Community Exercise Treating Effect on Cardiopulmonary Disease Patients

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

Overview

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.

Interventions

• Behavioral community-based exercise training
  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 outcome measures

• exercise capacity [Time frame: at enrollment and week 8]
• exercise capacity [Time frame: at enrollment and week 8]
• life quality [Time frame: at enrollment and week 8]

Secondary outcome measures (9)

• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• Department of Rehabilitation Medicine Guangdong Provincial People's Hospital (Guangdong Ac — Guangzhou

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. PMID 23899623
• 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. PMID 26921655
• 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. PMID 11148895
• 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. PMID 28108430
• 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. PMID 26821954
• 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. PMID 29663831
• 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. PMID 20163979
• 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. PMID 34150320

Identifiers

NCT: NCT07154355 · 2024-148

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