Long COVID-19NCT05817032
Effect of Telerehabilitation Practice in Long COVID-19 Patients
A study testing Telerehabilitation and Standard rehabilitation care in people with Long COVID-19 and Long COVID, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
The goal of this clinical trial is to test the efficacy of telerehabilitation practice in Long COVID-19 patients. The main question[s] it aims to answer are whether telerehabilitation practice in Long COVID-19 patients help to reduce stress oxidative, reduce inflammation, improve functional capacity and improve… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Long COVID-19, Long COVID, Post COVID-19 Condition
- What is being tested?
- Telerehabilitation and Standard rehabilitation care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteIndonesia
- Study dates
- May 2023to Nov 2023
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- COVID-19 survivors
- Have at least one of the following sequelae:
- fatigue
- dyspnea and/or chronic cough
- joint and/or muscle pain
- headache
Show all 10Show fewer
- insomnia (difficulty sleeping)
- impaired concentration / memory
- Willing to take part in the telerehabilitation program regularly during the study
- Willing to participate in the research and sign the consent form
Who cannot join
- Unable to use the mobile phone application and zoom meet
- Unable to come to the hospital for examination or training (if needed)
- Cognitive impairment (MMSE <21)
- Neuromusculoskeletal disorder which will affect rehabilitation interventions
- Severe chronic lung disease
- Severe heart disease (Grade III-IV from the New York Heart Association)
Show all 9Show fewer
- Chronic kidney disorders
- Malignancy
- Severe autoimmune disease
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Fakultas Kedokteran Universitas Indonesia
Jakarta Pusat, DKI Jakarta, 10430
Nurul Paramita, MD, MBiomed, 6281281839593, nurul.paramita61@ui.ac.id
Nurul Paramita, MD, MBiomed
About this study
Official title: Effect of Telerehabilitation Practice in Long COVID-19 Patients: Impact on Stress Oxidative, Inflammation, Functional Capacity and Quality of Life
The goal of this clinical trial is to test the efficacy of telerehabilitation practice in Long COVID-19 patients. The main question[s] it aims to answer are whether telerehabilitation practice in Long COVID-19 patients help to reduce stress oxidative, reduce inflammation, improve functional capacity and improve quality of life.
Participants will receive 12 weeks of telerehabilitation practice Researchers will compare intervention group (that received telerehabilitation) and control group (that received standard treatment) to see if there is better outcome in intervention group.
Read the detailed description
Study background:
Several study show that some survivors of COVID-19 have post COVID-19 sequelae. Previous studies suggest that rehabilitation interventions with appropriate prescription of physical exercise can provide short, medium and long term health benefits. Telerehabilitation services are an innovative strategy to support rehabilitation intervention and hopefully able to increase compliance of patients to exercise program.
This study aims to prove the effectiveness of telerehabilitation in improving levels of inflammation, oxidative stress, functional capacity and quality of life in Long COVID-19 patients. Participants will be divided into intervention group and control group. Baseline measurement will be taken. Telerehabilitation will be given to the intervention group for 12 weeks. Control group will receive standard rehabilitation treatment. After 12 weeks post intervention measurement will be taken.
- Conditions
- Long COVID-19, Long COVID, Post COVID-19 Condition, Post-COVID-19 Syndrome, Post-COVID Syndrome
- Being tested
- Telerehabilitation, Standard rehabilitation care
- Keywords
- Long COVID-19, Telerehabilitation, rehabilitation, exercise
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationBehavioural
Exercise prescriptions will be given based on the result of baseline assessment. The intensity of the exercise prescription and level of monitoring will be tailored to each participant's ability and condition. Exercise will be prescribed by a Physical Medicine and Rehabilitation specialist in accordance with standard rehabilitation protocols. Exercise will consist of aerobic exercise, resistance exercise and breathing exercise. Participants are asked to commit to do at least 36 sessions of exercise. Participants will be allowed to have a hybrid approach (10-12 in person, 24-26 virtual) or fully virtual.
