Teletechnology-assisted Home-based Exercise Program for Severe COVID-19

Study Overview
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Brief Summary
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The aim of this study is 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 are: 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 will receive 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 will not receive teletechnology-assisted consultations during the intervention period.

Official Title
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Efficacy of Teletechnology-assisted Home-based Exercise Program for Severe COVID-19

Conditions
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COVID-19, Telerehabilitation

Intervention / Treatment
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* Behavioral: Teletechnology-assisted home-based pulmonary rehabilitation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home-based pulmonary rehabilitation group<br>The home-based pulmonary rehabilitation group will receive breathing exercise instructions using online learning materials soon after randomization. The participants will receive a home-based exercise plan, which comprises aerobic exercise and resistance exercise with instruction sheets. The participants will also be given a smart watch (to record heart rate, step count and distance in daily life) and a portable pulse oximeter (to monitor heart pulse and oxygen saturation during exercise) for 12 weeks. Teletechnology will be incorporated into home-based pulmonary rehabilitation via videotelephony (or telephone calls if indicated). Time points for these teletechnology-assisted consultations will be at day 7, day 14 after randomization and every 2 weeks after that until the completion of the study (week 12). | Behavioral: Teletechnology-assisted home-based pulmonary rehabilitation<br>* 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).<br>|
| Active Comparator: Usual care group<br>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. | Behavioral: Teletechnology-assisted home-based pulmonary rehabilitation<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six-minute walk distance | The distance of six-minute walk test | Week 0 | 
| Six-minute walk distance | The distance of six-minute walk test | Week 4 | 
| Six-minute walk distance | The distance of six-minute walk test | Week 8 | 
| Six-minute walk distance | The distance of six-minute walk test | Week 12 | 
| Six-minute walk distance | The distance of six-minute walk test | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal upper limb strength | Hand grip strength | Week 0 | 
| Maximal upper limb strength | Hand grip strength | Week 4 | 
| Maximal upper limb strength | Hand grip strength | Week 8 | 
| Maximal upper limb strength | Hand grip strength | Week 12 | 
| Maximal upper limb strength | Hand grip strength | Week 24 | 
| Maximal lower limb strength | Leg press strength | Week 0 | 
| Maximal lower limb strength | Leg press strength | Week 4 | 
| Maximal lower limb strength | Leg press strength | Week 8 | 
| Maximal lower limb strength | Leg press strength | Week 12 | 
| Maximal lower limb strength | Leg press strength | Week 24 | 
| Maximal respiratory muscle strength | Inspiratory and expiratory pressure of respiratory muscle | Week 0 | 
| Maximal respiratory muscle strength | Inspiratory and expiratory pressure of respiratory muscle | Week 4 | 
| Maximal respiratory muscle strength | Inspiratory and expiratory pressure of respiratory muscle | Week 8 | 
| Maximal respiratory muscle strength | Inspiratory and expiratory pressure of respiratory muscle | Week 12 | 
| Maximal respiratory muscle strength | Inspiratory and expiratory pressure of respiratory muscle | Week 24 | 
| Quality of life score | Quality of life assessed by Short-form 12 questionnaire | Week 0 | 
| Quality of life score | Quality of life assessed by Short-form 12 questionnaire | Week 4 | 
| Quality of life score | Quality of life assessed by Short-form 12 questionnaire | Week 8 | 
| Quality of life score | Quality of life assessed by Short-form 12 questionnaire | Week 12 | 
| Quality of life score | Quality of life assessed by Short-form 12 questionnaire | Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary Rehabilitation