COVID-19 trials registries data warehouse

https://anzctr.org.au/ACTRN12622000742774.aspx

Raden Argarini

raden-a@fk.unair.ac.id

2022-05-24

Not recruiting

RCT

Randomized

Parallel

Blind label

unclear

Long covid

Participants with long COVID-19 criteria (3-12 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)

Patients post-acute COVID-19 without symptoms Have a musculoskeletal condition that impairs their ability to undertake exercise training.

2

Universitas Airlangga

18

70

Indonesia

Patients recovered from covid

N/A

100

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.[Vascular endothelial function will be assessed at baseline and 3 days after the last exercise session (to prevent the influence of the last exercise)];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 inhalationAll the tests will be performed 3x by following the instructor's guidance and will be encouraged verbally to achieve optimal results.[Respiratory function will be assessed at baseline and 3 days after the last exercise session (to prevent the influence of the last exercise).];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. [Cardiorespiratory fitness will be assessed at baseline and 3 days after exercise training (to prevent the influence of the last exercise).]

Not reported

[{"arm_notes": "", "treatment_id": 41, "treatment_name": "Aerobic exercise", "treatment_type": "Rehabilitation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]