Exercise time | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bin Zeng | Contact | 13538716788 | zengbin@gdph.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Rehabilitation Medicine Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences) | Recruiting | Guangzhou | Guangdong | 510080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23899623 | Background | 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. | |
| 26921655 | Background | Farrance 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. |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006333 | Heart Failure |
| D009202 | Cardiomyopathies |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001249 | Asthma |
| D012131 | Respiratory Insufficiency |
| D011660 | Pulmonary Heart Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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 | at enrollment and week 8 |
| 11148895 | Background | Salmon 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. |
| 28108430 | Background | Bashi 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. |
| 26821954 | Background | Peek 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. |
| 29663831 | Background | Boggenpoel 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. |
| 20163979 | Background | Jack 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. |
| 34150320 | Background | O'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. |
| 11427767 | Background | Oja 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. |
| 22098807 | Background | Jakicic 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. |
| 21173361 | Background | Kehat 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. |
| 33172457 | Background | Kandola 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. |
| 31205265 | Background | Morkane 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. |
| 34780726 | Background | Tutor 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. |
| 25009011 | Background | Schmid 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. |
| 19454641 | Background | Kodama S, Saito K, Tanaka S, Maki M, Yachi Y, Asumi M, Sugawara A, Totsuka K, Shimano H, Ohashi Y, Yamada N, Sone H. Cardiorespiratory fitness as a quantitative predictor of all-cause mortality and cardiovascular events in healthy men and women: a meta-analysis. JAMA. 2009 May 20;301(19):2024-35. doi: 10.1001/jama.2009.681. |
| 26606383 | Background | Pedersen BK, Saltin B. Exercise as medicine - evidence for prescribing exercise as therapy in 26 different chronic diseases. Scand J Med Sci Sports. 2015 Dec;25 Suppl 3:1-72. doi: 10.1111/sms.12581. |
| 34437054 | Background | Powell TA, Mysliwiec V, Brock MS, Morris MJ. OSA and cardiorespiratory fitness: a review. J Clin Sleep Med. 2022 Jan 1;18(1):279-288. doi: 10.5664/jcsm.9628. |
| 14600164 | Background | Ferrari AU, Radaelli A, Centola M. Invited review: aging and the cardiovascular system. J Appl Physiol (1985). 2003 Dec;95(6):2591-7. doi: 10.1152/japplphysiol.00601.2003. |
| 31248666 | Background | Zhou M, Wang H, Zeng X, Yin P, Zhu J, Chen W, Li X, Wang L, Wang L, Liu Y, Liu J, Zhang M, Qi J, Yu S, Afshin A, Gakidou E, Glenn S, Krish VS, Miller-Petrie MK, Mountjoy-Venning WC, Mullany EC, Redford SB, Liu H, Naghavi M, Hay SI, Wang L, Murray CJL, Liang X. Mortality, morbidity, and risk factors in China and its provinces, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2019 Sep 28;394(10204):1145-1158. doi: 10.1016/S0140-6736(19)30427-1. Epub 2019 Jun 24. |
| D008173 |
| Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012120 | Respiration Disorders |