Clinical trial NCT05539950: Cardiopulmonary Rehabilitation in Post-acute COVID-19 Syndrome
Official title: Cardiopulmonary Rehabilitation in Post-acute COVID-19 Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Post Acute COVID-19 Syndrome
Keywords: Long COVID
Cardiopulmonary rehabilitation
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* be willing and able to provide written informed consent and comply with all procedures required by the protocol
* be 20 - 80 years of age at the time of signing the Informed Consent Form
* diagnosed with COVID-19 with PCR and admitted with at least moderate COVID-19 disease (with clinical symptoms or imaging evidence of low respiratory tract involvement)
* diagnosed with COVID-19 for over 4 weeks but less than 2 years with fatigue, shortness of breath, cough, weakness, or impairments of activities of daily life
* able to cooperate with the rehabilitation programs and cycling

Exclusion Criteria:

* Patients under 20-year-old or over 80-year-old, pregnant, prisoners
* Patients without national health insurance in Taiwan
* The patient cannot follow instructions or cycling

Primary outcomes:
measure: Changes in Cardiopulmonary exercise testing (CPET)
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Changes in 6 minutes walking test (6MWT)
timeFrame: Baseline, Week 12
measure: Changes in Pulmonary function test (PFT)
timeFrame: Baseline, Week 12
measure: Changes in 36-Item Short Form Survey (SF-36)
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare
Study officials:
References:
citation: Albouaini K, Egred M, Alahmar A, Wright DJ. Cardiopulmonary exercise testing and its application. Postgrad Med J. 2007 Nov;83(985):675-82. doi: 10.1136/hrt.2007.121558.
citation: Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
citation: Agarwala P, Salzman SH. Six-Minute Walk Test: Clinical Role, Technique, Coding, and Reimbursement. Chest. 2020 Mar;157(3):603-611. doi: 10.1016/j.chest.2019.10.014. Epub 2019 Nov 2.
citation: Ponce MC, Sankari A, Sharma S. Pulmonary Function Tests. 2023 Aug 28. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482339/