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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05778344
• Other study ID #: 202106133RIND
• Status: Recruiting
• Phase: N/A
• Start date: April 12, 2023
• Est. completion date: December 2023

Study information

• Verified date: April 2023
• Source: National Taiwan University Hospital
• Contact: Ping-Lun Hsieh, MSc
• Phone: +886-905925933
• Email: 107673[@]ntuh.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Telerehabilitation

Intervention

Behavioral:
• Teletechnology-assisted home-based pulmonary rehabilitation
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).

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six-minute walk distance	The distance of six-minute walk test	Week 0
Primary	Six-minute walk distance	The distance of six-minute walk test	Week 4
Primary	Six-minute walk distance	The distance of six-minute walk test	Week 8
Primary	Six-minute walk distance	The distance of six-minute walk test	Week 12
Primary	Six-minute walk distance	The distance of six-minute walk test	Week 24
Secondary	Maximal upper limb strength	Hand grip strength	Week 0
Secondary	Maximal upper limb strength	Hand grip strength	Week 4
Secondary	Maximal upper limb strength	Hand grip strength	Week 8
Secondary	Maximal upper limb strength	Hand grip strength	Week 12
Secondary	Maximal upper limb strength	Hand grip strength	Week 24
Secondary	Maximal lower limb strength	Leg press strength	Week 0
Secondary	Maximal lower limb strength	Leg press strength	Week 4
Secondary	Maximal lower limb strength	Leg press strength	Week 8
Secondary	Maximal lower limb strength	Leg press strength	Week 12
Secondary	Maximal lower limb strength	Leg press strength	Week 24
Secondary	Maximal respiratory muscle strength	Inspiratory and expiratory pressure of respiratory muscle	Week 0
Secondary	Maximal respiratory muscle strength	Inspiratory and expiratory pressure of respiratory muscle	Week 4
Secondary	Maximal respiratory muscle strength	Inspiratory and expiratory pressure of respiratory muscle	Week 8
Secondary	Maximal respiratory muscle strength	Inspiratory and expiratory pressure of respiratory muscle	Week 12
Secondary	Maximal respiratory muscle strength	Inspiratory and expiratory pressure of respiratory muscle	Week 24
Secondary	Quality of life score	Quality of life assessed by Short-form 12 questionnaire	Week 0
Secondary	Quality of life score	Quality of life assessed by Short-form 12 questionnaire	Week 4
Secondary	Quality of life score	Quality of life assessed by Short-form 12 questionnaire	Week 8
Secondary	Quality of life score	Quality of life assessed by Short-form 12 questionnaire	Week 12
Secondary	Quality of life score	Quality of life assessed by Short-form 12 questionnaire	Week 24