Standard rehabilitation careBehavioural
Exercise prescriptions will be given based on the result of baseline assessment. The intensity of the exercise prescription and level of monitoring will be tailored to each participant's ability and condition. Exercise will be prescribed by a Physical Medicine and Rehabilitation specialist in accordance with standard rehabilitation protocols. Exercise will consist of aerobic exercise, resistance exercise and breathing exercise. Participants are asked to commit to do at least 36 sessions of exercise. Participants will be allowed to have 10-12 in person exercise.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation group | Experimental | Baseline measurement will be done in the rehabilitation center. Prescription for rehabilitation will be determined based on the result of baseline measurement. Participants will receive rehabilitation intervention that include telerehabilitation (video conference regular meeting, text message reminder, and mobile app). Participants will attend a regular check up at the center once a month. After 12 weeks post intervention measurement will be taken. Receives: Behavioral: Telerehabilitation |
| Control group | Active comparator | Baseline measurement will be done in the rehabilitation center. Prescription for rehabilitation will be determined based on the result of baseline measurement. Participants will be given instruction how to do proper exercise training at home. Participants will attend a regular check up at the center once a month. After 12 weeks post intervention measurement will be taken. Receives: Behavioral: Standard rehabilitation care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in quality of life status measured using European Quality of Life 5 Dimension 5 Level (EQ 5D 5L) questionnaire at 12 weeks
European Quality of Life 5 Dimension 5 Level (EQ 5D 5L) questionnaire is a validated instrument to measure quality of life. It is a descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Measured: Baseline and week 12
Change from baseline the distance from Six Minute Walk Test at 12 weeks
Six minute walk test is a validated instrument developed by the American Thoracic Society and it was officially introduced in 2002, coming along with a comprehensive guideline. The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Measured: Baseline and week 12
Change from baseline the mean Glutathione (GSH)/ oxidized GSH (GSSG) ratio at 12 weeks
The ratio of reduced Glutathione (GSH) to oxidized GSH (GSSG) is an indicator of cellular health, with reduced GSH constituting up to 98% of cellular GSH under normal conditions. It will be measured using The Glutathione GSH/GSSG Assay Kit, which is designed to accurately measure total, reduced and oxidized glutathione in biological samples using an enzymatic method that utilizes Ellman's Reagent (DTNB) and glutathione reductase (GR).
Measured: Baseline and week 12
Change from baseline the mean endothelial microparticles at 12 weeks
Endothelial microparticles is an emerging marker of endothelial dysfunction and also considered to play a major biological role in inflammation, vascular injury, angiogenesis, and thrombosis. Techniques to measure circulating endothelial microparticles rely on differential centrifugation in platelet-free plasma and on the identification of cell-surface Cluster of Differentiations (CD) antigens.
Measured: Baseline and week 12
Secondary outcomes (2)
Change from baseline the score from Brief Fatigue Inventory (BFI) questionnaire at 12 weeks
Brief Fatigue Inventory (BFI) questionnaire is a valid instrument to assess the severity of fatigue and the impact of fatigue on daily functioning. A global fatigue score can be obtained by averaging all the items on the BFI.
Measured: Baseline and 12 weeks
Change from baseline the score from hand grip strength test using handgrip dynamometer at 12 weeks
The purpose of the handgrip strength test is to measure the maximum isometric strength of the hand and forearm muscles. Handgrip strength is important because people with strong hands tend to be strong elsewhere, so this test is often used as a general test of strength.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study startMay 2023 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVID-19Studies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurul Paramita, Universitas Indonesia
- Investigators
- Nurul Paramita, MD, MBiomed, Principal investigator, Fakultas Kedokteran Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817032
- Sponsor's protocol ID
- 21-07-0713
- Status last verified
- Apr 2023
- First submitted
- 16 Apr 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: individual participant data including study protocol and informed consent available upon personal request
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Telerehabilitation Practice in Long COVID-19 Patients: Impact on Stress Oxidative, Inflammation, Functional Capacity and Quality of Life
- ClinicalTrials.gov ID
- NCT05817032
- Acronym / sponsor ID
- 21-07-0713
- Conditions
- Long COVID-19, Long COVID, Post COVID-19 Condition, Post-COVID-19 Syndrome, Post-COVID Syndrome
- Keywords
- Long COVID-19, Telerehabilitation, rehabilitation, exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 18 Apr 2023 (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.
The goal of this clinical trial is to test the efficacy of telerehabilitation practice in Long COVID-19 patients. The main question[s] it aims to answer are whether telerehabilitation practice in Long COVID-19 patients help to reduce stress oxidative, reduce inflammation, improve functional capacity and improve quality of life.
Participants will receive 12 weeks of telerehabilitation practice Researchers will compare intervention group (that received telerehabilitation) and control group (that received standard treatment) to see if there is better outcome in intervention group.
Detailed description
Study background:
Several study show that some survivors of COVID-19 have post COVID-19 sequelae. Previous studies suggest that rehabilitation interventions with appropriate prescription of physical exercise can provide short, medium and long term health benefits. Telerehabilitation services are an innovative strategy to support rehabilitation intervention and hopefully able to increase compliance of patients to exercise program.
