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AzTrials

COVID-19NCT05205460

Telerehabilitation in People With Long COVID

A study testing Home-based telerehabilitation and Education and self-exercise in people with COVID-19, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of our study is to investigate the effectiveness of telerehabilitation in Post-COVID patients. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
COVID-19
What is being tested?
Home-based telerehabilitation and Education and self-exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
182 participants
Where
1 siteTaiwan
Study dates
12 Oct 2021to 20 May 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • Tri-service general hospital

    Taipei, Neihu, 11490

Other trials in Taiwan

About this study

Official title: Effectiveness of a 12-week Telerehabilitation Training in People With Long COVID: A Randomized Controlled Trial

The aim of our study is to investigate the effectiveness of telerehabilitation in Post-COVID patients.

Read the 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.

Conditions
COVID-19
Being tested
Home-based telerehabilitation, Education and self-exercise
Keywords
Post-COVID, Telerehabilitation
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Home-based telerehabilitationDevice

    A home-based exercise mobile app will be offered combined with the heart rate sensing clothes to each participant in the group of home-based telehealth exercise training program. The mobile app provides auto-feedback of heart rate at each exercise training session through the heart rate sensing clothes and alarm function identifying individuals' appropriate exercise intensity (target heart rate) during their exercise based on their exercise prescription calculated and set up inside the app. After completing each exercise training session, the record of training time and heart rate response is simultaneously uploaded to the cloud system of the medical center through the heart rate sensing clothes. The experienced and well-trained nurse checked the cloud system data to monitor participants' adherence to exercise training. In addition, online communication is enabled using LINE software, which provided a platform for patients and researchers to interact with each other through messaging.

  • Education and self-exerciseBehavioural

    The participants will receive a exercise prescription suggestion. Then, they will maintain their usual lifestyles without exercise reminders.

Study groups in NCT05205460
Study groupRoleWhat they receive
Home-based telerehabilitationExperimentalAfter graded exercise testing, the participants will receive a single, individual, face-to-face physical activity promotion counseling session (15-20minutes). Then, the participants will start a home-based telehealth exercise training program (30minutes/session, 3 sessions/week for 12weeks, with a total of 36 sessions) combined with heart rate sensing clothes. Exercise type: brisk walking, jogging, or stationary ergometer exercise.
Receives: Device: Home-based telerehabilitation
Education and self-exerciseActive comparatorAfter graded exercise testing, the participants will receive a single, individual, face-to-face physical activity promotion counseling session (15-20minutes). Then, the patients will maintain their usual lifestyles for 12 weeks without exercise reminders.
Receives: Behavioral: Education and self-exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Exercise Capacity: Peak Oxygen Uptake (VO2peak) From Baseline to 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.

    Measured: Baseline, 12 weeks

  2. Change in Exercise Capacity: Workload (Watt) From Baseline to 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.

    Measured: baseline, 12 weeks

  3. Change in Exercise Capacity: Anaerobic Threshold (AT) From Baseline to 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.

    Measured: baseline, 12 weeks

  4. Change in Lung Function: Forced Expiratory Volume 1 (FEV1) From Baseline to 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.

    Measured: baseline, 12 weeks

  5. Change in Lung Function: Forced Vital Capacity (FVC) From Baseline to 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.

    Measured: baseline, 12 weeks

  6. Change in Lung Function: FEV1/FVC % From Baseline to 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.

    Measured: baseline, 12 weeks

  7. Change in Ventilation/ Perfusion Abnormalities (VE/VCO2) From Baseline to 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.

    Measured: baseline, 12 weeks

  8. Change in Left Ventricular Function: O2 Pulse From Baseline to 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.

    Measured: baseline, 12 weeks

  9. Change in Heart Rate Recovery From Baseline to 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.

    Measured: baseline, 12 weeks

Secondary outcomes (4)
  1. Change in Physical Activity Amounts: Taiwan Version of the International Physical Activity Questionnaire From Baseline to 12 Weeks

    Taiwan version of the International Physical Activity Questionnaire. The overall physical activity (MET-min/week), vigorous intensity physical activity (MET-min/week), moderate intensity physical activity (MET-min/week), walking (MET-min/week) are measured.

    Measured: baseline, 12 weeks

  2. Change in Confidence Level of Exercise: Questionnaire of Self-Efficacy Items From Baseline to 12 Weeks

    Questionnaire of Self-Efficacy Items. A five-item self-efficacy measure designed to measure confidence in one's ability to persist with exercising in various situations was developed. A five-point scale is used to rate each item : 1 indicates "not at all confident", 2 indicates "little confident" , 3 indicates "confident", 4 indicates "very confident", 5 indicates "strongly confident".

    Measured: baseline, 12 weeks

  3. Change in Health-Related Quality of Life: Taiwan Version of World Health Organization Quality-of-Life Questionnaire From Baseline to 12 Weeks (WHOQOL-BREF)

    The Taiwanese version of the WHO Quality of Life-BREF (WHOQOL-BREF) with good validity and reliability includes the globally standardized WHOQOL-BREF with 26 items and an additional two locally developed items, making a total of 28 items. It consists of two single-facet items measuring overall quality of life and general health and four domains, including physical (7 items), psychological (6 items), social (4 items), and environmental (9 items) domains. The two additional items are being respected/accepted facet in the social domain and eating/food facet in the environment domain, respectively. The participants rated all items on a scale of 1-5, with higher scores reflecting a greater quality of life. Domain scores were derived by multiplying the mean of the facet scores within each domain by a scaling factor of 4, resulting in potential domain scores ranging from 4 to 20.

    Measured: baseline, 12 weeks

  4. Change in Sleep Quality: Pittsburgh Sleep Quality Index (PSQI) From Baseline to 12 Weeks

    Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a l-month time interval. Nineteen individual items generate seven "component" scores and the sum of scores for these seven components yields one global score. (Scores ranged from 0 to 21, with higher scores indicating poor sleep quality.)

    Measured: baseline, 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2022
  2. Study start12 Oct 2021
  3. Primary completion30 Apr 2023
  4. Study completion20 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
182 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05205460
Sponsor's protocol ID
A202105159
Status last verified
Feb 2025
First submitted
24 Jan 2022
Last updated
11 Mar 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lai CY, Lin CH, Chao TC, Lin CH, Chang CC, Huang CY, Chiang SL. Effectiveness of a 12-week telerehabilitation training in people with long COVID: A randomized controlled trial. Ann Phys Rehabil Med. 2024 Jun;67(5):101853. doi: 10.1016/j.rehab.2024.101853. Epub 2024 Jun 1.

    PubMed 38824899

Questions about this trial

What is this clinical trial studying?

A study testing Home-based telerehabilitation and Education and self-exercise in people with COVID-19, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Exercise Capacity: Peak Oxygen Uptake (VO2peak) From Baseline to 12 Weeks (time frame: Baseline, 12 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05205460, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.

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