Clinical trial NCT05778344: Teletechnology-assisted Home-based Exercise Program for Severe COVID-19
Official title: Efficacy of Teletechnology-assisted Home-based Exercise Program for Severe COVID-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Telerehabilitation
Keywords: Pulmonary Rehabilitation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Six-minute walk distance
timeFrame: Week 0
measure: Six-minute walk distance
timeFrame: Week 4
measure: Six-minute walk distance
timeFrame: Week 8
measure: Six-minute walk distance
timeFrame: Week 12
measure: Six-minute walk distance
timeFrame: Week 24
Secondary outcomes:
measure: Maximal upper limb strength
timeFrame: Week 0
measure: Maximal upper limb strength
timeFrame: Week 4
measure: Maximal upper limb strength
timeFrame: Week 8
measure: Maximal upper limb strength
timeFrame: Week 12
measure: Maximal upper limb strength
timeFrame: Week 24
measure: Maximal lower limb strength
timeFrame: Week 0
measure: Maximal lower limb strength
timeFrame: Week 4
measure: Maximal lower limb strength
timeFrame: Week 8
measure: Maximal lower limb strength
timeFrame: Week 12
measure: Maximal lower limb strength
timeFrame: Week 24
measure: Maximal respiratory muscle strength
timeFrame: Week 0
measure: Maximal respiratory muscle strength
timeFrame: Week 4
measure: Maximal respiratory muscle strength
timeFrame: Week 8
measure: Maximal respiratory muscle strength
timeFrame: Week 12
measure: Maximal respiratory muscle strength
timeFrame: Week 24
measure: Quality of life score
timeFrame: Week 0
measure: Quality of life score
timeFrame: Week 4
measure: Quality of life score
timeFrame: Week 8
measure: Quality of life score
timeFrame: Week 12
measure: Quality of life score
timeFrame: Week 24
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Ping-Lun Hsieh
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.