Cardiopulmonary Rehabilitation in Post-acute COVID-19 Syndrome

NCT05539950 | Withdrawn

• 1 other identifier: TMU-IJRB-N202208050
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Acute COVID-19 Syndrome

Keywords

Long COVID; Cardiopulmonary rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Week 12

Secondary Outcomes (3)

• Changes in 6 minutes walking test (6MWT)

  Baseline, Week 12

• Changes in Pulmonary function test (PFT)

  Baseline, Week 12

• Changes in 36-Item Short Form Survey (SF-36)

  Baseline, Week 12

Study Arms (2)

Cardiopulmonary rehabilitation with health education

EXPERIMENTAL

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

Health education

ACTIVE COMPARATOR

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

Other: Health education

Interventions

Cardiopulmonary rehabilitation OTHER

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).

Cardiopulmonary rehabilitation with health education

Health education OTHER

Individualized exercise prescription will be given according to their results of the cardiopulmonary Exercise Testing (CPET). Recommendations for lifestyle modification will also be given.

Cardiopulmonary rehabilitation with health education; Health education

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (1)

Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare

Taipei, 235, Taiwan

Location

Related Publications (4)

• 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.

  PMID: 17989266 BACKGROUND

• 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.

  PMID: 1593914 BACKGROUND

• 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.

  PMID: 31689414 BACKGROUND

• 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/

  PMID: 29493964 BACKGROUND

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Attending Physician

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 14, 2022
• Study Start: October 1, 2022
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)