- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06251011
Effects of Physiotherapy Via Telerehabilitation in Patients With COVID-19
February 27, 2024 updated by: Pooriput Waongenngarm, PT, PhD, Chulabhorn Hospital
Effects of Physiotherapy Via Telerehabilitation on Cardiopulmonary, Physical, and Psychological Functions in Patients With COVID-19: A Randomized Controlled Trial
This study aims to evaluate the effects of Physiotherapy Via Video Calls on Cardiopulmonary Functions, Physical Function, Cognitive Function, Activity Daily Livings, and Quality of Life in Patients With COVID-19.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Detailed Description
A 2-armed, parallel-group, randomized controlled trial was conducted at Chulabhorn Hospital, Thailand on a convenience sample of patients who tested positive for COVID-19 using RT-PCR.
Study Type
Interventional
Enrollment (Estimated)
30
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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Bangkok
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Lak Si, Bangkok, Thailand, 10210
- Chulabhorn 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
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age between 20-60 years old
- Positive in COVID-19 testing
- Good communication and understanding
- Independent mobility
Exclusion Criteria:
- Cannot complete the study protocol
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 |
---|---|
No Intervention: Control group
Receive an advice and a leaflet for cardiopulmonary rehabilitation.
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|
Experimental: Physiotherapy group
Receive the physical therapy training via video call (Pulmonary training, Calisthenic exercise, Upper and lower limbs strengthening exercise, Core stabilizer exercise, Aerobic exercise) at day 3, 6, 9, 12, 16, and 21 after positive in COVID-19 testing and also receive advise and a leaflet for cardiopulmonary rehabilitation.
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiopulmonary function
Time Frame: at day 28 and 90 after positive in COVID-19 testing
|
using Cardiopulmonary exercise testing (CPET)
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at day 28 and 90 after positive in COVID-19 testing
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Patient's quality of life
Time Frame: at day 3 and 21 after positive in COVID-19 testing
|
using the The World Health Organization Quality of Life (WHOQOL-BREF-THAI) 26 items; the final score ranges from 24-120; higher score means participants satisfied with the quality of life.
|
at day 3 and 21 after positive in COVID-19 testing
|
Functional capacity
Time Frame: at day 3 and 21 after positive in COVID-19 testing
|
using Duke Activity status index The final score ranges between zero and 58.2 points; The higher the score, the better the functional capacity.
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at day 3 and 21 after positive in COVID-19 testing
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Anxiety and depression
Time Frame: at day 3 and 21 after positive in COVID-19 testing
|
using Hospital Anxiety and Depression Scale (HADS) The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21).
A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety or depression.
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at day 3 and 21 after positive in COVID-19 testing
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Insomnia
Time Frame: at day 3 and 21 after positive in COVID-19 testing
|
using Insomnia Severity Index (ISI) The final score ranges between zero and 28 points.
The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
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at day 3 and 21 after positive in COVID-19 testing
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Cognitive function
Time Frame: at day 3 and 21 after positive in COVID-19 testing
|
using Thai Mental State Examination The final score ranges between zero and 30 points.
A score of 25 or higher is classed as normal.
If the score is below 24, the result is usually considered to be abnormal, indicating possible cognitive impairment.
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at day 3 and 21 after positive in COVID-19 testing
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Muscle strength
Time Frame: at day 3 and 21 after positive in COVID-19 testing
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using 1-minute sit to stand
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at day 3 and 21 after positive in COVID-19 testing
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Pooriput Waongenngarm, PhD, Chulabhorn Royal Academy
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)
February 9, 2024
Primary Completion (Estimated)
June 1, 2024
Study Completion (Estimated)
June 15, 2024
Study Registration Dates
First Submitted
February 7, 2024
First Submitted That Met QC Criteria
February 7, 2024
First Posted (Actual)
February 9, 2024
Study Record Updates
Last Update Posted (Actual)
February 28, 2024
Last Update Submitted That Met QC Criteria
February 27, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Disease Attributes
- Chronic Disease
- Post-Infectious Disorders
- COVID-19
- Post-Acute COVID-19 Syndrome
Other Study ID Numbers
- EC014/2565
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Due to the ethical restriction, investigators cannot share any individual participant data.
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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