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Cardiopulmonary Rehabilitation in Post-acute COVID-19 Syndrome (COVID-19)

Primary Purpose

Post Acute COVID-19 Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Cardiopulmonary rehabilitation
Health education
Sponsored by
Taipei Medical University Shuang Ho Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Acute COVID-19 Syndrome focused on measuring Long COVID, Cardiopulmonary rehabilitation

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cardiopulmonary rehabilitation with health education

Health education

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
September 12, 2022
Last Updated
September 12, 2022
Sponsor
Taipei Medical University Shuang Ho Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05539950
Brief Title
Cardiopulmonary Rehabilitation in Post-acute COVID-19 Syndrome
Acronym
COVID-19
Official Title
Cardiopulmonary Rehabilitation in Post-acute COVID-19 Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2022 (Anticipated)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University Shuang Ho Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Acute COVID-19 Syndrome
Keywords
Long COVID, Cardiopulmonary rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cardiopulmonary rehabilitation with health education
Arm Type
Experimental
Arm 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.
Arm Title
Health education
Arm Type
Active Comparator
Arm Description
The participants will be given recommendations for individualized exercise prescription and lifestyle modification.
Intervention Type
Other
Intervention Name(s)
Cardiopulmonary rehabilitation
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Health education
Intervention Description
Individualized exercise prescription will be given according to their results of the cardiopulmonary Exercise Testing (CPET). Recommendations for lifestyle modification will also be given.
Primary Outcome Measure Information:
Title
Changes in Cardiopulmonary exercise testing (CPET)
Description
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
Secondary Outcome Measure Information:
Title
Changes in 6 minutes walking test (6MWT)
Description
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
Title
Changes in Pulmonary function test (PFT)
Description
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
Title
Changes in 36-Item Short Form Survey (SF-36)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hung-Chou Chen, MD
Phone
+886 02-22490088
Ext
1630
Email
10462@s.tmu.edu.tw
Facility Information:
Facility Name
Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare
City
Taipei
ZIP/Postal Code
235
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mei-Sean Loh
Phone
+886 02-22490088
Ext
1603
Email
19210@s.tmu.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17989266
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.
Results Reference
background
PubMed Identifier
1593914
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.
Results Reference
background
PubMed Identifier
31689414
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.
Results Reference
background
Citation
Ponce MC, Sharma S. Pulmonary Function Tests. [Updated 2021 Aug 11]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK482339/
Results Reference
background

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Cardiopulmonary Rehabilitation in Post-acute COVID-19 Syndrome

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