Back to resultsTeletechnology-assisted Home-based Exercise Program for Severe COVID-19
Primary Purpose
COVID-19, Telerehabilitation
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Teletechnology-assisted home-based pulmonary rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Pulmonary Rehabilitation
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.
Sites / Locations
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Home-based pulmonary rehabilitation group
Usual care group
Arm Description
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).
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.
Outcomes
Primary Outcome Measures
Six-minute walk distance
The distance of six-minute walk test
Six-minute walk distance
The distance of six-minute walk test
Six-minute walk distance
The distance of six-minute walk test
Six-minute walk distance
The distance of six-minute walk test
Six-minute walk distance
The distance of six-minute walk test
Secondary Outcome Measures
Maximal upper limb strength
Hand grip strength
Maximal upper limb strength
Hand grip strength
Maximal upper limb strength
Hand grip strength
Maximal upper limb strength
Hand grip strength
Maximal upper limb strength
Hand grip strength
Maximal lower limb strength
Leg press strength
Maximal lower limb strength
Leg press strength
Maximal lower limb strength
Leg press strength
Maximal lower limb strength
Leg press strength
Maximal lower limb strength
Leg press strength
Maximal respiratory muscle strength
Inspiratory and expiratory pressure of respiratory muscle
Maximal respiratory muscle strength
Inspiratory and expiratory pressure of respiratory muscle
Maximal respiratory muscle strength
Inspiratory and expiratory pressure of respiratory muscle
Maximal respiratory muscle strength
Inspiratory and expiratory pressure of respiratory muscle
Maximal respiratory muscle strength
Inspiratory and expiratory pressure of respiratory muscle
Quality of life score
Quality of life assessed by Short-form 12 questionnaire
Quality of life score
Quality of life assessed by Short-form 12 questionnaire
Quality of life score
Quality of life assessed by Short-form 12 questionnaire
Quality of life score
Quality of life assessed by Short-form 12 questionnaire
Quality of life score
Quality of life assessed by Short-form 12 questionnaire
Full Information
NCT ID
NCT05778344
First Posted
March 13, 2023
Last Updated
April 17, 2023
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05778344
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Telerehabilitation
Keywords
Pulmonary Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Home-based pulmonary rehabilitation group
Arm Type
Experimental
Arm Description
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).
Arm Title
Usual care group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Teletechnology-assisted home-based pulmonary rehabilitation
Intervention Description
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).
Primary Outcome Measure Information:
Title
Six-minute walk distance
Description
The distance of six-minute walk test
Time Frame
Week 0
Title
Six-minute walk distance
Description
The distance of six-minute walk test
Time Frame
Week 4
Title
Six-minute walk distance
Description
The distance of six-minute walk test
Time Frame
Week 8
Title
Six-minute walk distance
Description
The distance of six-minute walk test
Time Frame
Week 12
Title
Six-minute walk distance
Description
The distance of six-minute walk test
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Maximal upper limb strength
Description
Hand grip strength
Time Frame
Week 0
Title
Maximal upper limb strength
Description
Hand grip strength
Time Frame
Week 4
Title
Maximal upper limb strength
Description
Hand grip strength
Time Frame
Week 8
Title
Maximal upper limb strength
Description
Hand grip strength
Time Frame
Week 12
Title
Maximal upper limb strength
Description
Hand grip strength
Time Frame
Week 24
Title
Maximal lower limb strength
Description
Leg press strength
Time Frame
Week 0
Title
Maximal lower limb strength
Description
Leg press strength
Time Frame
Week 4
Title
Maximal lower limb strength
Description
Leg press strength
Time Frame
Week 8
Title
Maximal lower limb strength
Description
Leg press strength
Time Frame
Week 12
Title
Maximal lower limb strength
Description
Leg press strength
Time Frame
Week 24
Title
Maximal respiratory muscle strength
Description
Inspiratory and expiratory pressure of respiratory muscle
Time Frame
Week 0
Title
Maximal respiratory muscle strength
Description
Inspiratory and expiratory pressure of respiratory muscle
Time Frame
Week 4
Title
Maximal respiratory muscle strength
Description
Inspiratory and expiratory pressure of respiratory muscle
Time Frame
Week 8
Title
Maximal respiratory muscle strength
Description
Inspiratory and expiratory pressure of respiratory muscle
Time Frame
Week 12
Title
Maximal respiratory muscle strength
Description
Inspiratory and expiratory pressure of respiratory muscle
Time Frame
Week 24
Title
Quality of life score
Description
Quality of life assessed by Short-form 12 questionnaire
Time Frame
Week 0
Title
Quality of life score
Description
Quality of life assessed by Short-form 12 questionnaire
Time Frame
Week 4
Title
Quality of life score
Description
Quality of life assessed by Short-form 12 questionnaire
Time Frame
Week 8
Title
Quality of life score
Description
Quality of life assessed by Short-form 12 questionnaire
Time Frame
Week 12
Title
Quality of life score
Description
Quality of life assessed by Short-form 12 questionnaire
Time Frame
Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ping-Lun Hsieh, MSc
Phone
+886-905925933
Email
107673@ntuh.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ping-Lun Hsieh
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping-Lun Hsieh, MSc
Phone
886-905925933
Email
107673@ntuh.gov.tw
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32556323
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.
Results Reference
background
PubMed Identifier
34095290
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.
Results Reference
background
PubMed Identifier
33918887
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.
Results Reference
result
Learn more about this trial
Teletechnology-assisted Home-based Exercise Program for Severe COVID-19
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