This study aims to prove the effectiveness of telerehabilitation in improving levels of inflammation, oxidative stress, functional capacity and quality of life in Long COVID-19 patients. Participants will be divided into intervention group and control group. Baseline measurement will be taken. Telerehabilitation will be given to the intervention group for 12 weeks. Control group will receive standard rehabilitation treatment. After 12 weeks post intervention measurement will be taken.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation group | Experimental | Behavioral: TelerehabilitationBaseline measurement will be done in the rehabilitation center. Prescription for rehabilitation will be determined based on the result of baseline measurement. Participants will receive rehabilitation intervention that include telerehabilitation (video conference regular meeting, text message reminder, and mobile app). Participants will attend a regular check up at the center once a month. After 12 weeks post intervention measurement will be taken. |
| Control group | Active comparator | Behavioral: Standard rehabilitation careBaseline measurement will be done in the rehabilitation center. Prescription for rehabilitation will be determined based on the result of baseline measurement. Participants will be given instruction how to do proper exercise training at home. Participants will attend a regular check up at the center once a month. After 12 weeks post intervention measurement will be taken. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- COVID-19 survivors
- Have at least one of the following sequelae:
- fatigue
- dyspnea and/or chronic cough
- joint and/or muscle pain
Key exclusion criteria (9 listed)
- Unable to use the mobile phone application and zoom meet
- Unable to come to the hospital for examination or training (if needed)
- Cognitive impairment (MMSE <21)
- Neuromusculoskeletal disorder which will affect rehabilitation interventions
- Severe chronic lung disease
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 |
|---|---|---|
| TelerehabilitationExercise prescriptions will be given based on the result of baseline assessment. The intensity of the exercise prescription and level of monitoring will be tailored to each participant's ability and condition. Exercise will be prescribed by a Physical Medicine and Rehabilitation specialist in accordance with standard rehabilitation protocols. Exercise will consist of aerobic exercise, resistance exercise and breathing exercise. Participants are asked to commit to do at least 36 sessions of exercise. Participants will be allowed to have a hybrid approach (10-12 in person, 24-26 virtual) or fully virtual. | Behavioural | Telerehabilitation group |
| Standard rehabilitation careExercise prescriptions will be given based on the result of baseline assessment. The intensity of the exercise prescription and level of monitoring will be tailored to each participant's ability and condition. Exercise will be prescribed by a Physical Medicine and Rehabilitation specialist in accordance with standard rehabilitation protocols. Exercise will consist of aerobic exercise, resistance exercise and breathing exercise. Participants are asked to commit to do at least 36 sessions of exercise. Participants will be allowed to have 10-12 in person exercise. | Behavioural | Control group |
Primary outcome
Change from baseline in quality of life status measured using European Quality of Life 5 Dimension 5 Level (EQ 5D 5L) questionnaire at 12 weeks
Time frame: Baseline and week 12
European Quality of Life 5 Dimension 5 Level (EQ 5D 5L) questionnaire is a validated instrument to measure quality of life. It is a descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Change from baseline the distance from Six Minute Walk Test at 12 weeks
Time frame: Baseline and week 12
Six minute walk test is a validated instrument developed by the American Thoracic Society and it was officially introduced in 2002, coming along with a comprehensive guideline. The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Change from baseline the mean Glutathione (GSH)/ oxidized GSH (GSSG) ratio at 12 weeks
Time frame: Baseline and week 12
The ratio of reduced Glutathione (GSH) to oxidized GSH (GSSG) is an indicator of cellular health, with reduced GSH constituting up to 98% of cellular GSH under normal conditions. It will be measured using The Glutathione GSH/GSSG Assay Kit, which is designed to accurately measure total, reduced and oxidized glutathione in biological samples using an enzymatic method that utilizes Ellman's Reagent (DTNB) and glutathione reductase (GR).
Change from baseline the mean endothelial microparticles at 12 weeks
Time frame: Baseline and week 12
Endothelial microparticles is an emerging marker of endothelial dysfunction and also considered to play a major biological role in inflammation, vascular injury, angiogenesis, and thrombosis. Techniques to measure circulating endothelial microparticles rely on differential centrifugation in platelet-free plasma and on the identification of cell-surface Cluster of Differentiations (CD) antigens.
2 secondary outcomes
Change from baseline the score from Brief Fatigue Inventory (BFI) questionnaire at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline the score from hand grip strength test using handgrip dynamometer at 12 weeks
Time frame: Baseline and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: Undecided. individual participant data including study protocol and informed consent available upon personal request
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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.
Nurul Paramita, MD, MBiomed principal investigator
Fakultas Kedokteran Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation and Standard rehabilitation care in people with Long COVID-19 and Long COVID, run by Universitas Indonesia at 1 site in Indonesia.
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 10 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 18 Apr 2023. 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 Indonesia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nurul Paramita, MD, MBiomed (6281281839593, nurul.paramita61@ui.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in quality of life status measured using European Quality of Life 5 Dimension 5 Level (EQ 5D 5L) questionnaire at 12 weeks (time frame: Baseline and week 12). The study lists 4 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 18 Apr 2023.