Cardiopulmonary Rehabilitation in Post-acute COVID-19 Syndrome

Taipei Medical University

Status: Withdrawn

Conditions: Post Acute COVID-19 Syndrome

Treatments: Other: Health education; Other: Cardiopulmonary rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT05539950

TMU-IJRB-N202208050

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Cardiopulmonary rehabilitation with health education

Experimental group

Description:

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.

Treatment:

Other: Cardiopulmonary rehabilitation

Other: Health education

Health education

Active Comparator group

Description:

The participants will be given recommendations for individualized exercise prescription and lifestyle modification.

Treatment:

Other: Health education