- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07553897
Tele-exercise Training Program for Long COVID
Effectiveness of a Tele-Exercise Training Program on Long COVID Symptoms and Quality of Life in Patients With Long COVID
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Long COVID is a multi-organ condition with persistent or delayed symptoms lasting weeks after infection, affecting physical and psychological function and reducing quality of life. It can occur regardless of age or initial disease severity, with prevalence ranging from 30% to 87.4%. Common symptoms include fatigue, cardiopulmonary issues, and neurological problems, collectively impairing daily functioning and mental health.
Exercise-based rehabilitation, including tele-exercise training, has emerged as a practical management strategy and may improve symptoms, cardiorespiratory fitness, and quality of life. However, current evidence remains limited due to small sample sizes and inconsistent protocols. Therefore, this study evaluated the effects of a 12-week tele-exercise program on symptoms, fitness, and quality of life in Taiwanese patients with long COVID compared with usual care.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Neihu
-
Taipei, Neihu, Taiwan, 11490
- Tri-Service General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 20-80 years
- Diagnosed with long COVID based on the criteria of the World Health Organization
- Able to speak and understand Mandarin
- Able to ambulate independently
- Owns a mobile phone with Internet access
- Willing to participate and undergo randomization
Exclusion Criteria:
- History of arrhythmia
- History of mental illness
- Pregnancy
- Acute or unstable chronic diseases (e.g., recent stroke, ongoing cancer treatment, end-stage renal disease requiring dialysis, or major surgery within the previous 3 months) Comorbid neurological or musculoskeletal conditions (e.g., stroke, Parkinson's disease, or dementia) resulting in moderate-to-severe physical disability
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Telehealth exercise training
Telehealth exercise training for 12 weeks
|
Each participant received an individual exercise counselling session lasting 10-15 minutes, based on the guidelines of the American College of Sports Medicine. Participants in the home-based telehealth exercise group were provided with a mobile exercise application integrated with heart rate-monitoring clothing. The app delivers real-time heart rate feedback during each session and includes an alert system to ensure participants maintain their prescribed target heart rate based on individualized exercise prescriptions. Upon completion of each session, exercise duration and heart rate data are automatically uploaded to the medical center's cloud system via the monitoring device. An experienced nurse regularly reviewed the cloud-based data to monitor adherence. Additionally, communication between participants and researchers was facilitated through the LINE platform, enabling timely interaction and support. |
|
Active Comparator: Education and self-exercise
usual outpatient care for 12 weeks
|
Each participant received an individual exercise counselling session lasting 10-15 minutes, based on the guidelines of the American College of Sports Medicine. Participants received usual outpatient care for long COVID, which included general guidance on physical activity, physician-led management of persistent symptoms (e.g., fatigue, dyspnea, and reduced exercise tolerance), and routine follow-up visits as clinically indicated. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Long COVID Symptoms
Time Frame: 12 weeks
|
Common long COVID symptoms, based on the participants' subjective reports, include fatigue, shortness of breath, cough, chest pain, palpitations, brain fog, headaches, sleep disturbances, dizziness, changes in taste or smell, and depression or anxiety; these were assessed by a physician using a checklist with a binary response (present or absent).
|
12 weeks
|
|
Cardiorespiratory Fitness - Peak Oxygen Uptake (VO₂peak)
Time Frame: 12 weeks
|
Participants will undergo cardiopulmonary exercise testing using a motorized cycle ergometer with an incremental ramp protocol (10 W/min). The test will continue until participants report physical exhaustion or reach maximal exercise capacity, defined by respiratory exchange ratio criteria. Peak oxygen uptake (VO₂peak, mL/kg/min) will be estimated from maximal cardiac output and oxygen utilization and identified when oxygen consumption plateaus despite increasing exercise intensity. Unit of Measure: mL/kg/min |
12 weeks
|
|
Cardiorespiratory Fitness - Peak Workload
Time Frame: 12 weeks
|
During cardiopulmonary exercise testing, peak workload (watts) will be recorded as the highest workload achieved on the cycle ergometer. This reflects participants' ability to tolerate increasing exercise intensity. Unit of Measure: watts |
12 weeks
|
|
Cardiorespiratory Fitness - Anaerobic Threshold
Time Frame: 12 weeks
|
Anaerobic threshold (AT, mL/kg/min) will be determined during cardiopulmonary exercise testing as the point at which energy production begins to shift from aerobic to anaerobic metabolism. Unit of Measure: mL/kg/min |
12 weeks
|
|
Health-Related Quality of Life
Time Frame: 12 weeks
|
The brief World Health Organization Quality of Life questionnaire includes 26 standardized items covering four domains: physical, psychological, social, and environmental. It also contains two general items assessing overall quality of life and general health. The Taiwanese version adds two culturally specific items related to social respect/acceptance and eating/food. All items are rated on a 5-point Likert scale, where higher scores reflect better quality of life. Scores for each domain are calculated by averaging the item scores within that domain and then multiplying by 4, yielding a final score range from 4 to 20. |
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Safety and adverse events
Time Frame: 12 weeks
|
Adverse events were monitored throughout the 12-week intervention. They were defined as any unfavorable or unintended signs, symptoms, or medical conditions occurring during the study that were considered related or possibly related to the intervention and required medical attention, discontinuation of exercise, or modification of the intervention. Mild and transient exercise-related responses, such as expected fatigue or delayed-onset muscle soreness that resolved without medical intervention, were not classified as adverse events, in accordance with standard exercise guidelines. |
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shang-Lin Chiang, PhD, Tri-Service General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Post-Infectious Disorders
- COVID-19
- Pathologic Processes
- Chronic Disease
- Disease Attributes
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- Pathological Conditions, Signs and Symptoms
- Post-Acute COVID-19 Syndrome
- Socioeconomic Factors
- Population Characteristics
- Educational Status
Other Study ID Numbers
- A202105159-2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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