Effectiveness of a 12-week Telerehabilitation Training in People With Long COVID: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- Tri-Service General Hospital
- Enrollment
- 182
- Locations
- 1
- Primary Endpoint
- Change in Exercise Capacity: Peak Oxygen Uptake (VO2peak) From Baseline to 12 Weeks
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The aim of our study is to investigate the effectiveness of telerehabilitation in Post-COVID patients.
Detailed Description
Decreased exercise capacity, persistent dyspnea and easily fatigue are found in some Post-COVID patients. Telerehabilitation has been developed in cardiac and pulmonary diseases such as coronary artery disease and chronic obstructive pulmonary disease for years with good clinical outcomes. However, little is known about the effectiveness of home-based telerehabilitation among Post-COVID patients. Thus, we want to investigate the effectiveness of telerehabilitation among Post-COVID patients, including cardiorespiratory fitness, physical activity amounts, health related quality of life and sleep quality.
Investigators
Chia-Ying Lai
Doctor
Tri-Service General Hospital
Eligibility Criteria
Inclusion Criteria
- •Individuals who had been diagnosed with COVID-19 positive and whose last PCR test or rapid antigen test was negative with the following criteria:
- •aged between 20 to 80 years old
- •persistent symptoms at least 4 weeks after recovery from COVID-19 infection, including any of the following symptoms: dyspnea, fatigue, cough, headache, chest tightness, palpitations, loss of smell, anxiety, insomnia, brain fog or joint pain
- •able to speak and understand Mandarin
- •able to walk including those who need the walking aid
- •had mobile phones and could easily access the Internet
Exclusion Criteria
- •a history of chronic obstructive pulmonary disease or other respiratory diseases
- •a history of arrhythmia,cancer, end-stage renal disease with dialysis, being diagnosed with mental illness, recent stroke within 6 months
- •inability to participate because of comorbid neurological or musculoskeletal conditions that produce moderate to severe physical disability
- •need all day oxygen support
Outcomes
Primary Outcomes
Change in Exercise Capacity: Peak Oxygen Uptake (VO2peak) From Baseline to 12 Weeks
Time Frame: Baseline, 12 weeks
The peak oxygen uptake (VO2peak) is measured by graded exercise testing. A cycling ergometer (MGC Ultima CardiO2) is used for cardiopulmonary testing with a incremental ramp protocol (10-W/min). The test will be terminated until patients complained of physical exhaustion or maximal capacity (respiratory exchange ratio (RER) meets 1.2). The change in VO2 peak was calculated as the value at 12 weeks minus the value at baseline. A higher VO2 peak indicates better exercise capacity.
Change in Exercise Capacity: Workload (Watt) From Baseline to 12 Weeks
Time Frame: baseline, 12 weeks
The workload (Watt) is measured by graded exercise testing. A cycling ergometer (MGC Ultima CardiO2) is used for cardiopulmonary testing with a incremental ramp protocol (10-W/min). The test will be terminated until patients complained of physical exhaustion or maximal capacity (respiratory exchange ratio (RER) meets 1.2). The change in workload was calculated as the value at 12 weeks minus the value at baseline. A higher workload indicates better exercise capacity.
Change in Exercise Capacity: Anaerobic Threshold (AT) From Baseline to 12 Weeks
Time Frame: baseline, 12 weeks
The anaerobic threshold (AT) is measured by graded exercise testing. A cycling ergometer (MGC Ultima CardiO2) is used for cardiopulmonary testing with a incremental ramp protocol (10-W/min). The test will be terminated until patients complained of physical exhaustion or maximal capacity (respiratory exchange ratio (RER) meets 1.2). The change in AT was calculated as the value at 12 weeks minus the value at baseline. A higher AT indicates better exercise capacity and endurance.
Change in Lung Function: Forced Expiratory Volume 1 (FEV1) From Baseline to 12 Weeks
Time Frame: baseline, 12 weeks
The amount of air exhaled (mL) during the first second during a forced expiratory volume test will be measured by spirometry. The change in FEV₁ was calculated as the value at 12 weeks minus the value at baseline. A higher FEV₁ indicates better lung function.
Change in Lung Function: Forced Vital Capacity (FVC) From Baseline to 12 Weeks
Time Frame: baseline, 12 weeks
The total amount of air exhaled (mL) during a forced expiratory volume test will be measured by spirometry. The change in FVC was calculated as the value at 12 weeks minus the value at baseline. A higher FVC indicates better lung function.
Change in Lung Function: FEV1/FVC % From Baseline to 12 Weeks
Time Frame: baseline, 12 weeks
The measured FEV1 is divided by the measured FVC. he change in FEV₁/FVC was calculated as the value at 12 weeks minus the value at baseline. A higher FEV₁/FVC ratio generally indicates better lung function, while a lower ratio suggests airflow limitation.
Change in Ventilation/ Perfusion Abnormalities (VE/VCO2) From Baseline to 12 Weeks
Time Frame: baseline, 12 weeks
The ventilation/ perfusion abnormalities (VE/VCO2)is measured by graded exercise testing. A cycling ergometer (MGC Ultima CardiO2) is used for cardiopulmonary testing with a incremental ramp protocol (10-W/min). The test will be terminated until patients complained of physical exhaustion or maximal capacity (respiratory exchange ratio (RER) meets 1.2). The change in VE/VCO2 was calculated as the value at 12 weeks minus the value at baseline. A lower VE/VCO2 ratio indicates better ventilatory efficiency and reduced ventilation/perfusion abnormalities.
Change in Left Ventricular Function: O2 Pulse From Baseline to 12 Weeks
Time Frame: baseline, 12 weeks
O2 Pulse is simply oxygen consumption (in ml) divided by heart rate. It is used as an index of stroke volume.The O2 pulse is measured by graded exercise testing. A cycling ergometer (MGC Ultima CardiO2) is used for cardiopulmonary testing with a incremental ramp protocol (10-W/min). The test will be terminated until patients complained of physical exhaustion or maximal capacity (respiratory exchange ratio (RER) meets 1.2). The change in O₂ pulse was calculated as the value at 12 weeks minus the value at baseline. A higher O₂ pulse indicates improved left ventricular function and greater cardiovascular efficiency.
Change in Heart Rate Recovery From Baseline to 12 Weeks
Time Frame: baseline, 12 weeks
The heart rate recovery is measured by graded exercise testing, including 1 minute and 2 minute recovery. A cycling ergometer (MGC Ultima CardiO2) is used for cardiopulmonary testing with a incremental ramp protocol (10-W/min). The test will be terminated until patients complained of physical exhaustion or maximal capacity (respiratory exchange ratio (RER) meets 1.2). The change in heart rate recovery was calculated as the difference between heart rate recovery at 12 weeks and heart rate recovery at baseline. A decrease of \< 12 or 22 beats per minute in 1- or 2-min heart rate recovery, respectively, indicates an elevated risk of mortality. A faster heart rate recovery indicates better cardiovascular fitness and autonomic regulation.
Secondary Outcomes
- Change in Physical Activity Amounts: Taiwan Version of the International Physical Activity Questionnaire From Baseline to 12 Weeks(baseline, 12 weeks)
- Change in Confidence Level of Exercise: Questionnaire of Self-Efficacy Items From Baseline to 12 Weeks(baseline, 12 weeks)
- Change in Health-Related Quality of Life: Taiwan Version of World Health Organization Quality-of-Life Questionnaire From Baseline to 12 Weeks (WHOQOL-BREF)(baseline, 12 weeks)
- Change in Sleep Quality: Pittsburgh Sleep Quality Index (PSQI) From Baseline to 12 Weeks(baseline, 12 weeks)