COVID-19NCT06251011
Effects of Physiotherapy Via Telerehabilitation in Patients With COVID-19
A study testing Exercise training in people with COVID-19 and Long COVID-19, run by Chulabhorn Hospital at 1 site in Thailand.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- COVID-19, Long COVID-19, Cardiopulmonary Function
- What is being tested?
- Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteThailand
- Study dates
- 9 Feb 2024to 4 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 20-60 years old
- Positive in COVID-19 testing
- Good communication and understanding
- Independent mobility
Who cannot join
- Cannot complete the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID-19, Long COVID-19, Cardiopulmonary Function, Physical Function
- Being tested
- Exercise training
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingBehavioural
- Physical therapy training via video call
- An advise and a leaflet for cardiopulmonary rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Receive an advice and a leaflet for cardiopulmonary rehabilitation. |
| Physiotherapy group | Experimental | 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. Receives: Behavioral: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiopulmonary function
using Cardiopulmonary exercise testing (CPET)
Measured: at day 28 and 90 after positive in COVID-19 testing
Patient's quality of life
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.
Measured: at day 3 and 21 after positive in COVID-19 testing
Functional capacity
using Duke Activity status index The final score ranges between zero and 58.2 points; The higher the score, the better the functional capacity.
Measured: at day 3 and 21 after positive in COVID-19 testing
Anxiety and depression
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.
Measured: at day 3 and 21 after positive in COVID-19 testing
Insomnia
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).
Measured: at day 3 and 21 after positive in COVID-19 testing
Cognitive function
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.
Measured: at day 3 and 21 after positive in COVID-19 testing
Muscle strength
using 1-minute sit to stand
Measured: at day 3 and 21 after positive in COVID-19 testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start9 Feb 2024
- Primary completion1 Jun 2024
- Study completion4 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulabhorn Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pooriput Waongenngarm, PT, PhD, Chulabhorn Hospital
- Investigators
- Pooriput Waongenngarm, PhD, Principal investigator, Chulabhorn Royal Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251011
- Sponsor's protocol ID
- EC014/2565
- Status last verified
- Jun 2024
- First submitted
- 7 Feb 2024
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the ethical restriction, investigators cannot share any individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physiotherapy Via Telerehabilitation on Cardiopulmonary, Physical, and Psychological Functions in Patients With COVID-19: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06251011
- Acronym / sponsor ID
- EC014/2565
- Conditions
- COVID-19, Long COVID-19, Cardiopulmonary Function, Physical Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Chulabhorn HospitalUniversity, hospital or other
- Study start
- 9 Feb 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 4 Jun 2024 (actual)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Receive an advice and a leaflet for cardiopulmonary rehabilitation. |
| Physiotherapy group | Experimental | Behavioral: Exercise trainingReceive 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 20-60 years old
- Positive in COVID-19 testing
- Good communication and understanding
- Independent mobility
Key exclusion criteria (1 listed)
- Cannot complete the study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise training1. Physical therapy training via video call 2. An advise and a leaflet for cardiopulmonary rehabilitation | Behavioural | Physiotherapy group |
Primary outcome
Cardiopulmonary function
Time frame: at day 28 and 90 after positive in COVID-19 testing
using Cardiopulmonary exercise testing (CPET)
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.
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.
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.
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).
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.
Muscle strength
Time frame: at day 3 and 21 after positive in COVID-19 testing
using 1-minute sit to stand
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Individual participant dataSharing planned: No. Due to the ethical restriction, investigators cannot share any individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pooriput Waongenngarm, PhD principal investigator
Chulabhorn Royal Academy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with COVID-19 and Long COVID-19, run by Chulabhorn Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiopulmonary function (time frame: at day 28 and 90 after positive in COVID-19 testing). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2024.