An interventional study of Cardiopulmonary rehabilitation and Health education in Post Acute COVID-19 Syndrome, sponsored by Taipei Medical University Shuang Ho Hospital. Withdrawn at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-03-26.
Sponsored by Taipei Medical University Shuang Ho Hospital · Not applicable, Interventional, and Treatment
In 2022, though the optimized acute medical treatment of COVID-19 was determined, patients often experience the sequelae (also known as post-acute COVID-19 syndrome, the patients might develop cough, breathlessness, fatigue, weakness, impaired activities of daily livings etc.). Until now, there is no consensus for post-acute COVID-19 syndrome management. Previously, the cardiopulmonary rehabilitation revealed significant benefits in heart failure or chronic obstructive pulmonary disease. The aims of the study are demonstrating the benefits and safety of cardiopulmonary rehabilitations in patients previously admitted to hospital because of COVID-19 with sequelae.
PURPOSE: To demonstrate the benefits and safety of cardiopulmonary rehabilitations in patients previously admitted to hospital because of COVID-19 with sequelae.
METHODS: The participants will be divided into two groups: one with cardiopulmonary rehabilitations programs under the supervision of therapists 3 times a week, 12 weeks in total with lifestyle modification (experimental group); and the other with lifestyle modification and health education (active-controlled group). Before and after the interventions, several endpoints in interested are performed by the physicians or the research assistants, including cardiopulmonary exercise training (CPET), 6-minute-walk-test (6MWT), pulmonary function tests (PFT), and quality of life (QoL, we plan to use SF-36) questionnaire.
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Exclusion Criteria:
The participants will participate in cardiopulmonary rehabilitations programs under the supervision of therapists 3 times a week, 12 weeks in total. Recommendations for individualized exercise prescription and lifestyle modification will be given to the participants as well.
Other: Cardiopulmonary rehabilitation · Other: Health education
The participants will be given recommendations for individualized exercise prescription and lifestyle modification.
Other: Health education
Cardiopulmonary rehabilitation helps patients maximize functional potential due to progressive deconditioning or acute decompensation following an acute medical event. This intervention is medically supervised and individualized according to their results of the cardiopulmonary Exercise Testing (CPET).
Individualized exercise prescription will be given according to their results of the cardiopulmonary Exercise Testing (CPET). Recommendations for lifestyle modification will also be given.
Changes in Cardiopulmonary exercise testing (CPET)
CPET is a non-invasive examination, which provides assessment of the integrative exercise responses involving the pulmonary, cardiovascular, hematopoietic, neuropsychological, and skeletal muscle systems. It permits the evaluation of both submaximal and peak exercise responses. CPET is currently act as a clinical applications for the evaluation of undiagnosed exercise intolerance and for the objective determination of functional capacity and impairment.
Time frame: Baseline, Week 12
Changes in 6 minutes walking test (6MWT)
6MWT is a commonly used test for the objective assessment of functional exercise capacity for the management of patients with moderate-to-severe pulmonary disease. This test does not require complex equipment or technical expertise. The participant is asked to walk as far as possible along a 30-m minimally trafficked corridor for a period of 6 min with the primary outcome measure being the 6-min walk distance (6MWD) measured in meters.
Time frame: Baseline, Week 12
Changes in Pulmonary function test (PFT)
PFT is used in investigating and monitoring of patients with respiratory pathology. PFT allows physicians to quantify the severity of the pulmonary disease, follow it up over time, and assess its response to treatment.
Time frame: Baseline, Week 12
Changes in 36-Item Short Form Survey (SF-36)
SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. This questionnaire includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions.
Time frame: Baseline, Week 12
Plan to share: No
This study is withdrawn, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Taipei Medical University Shuang Ho Hospital