Community Exercise Treating Effect on Cardiopulmonary Disease Patients

NCT07154355 | Recruiting

• 1 other identifier: 2024-148
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Coronary Heart Disease (CHD); Heart Failure; Cardiomyopathy; COPD; Bronchial Asthma; Respiratory Failure; Thoracic Tumors; Cardiopulmonary Diseases

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (9)

• Other exercise capacity outcome

  at enrollment and week 8

• Other exercise capacity outcome

  at enrollment and week 8

• Other exercise capacity outcome

  at enrollment and week 8

• Other exercise capacity outcome

  at enrollment and week 8

• Leg strength

  at enrollment and week 8

Study Arms (2)

community-based exercise group

EXPERIMENTAL

non-exercise group

NO INTERVENTION

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510080, China

RECRUITING

Related Publications (20)

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  PMID: 21173361 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.

  PMID: 33172457 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.

  PMID: 31205265 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.

  PMID: 34780726 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.

  PMID: 25009011 BACKGROUND

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• 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.

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• 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.

  PMID: 31248666 BACKGROUND

MeSH Terms

Conditions

Coronary Disease; Heart Failure; Cardiomyopathies; Pulmonary Disease, Chronic Obstructive; Asthma; Respiratory Insufficiency; Pulmonary Heart Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiration Disorders

Central Study Contacts

Bin Zeng

CONTACT

13538716788; zengbin@gdph.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2025
• First Posted: September 4, 2025
• Study Start: January 30, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: September 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)