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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
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.
Secondary ID [1] 307147 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Long COVID-19 326339 0
Condition category
Condition code
Respiratory 323648 323648 0 0
Other respiratory disorders / diseases
Infection 323707 323707 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 323600 0
Lifestyle
Intervention code [2] 323646 0
Treatment: Other
Intervention code [3] 323647 0
Rehabilitation
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),
Control group
Active

Outcomes
Primary outcome [1] 331397 0
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.
Timepoint [1] 331397 0
Vascular endothelial function will be assessed at baseline and 3 days after the last exercise session (to prevent the influence of the last exercise)
Primary outcome [2] 331398 0
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.
Timepoint [2] 331398 0
Respiratory function will be assessed at baseline and 3 days after the last exercise session (to prevent the influence of the last exercise).
Primary outcome [3] 331404 0
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.
Timepoint [3] 331404 0
Cardiorespiratory fitness will be assessed at baseline and 3 days after exercise training (to prevent the influence of the last exercise).
Secondary outcome [1] 409732 0
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.
Timepoint [1] 409732 0
Symptoms of participants will be assessed at baseline and 3 days after exercise training (to prevent the influence of the last exercise).
Secondary outcome [2] 409733 0
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).
Timepoint [2] 409733 0
Mental health of participants will be assessed at baseline and 3 days after exercise training (to prevent the influence of the last exercise).
Secondary outcome [3] 409736 0
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.
Timepoint [3] 409736 0
Handgrip strength will be assessed at baseline and 3 days after exercise training (to prevent the influence of the last exercise).
Secondary outcome [4] 409738 0
Inflammatory marker (Interleukin-6) will be assessed from venous blood sample (serum) using ELISA technique.
Timepoint [4] 409738 0
Inflammatory marker (Interleukin-6) will be assessed at baseline and 3 days after exercise training (to prevent the influence of the last exercise).
Secondary outcome [5] 409961 0
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.
Timepoint [5] 409961 0
Upper body strength will be assessed at baseline and 3 days after exercise training (to prevent the influence of the last exercise).

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)
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients post-acute COVID-19 without symptoms
Have a musculoskeletal condition that impairs their ability to undertake exercise training.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/05/2022
Actual
28/05/2022
Date of last participant enrolment
Anticipated
31/10/2022
Actual
Date of last data collection
Anticipated
5/12/2022
Actual
Sample size
Target
100
Accrual to date
18
Final
Recruitment outside Australia
Country [1] 24780 0
Indonesia
State/province [1] 24780 0
East Java

Funding & Sponsors
Funding source category [1] 311451 0
University
Name [1] 311451 0
Universitas Airlangga
Country [1] 311451 0
Indonesia
Primary sponsor type
University
Name
Universitas Airlangga
Address
Jl. Dr. Ir. H. Soekarno, Mulyorejo, Kec. Mulyorejo, Kota SBY, Jawa Timur 60115 (Campus C)
Country
Indonesia
Secondary sponsor category [1] 312846 0
None
Name [1] 312846 0
Address [1] 312846 0
Country [1] 312846 0
Other collaborator category [1] 282314 0
Other Collaborative groups
Name [1] 282314 0
Cardiovascular Research Group, School of Human Sciences – Sport Science, Exercise and Health, The University of Western Australia
Address [1] 282314 0
35 Stirling Highway
Crawley, 6009
Western Australia
Country [1] 282314 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310923 0
Ethics Committee of Rumah Sakit Universitas Airlangga (Airlangga University Educational Hospital)
Ethics committee address [1] 310923 0
Ethics committee country [1] 310923 0
Indonesia
Date submitted for ethics approval [1] 310923 0
Approval date [1] 310923 0
26/11/2021
Ethics approval number [1] 310923 0
201/KEP/2021

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119362 0
Dr Raden Argarini
Address 119362 0
Faculty of Medicine, Airlangga University.
Campus A - Jln. Prof. Dr. Moestopo No. 47, Surabaya, East Java
Postal code: 60131
Country 119362 0
Indonesia
Phone 119362 0
+62315023621
Fax 119362 0
+62315022472
Email 119362 0
raden-a@fk.unair.ac.id
Contact person for public queries
Name 119363 0
Raden Argarini
Address 119363 0
Faculty of Medicine, Airlangga University.
Campus A - Jln. Prof. Dr. Moestopo No. 47, Surabaya, East Java
Postal code: 60131
Country 119363 0
Indonesia
Phone 119363 0
+62315023621
Fax 119363 0
+62315022472
Email 119363 0
raden-a@fk.unair.ac.id
Contact person for scientific queries
Name 119364 0
Raden Argarini
Address 119364 0
Faculty of Medicine, Airlangga University.
Campus A - Jln. Prof. Dr. Moestopo No. 47, Surabaya, East Java
Postal code: 60131
Country 119364 0
Indonesia
Phone 119364 0
+62315023621
Fax 119364 0
+62315022472
Email 119364 0
raden-a@fk.unair.ac.id

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
According to the regulation of the ethical committee, we are not allowed to share any individual participant data


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.