- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05778344
Teletechnology-assisted Home-based Exercise Program for Severe COVID-19
September 4, 2025 updated by: National Taiwan University Clinical Trial Center, National Taiwan University Hospital
Efficacy of Teletechnology-assisted Home-based Exercise Program for Severe COVID-19
The aim of this study was to investigate the efficacy of a home-based pulmonary rehabilitation program with the support of teletechnology in COVID-19 survivors. The main questions it aims to answer were:
- The change of six-minute walk distance
- The change of time of one-minute sit-to-stand test
- The change of maximal strength of upper-limb, lower-limb and respiratory muscle
- The change of quality of life Participants in the home-based pulmonary rehabilitation group received teletechnology-assisted consultations (either by videotelephony or telephone calls) for every 1-2 weeks during the intervention period, and participants in the usual care group did not receive teletechnology-assisted consultations during the intervention period.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Taipei, Taiwan, 100
- National Taiwan University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients are 20 years or more with severe (severe pneumonia) to critical (acute respiratory distress syndrome, sepsis, or septic shock) COVID-19 during hospitalization after deisolation.
- Patients are 65 years or more, or ever receiving oral antiviral treatment after deisolation.
- Patient have the ability to ambulate on level surface without direct contact of another person, have telecommunication device(s), and provide consent to receive teletechnology-assisted rehabilitation.
Exclusion Criteria:
- Patients are pregnant or planning for pregnancy.
- Patients have cognitive dysfunction, learning disability, uncontrolled arrhythmia or hypertension, or any medical diagnosis other than COVID-19 that would prominently influence their ability to follow instructions and perform exercise.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Usual care group
The usual care group will receive breathing exercise instructions using online learning materials soon after randomization.
The participants will also receive general exercise education and exercise safety principles but not any consultation about their physical activity/exercise during the study period.
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The accuracy and safety of home-based pulmonary rehabilitation will be checked regularly through technology devices such as smart watch and via videotelephony (or telephone calls if indicated).
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Experimental: Home-based pulmonary rehabilitation group
The home-based pulmonary rehabilitation group received breathing exercise instructions using online learning materials soon after randomization.
The participants received a home-based exercise plan, which comprised aerobic exercise and resistance exercise with instruction sheets.
Teletechnology was incorporated into home-based pulmonary rehabilitation via videotelephony (or telephone calls if indicated).
Time points for these teletechnology-assisted consultations were at day 7, day 14 after randomization and every 2 weeks after that until the completion of the study (week 12).
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The accuracy and safety of home-based pulmonary rehabilitation will be checked regularly through technology devices such as smart watch and via videotelephony (or telephone calls if indicated).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Six-minute walk distance
Time Frame: Week 0
|
The distance of six-minute walk test
|
Week 0
|
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Six-minute walk distance
Time Frame: Week 4
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The distance of six-minute walk test
|
Week 4
|
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Six-minute walk distance
Time Frame: Week 8
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The distance of six-minute walk test
|
Week 8
|
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Six-minute walk distance
Time Frame: Week 12
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The distance of six-minute walk test
|
Week 12
|
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Six-minute walk distance
Time Frame: Week 24
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The distance of six-minute walk test
|
Week 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximal upper limb strength
Time Frame: Week 0
|
Hand grip strength
|
Week 0
|
|
Maximal upper limb strength
Time Frame: Week 4
|
Hand grip strength
|
Week 4
|
|
Maximal upper limb strength
Time Frame: Week 8
|
Hand grip strength
|
Week 8
|
|
Maximal upper limb strength
Time Frame: Week 12
|
Hand grip strength
|
Week 12
|
|
Maximal upper limb strength
Time Frame: Week 24
|
Hand grip strength
|
Week 24
|
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Maximal lower limb strength
Time Frame: Week 0
|
Leg press strength
|
Week 0
|
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Maximal lower limb strength
Time Frame: Week 4
|
Leg press strength
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Week 4
|
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Maximal lower limb strength
Time Frame: Week 8
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Leg press strength
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Week 8
|
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Maximal lower limb strength
Time Frame: Week 12
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Leg press strength
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Week 12
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Maximal lower limb strength
Time Frame: Week 24
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Leg press strength
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Week 24
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Maximal respiratory muscle strength
Time Frame: Week 0
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Inspiratory and expiratory pressure of respiratory muscle
|
Week 0
|
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Maximal respiratory muscle strength
Time Frame: Week 4
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Inspiratory and expiratory pressure of respiratory muscle
|
Week 4
|
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Maximal respiratory muscle strength
Time Frame: Week 8
|
Inspiratory and expiratory pressure of respiratory muscle
|
Week 8
|
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Maximal respiratory muscle strength
Time Frame: Week 12
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Inspiratory and expiratory pressure of respiratory muscle
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Week 12
|
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Maximal respiratory muscle strength
Time Frame: Week 24
|
Inspiratory and expiratory pressure of respiratory muscle
|
Week 24
|
|
Quality of life score
Time Frame: Week 0
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Quality of life assessed by Short-form 12 questionnaire
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Week 0
|
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Quality of life score
Time Frame: Week 4
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Quality of life assessed by Short-form 12 questionnaire
|
Week 4
|
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Quality of life score
Time Frame: Week 8
|
Quality of life assessed by Short-form 12 questionnaire
|
Week 8
|
|
Quality of life score
Time Frame: Week 12
|
Quality of life assessed by Short-form 12 questionnaire
|
Week 12
|
|
Quality of life score
Time Frame: Week 24
|
Quality of life assessed by Short-form 12 questionnaire
|
Week 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ping-Lun Hsieh, National Taiwan University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Felten-Barentsz KM, van Oorsouw R, Klooster E, Koenders N, Driehuis F, Hulzebos EHJ, van der Schaaf M, Hoogeboom TJ, van der Wees PJ. Recommendations for Hospital-Based Physical Therapists Managing Patients With COVID-19. Phys Ther. 2020 Aug 31;100(9):1444-1457. doi: 10.1093/ptj/pzaa114.
- Gloeckl R, Leitl D, Jarosch I, Schneeberger T, Nell C, Stenzel N, Vogelmeier CF, Kenn K, Koczulla AR. Benefits of pulmonary rehabilitation in COVID-19: a prospective observational cohort study. ERJ Open Res. 2021 May 31;7(2):00108-2021. doi: 10.1183/23120541.00108-2021. eCollection 2021 Apr.
- Betschart M, Rezek S, Unger I, Beyer S, Gisi D, Shannon H, Sieber C. Feasibility of an Outpatient Training Program after COVID-19. Int J Environ Res Public Health. 2021 Apr 9;18(8):3978. doi: 10.3390/ijerph18083978.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 12, 2023
Primary Completion (Actual)
May 24, 2024
Study Completion (Actual)
May 24, 2024
Study Registration Dates
First Submitted
March 13, 2023
First Submitted That Met QC Criteria
March 20, 2023
First Posted (Actual)
March 21, 2023
Study Record Updates
Last Update Posted (Estimated)
September 11, 2025
Last Update Submitted That Met QC Criteria
September 4, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202106133RIND
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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