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Trial registered on ANZCTR
Registration number
ACTRN12622000742774
Ethics application status
Approved
Date submitted
18/05/2022
Date registered
24/05/2022
Date last updated
26/08/2022
Date data sharing statement initially provided
24/05/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
The effect of a rehabilitation and exercise program on physical function in patients with long COVID-19 using a mobile interactive application
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Scientific title
The effect of a rehabilitation and exercise program delivered via a mobile interactive application on vascular endothelial and cardiorespiratory function in patients with long COVID-19.
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Secondary ID [1]
307147
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Long COVID-19
326339
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Condition category
Condition code
Respiratory
323648
323648
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0
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Other respiratory disorders / diseases
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Infection
323707
323707
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0
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The participants will be randomly allocated into the control and intervention groups. The participants in the intervention group should maintain their level of physical activity and standard care (medicine and/or physical rehabilitation program) and they will receive additional exercise programs and supervision delivered via mobile interactive platforms.
Exercise intervention:
Each exercise session will include the aerobic and resistance training that will start at the mild intensity (RPE 6-8) and progressively increase by 2 RPE each week to moderate intensity (RPE 13-14). For aerobic exercise, the participants will follow the movements from video for example bicep steps back, soft clap jack, soft high knee, etc. For resistance exercise, they will need simple exercise equipment such as a chair and dumbbell (this will be provided by the research team). The example of resistance exercise movement is bottle biceps curl, calf raise, chair squat, wall push-up, etc. Exercise sessions will be performed 3x per week for a total of 4 weeks. Each exercise session will be approximately 20-40 minutes in duration. All participants will be assessed for their cardiorespiratory fitness and muscle strength prior to their allocation to the exercise program. The exercise session will be delivered by mobile interactive application that is specifically designed for this study with the basis one-on-one by following the video containing the exercise program embedded in the application. The exercise session will be supervised by exercise physiologist or physical-rehabilitation specialist (medical doctor). Each supervisor will responsible for up to 5 participants. At the end of the exercise, participants will be asked to fill the RPE and will be notified when is the next exercise session according to the participant’s preference of time. The application system will also record the participant’s attendance in the exercise session. The supervisor can also monitor the adherence and RPE of participants through their dashboard.
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Intervention code [1]
323600
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Lifestyle
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Intervention code [2]
323646
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Treatment: Other
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Intervention code [3]
323647
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Rehabilitation
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Comparator / control treatment
All participants in the control group should maintain their level of physical activity and standard care (medicine and/or physical rehabilitation program),
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Control group
Active
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Outcomes
Primary outcome [1]
331397
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Vascular endothelial function (composite primary outcome): Assessed via flow-mediated dilation which is a non-invasive high-resolution ultrasound (Terason, t3200, Burlington, MA 01803, USA) imaging technique of the brachial artery which will be performed on the arm. Images will be optimised and recordings taken during a 1 minute resting baseline which will be followed by the inflation of an occlussion cuff for 5 min to 220 mmHg around the forearm. Scanning will be continued following deflation of the cuff for 3 min. Continuous (30 Hz) brachial lumen cross-sectional area and Doppler velocity will be used to calculate brachial blood flow and shear stress, along with changes in arterial diameter. FMD will be calculated in absolute (mm) and relative (%) terms as the increase from the 1 min resting baseline diameter.
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Assessment method [1]
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Timepoint [1]
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Vascular endothelial function will be assessed at baseline and 3 days after the last exercise session (to prevent the influence of the last exercise)
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Primary outcome [2]
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Respiratory function will be assessed as a composite primary outcome. This outcome will be measured by spirometry (BTL 08 Spiro, United Kingdom). There are 3 measurements that will be assessed: relaxed, forced (with and without bronchodilator), and maximal voluntary volume (MVV). Prior to performing spirometry, the patient's identification is checked. The participants grip the pneumotachometer in sitting position and will perform the spirometer test in following sequence:
1. Relaxed spirometry: The participants enclose the mouthpiece of the spirometer in their lips and breathe calmly, and then they will be asked to perform a maximal deep expiration without major effort until all the air is emptied from the lungs, and then slowly breathe until the maximum aspiration (so-called expiratory vital capacity procedure) and ask them again to perform everything conversely (so-called inspiratory vital capacity procedure).
2. Forced Spirometry: the participants will be asked to take a deep breath in, as large as possible aside from the spirometric module. Immediately after that, enclose the mouthpiece of the spirometer in his lips and blows out as hard and as fast as possible and keep going until there is no air left, continue with a deep breath in.
