COVID-19 trials registries data warehouse

http://ensaiosclinicos.gov.br/rg/RBR-4j9wkbz

Carlos Utrera

cbernal495@gmail.com

2021-04-05

Not recruiting

RCT

Randomized

Parallel

Blind label

unclear

Treatment

Patients between 18-75 years who are affected by coronavirus (COVID-19), and are in home confinement.

Patients with chronic lung conditions, Patients with chronic kidney disease, Patients affected with chronic neurological disorders, Patients suffering from hypertension and cardiovascular conditions without medical treatment, Patients affected with grade III osteoporosis, Patients affected with acute outbreaks of rheumatologic disorders, Patients affected with acute outbreaks disc abnormalities, Patients who have had respiratory conditions in the last 12 months, Patients who have recent musculoskeletal disorders, and who are not fully recovered from their injuries, Patients who have received physical therapy treatment in the last 3 months, Patients affected with chronic mental and / or psychological disturbances, Red Flags (Night pain, severe muscle spasm, loss of involuntary weight, symptom mismatch)

2

Universidad de Sevilla

18

75

Spain

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

0

Outcome expected 1. Six Minute Walk Test (6MWT). The 6MWT will be performed by all patients in their home; under the telematically supervision of a physiotherapist. All patients will receive the same instructions before the walk; and will be encouraged by the physiotherapist who repeated set phrases every minute during the walk. The distance covered during the test will be recorded in meters telematically by patient smartphone. Patients will be allowed to stop and rest during the test but they will be instructed to resume walking as soon as they felt able to do so. Patients will send the results of 6MWT screenshot to the evaluator; via WhatsApp or email. from the observation of a variation of at least 10% in the pre and post-intervention measurements;Outcome expected 2. Borg Scale (BS). The Borg scale; of perceived effort; measures the entire range of effort that the individual perceives when exercising. This scale gives criteria to make adjustments to the intensity of exercise; that is; to the workload; and thus forecast and dictate the different intensities of exercise in sports and medical rehabilitation. from the observation of a variation of at least 10% in the pre and post-intervention measurements;Outcome expected 3. Visual Analog Scale Fatigue (VASF); for fatigue measurement. Patients participating in the study will indicate the intensity of their fatigue by means of the VAS through the Smartphone application called “Visual Scale” (Apple Store and Google Play). They will have to signal in a horizontal line where they would place their fatigue; being 0 no fatigue and the 10 would be the worst imaginable fatigue”. VASF will be controlled telematically by the evaluators through the Smartphone application. The evaluator will ask the patient to indicate their level of VASF in the Visual Scale application; and to take a screenshot of the smartphone to obtain the established value for VASF; which is calculated as the average value of two attempts. The patient must send the VASF screenshot to the evaluator; via WhatsApp or email. from the observation of a variation of at least 10% in the pre and post-intervention measurements

Not reported

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