COVID-19 trials registries data warehouse

http://www.ensaiosclinicos.gov.br/rg/RBR-6m69fc

Carlos Utrera

cbernal495@gmail.com

2020-04-02

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)

3

Universidad de Sevilla

18

75

Spain

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

0

Multidimensional Dysphnoea-12 (MD12) Spanish version. The MD12 questionnaire will be self-administered and will be performed at the end of the 6MWT. Patients will send the results of MD12 screenshot daily to the evaluator; via WhatsApp or email. ;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 daily to the evaluator; via WhatsApp or email. ;hirty Seconds Sit-To-Stand Test (30STST). Evaluators will ask patients to place a straight-backed armless chair; with a hard seat ; which will be stabilized by placing it against a wall; considering floor to seat height will be between 45 - 50 cm. Seated participants will asked to come forward on the seat until their feet will be flat on the floor; and to fold their upper limbs across the chest; without moving it during all test. Patients will be then instructed to stand up all the way and sit down once without using the upper limbs. Patients will start in the seated position on the chair and; upon command telematically; they will stand up; and then they will return to sitting as many times as they could; in a 30-second time period. The evaluators will control this test telematically by videoconference.

Not reported

[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 1108, "treatment_name": "Respiratory exercise program (rep)", "treatment_type": "Rehabilitation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 907, "treatment_name": "Non-specific toning exercise program (ntep)", "treatment_type": "Rehabilitation", "pharmacological_treatment": "Non pharmacological treatment"}]