3. MVV: The participants enclose the mouthpiece of the spirometer in their lips and breathe calmly and then continue with deep and fast breathing for 20 seconds.
4. Bronchodilator inhalation (400 µg of salbutamol)
5. Repeat forced spirometry test, 4-5 minutes after bronchodilator inhalation
All the tests will be performed 3x by following the instructor's guidance and will be encouraged verbally to achieve optimal results.
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Assessment method [2]
331398
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Timepoint [2]
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Respiratory function will be assessed at baseline and 3 days after the last exercise session (to prevent the influence of the last exercise).
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Primary outcome [3]
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Cardiorespiratory fitness will be measured by 5 meters walking test. The participants will be asked to walk at a comfortable pace for 5 feet before the start, and 5 feet after the middle 5-meter section. The participants will perform 3 repetitions and calculate the average time.
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Assessment method [3]
331404
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Timepoint [3]
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Cardiorespiratory fitness will be assessed at baseline and 3 days after exercise training (to prevent the influence of the last exercise).
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Secondary outcome [1]
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Symptoms of participants will be evaluated by Edmonton Symptom Assessment Scale (ESAS). This is a nine-item patient-rated symptom visual analogue scale developed for use in assessing the symptoms of patients receiving palliative care.
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Assessment method [1]
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Timepoint [1]
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Symptoms of participants will be assessed at baseline and 3 days after exercise training (to prevent the influence of the last exercise).
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Secondary outcome [2]
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Mental health will be evaluated by Depression, Anxiety and Stress Scale - 21 Items (DASS-21). DASS-21 is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. The results will be expressed in scores and compared to cut-off scores for conventional severity labels (normal, moderate, severe).
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Assessment method [2]
409733
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Timepoint [2]
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Mental health of participants will be assessed at baseline and 3 days after exercise training (to prevent the influence of the last exercise).
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Secondary outcome [3]
409736
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Handgrip strength will be measured by handgrip dynamometer (Takei, Japan). The participants will be asked to hold the dynamometer in their hand to be tested, with the arm at right angles and the elbow by the side of the body. The handle of the dynamometer is adjusted if required - the base should rest on the first metacarpal (heel of palm), while the handle should rest on the middle of the four fingers. When ready the participants squeeze the dynamometer with maximum isometric effort, which is maintained for about 5 seconds. The participants will do this test for both hands with 2x repetition. The best value will be taken. The results of the Handgrip strength test will be expressed as units of weight in kilograms.
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Assessment method [3]
409736
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Timepoint [3]
409736
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Handgrip strength will be assessed at baseline and 3 days after exercise training (to prevent the influence of the last exercise).
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Secondary outcome [4]
409738
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Inflammatory marker (Interleukin-6) will be assessed from venous blood sample (serum) using ELISA technique.
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Assessment method [4]
409738
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Timepoint [4]
409738
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Inflammatory marker (Interleukin-6) will be assessed at baseline and 3 days after exercise training (to prevent the influence of the last exercise).
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Secondary outcome [5]
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Upper body strength will be measured by push and pull dynamometry (TTM, China) The participants will be asked to hold the dynamometer in front of the chest. When ready the participants pull the dynamometer with maximum isometric effort, which is maintained for about 5 seconds. The participants will do this test for 2x and the best value will be taken and continue with the push test. The results of the upper body strength test will be expressed as units of weight in kilograms.
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Assessment method [5]
409961
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Timepoint [5]
409961
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Upper body strength will be assessed at baseline and 3 days after exercise training (to prevent the influence of the last exercise).
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Eligibility
Key inclusion criteria
Participants with long COVID-19 criteria (3 months after the diagnosis of SARS-Cov-2 infection, continue to have signs and symptoms not explainable by other causes) in accordance with the guideline of the National Institute for Health and Care Excellence (NICE), Scottish Intercollegiate Guidelines Network (SIGN) and Royal College of General Practitioners (RCGP)
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients post-acute COVID-19 without symptoms
Have a musculoskeletal condition that impairs their ability to undertake exercise training.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
permuted block randomization thus each group will have same number of participants.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
30/05/2022
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Actual
28/05/2022
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Date of last participant enrolment
Anticipated
31/10/2022
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Actual
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Date of last data collection
Anticipated
5/12/2022
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Actual
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Sample size
Target
100
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Accrual to date
18
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Final
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Recruitment outside Australia
Country [1]
24780
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Indonesia
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State/province [1]
24780
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East Java
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Funding & Sponsors
Funding source category [1]
311451
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University
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Name [1]
311451
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Universitas Airlangga
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Address [1]
311451
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Jl. Dr. Ir. H. Soekarno, Mulyorejo, Kec. Mulyorejo, Kota SBY, Jawa Timur 60115 (Campus C)
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Country [1]
311451
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Indonesia
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Primary sponsor type
University
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Name
Universitas Airlangga
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Address
Jl. Dr. Ir. H. Soekarno, Mulyorejo, Kec. Mulyorejo, Kota SBY, Jawa Timur 60115 (Campus C)
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Country
Indonesia
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Secondary sponsor category [1]
312846
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None
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Name [1]
312846
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Address [1]
312846
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Country [1]
312846
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Other collaborator category [1]
282314
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Other Collaborative groups
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Name [1]
282314
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Cardiovascular Research Group, School of Human Sciences – Sport Science, Exercise and Health, The University of Western Australia
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Address [1]
282314
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35 Stirling Highway
Crawley, 6009
Western Australia
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Country [1]
282314
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
310923
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Ethics Committee of Rumah Sakit Universitas Airlangga (Airlangga University Educational Hospital)
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Ethics committee address [1]
310923
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Kampus C Mulyorejo, Jl. Dr. Ir. H. Soekarno, Mulyorejo, Kec. Mulyorejo, Kota SBY, Jawa Timur 60115
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Ethics committee country [1]
310923
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Indonesia
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Date submitted for ethics approval [1]
310923
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Approval date [1]
310923
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26/11/2021
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Ethics approval number [1]
310923
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201/KEP/2021
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Summary
Brief summary
COVID-19 is one of the greatest health crisis worldwide. Unfortunately, some COVID-19 survivors also experienced post-acute COVID-19 or long COVID, wherein the patients have persistent symptoms and illness that could last for several weeks to months or even longer, despite the clinical resolution. Long-COVID is a multisystem disease associated with a broad range of symptoms, including fever, fatigue, shortness of breath, chest pain, headaches, fatigue, neurocognitive difficulties, and mental health problems such as depression. Furthermore, increased lost fitness has also been reported in post-acute COVID-19 patients. As the number of patients recovering from COVID-19 grows, it is paramount to establish a comprehensive understanding of the healthcare issues post-acute COVID and subsequently, plan the rehabilitation program. Additionally, the guidance for clinicians for return to exercise in COVID-19 survivors is currently based on indirect evidence.
Considering the safety of health care providers, the rehabilitative or exercise program for post-acute COVID-19 is suggested to be held via telecommunication. This will limit contact between health care providers and patients and therefore reduce the risk of nosocomial spread while accelerating the recovery of patients with long COVID-19. However, one by one teleconsultation is not possible due to the high number of COVID cases and subsequently, COVID 19 survivors in Indonesia, therefore adopting digital technology to move the rehabilitation program into the online platform are easy to be employed. Despite the feasibility of this online platform to support the rehabilitative program, to date, the evidence of this technology specifically in patients with and after COVID in Indonesia is non-existent. Therefore, this study aims to implement exercise programs using mobile applications on the patients with long COVID-19. The results of this study have the potential to provide insight into the beneficial effect of exercise training using mobile application on vascular endothelial function, respiratory function, and cardiorespiratory fitness.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Raden Argarini
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Address
119362
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Faculty of Medicine, Airlangga University.
Campus A - Jln. Prof. Dr. Moestopo No. 47, Surabaya, East Java
Postal code: 60131
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Country
119362
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Indonesia
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Phone
119362
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+62315023621
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Fax
119362
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+62315022472
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Email
119362
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[email protected]
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Contact person for public queries
Name
119363
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Dr Raden Argarini
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Address
119363
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Faculty of Medicine, Airlangga University.
Campus A - Jln. Prof. Dr. Moestopo No. 47, Surabaya, East Java
Postal code: 60131
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Country
119363
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Indonesia
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Phone
119363
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+62315023621
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Fax
119363
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+62315022472
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Email
119363
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[email protected]
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Contact person for scientific queries
Name
119364
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Dr Raden Argarini
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Address
119364
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Faculty of Medicine, Airlangga University.
Campus A - Jln. Prof. Dr. Moestopo No. 47, Surabaya, East Java
Postal code: 60131
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Country
119364
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Indonesia
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Phone
119364
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+62315023621
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Fax
119364
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+62315022472
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Email
119364
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
According to the regulation of the ethical committee, we are not allowed to share any individual participant data
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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