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Column | Value |
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Trial registration number | ACTRN12621000347864 |
Full text link
Last imported at : March 31, 2021, 4:03 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
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First author
Last imported at : March 31, 2021, 4:03 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
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Contact
Last imported at : March 31, 2021, 4:03 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
cleofas.rguez@gmail.com |
Registration date
Last imported at : March 31, 2021, 4:03 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
2021-03-26 |
Recruitment status
Last imported at : March 31, 2021, 4:03 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Not recruiting |
Study design
Last imported at : March 31, 2021, 4:03 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
RCT |
Allocation
Last imported at : March 31, 2021, 4:03 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Randomized |
Design
Last imported at : March 31, 2021, 4:03 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Parallel |
Masking
Last imported at : March 31, 2021, 4:03 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Blind label |
Center
Last imported at : March 31, 2021, 4:03 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
unclear |
Study aim
Last imported at : March 31, 2021, 4:03 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Treatment |
Inclusion criteria
Last imported at : March 31, 2021, 4:03 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Patients with COVID-19 positive polymerase chain reaction (PCR) test and/or Antygen-test more than 40 days ago. Physical sequelae related to deconditioning and fatigue |
Exclusion criteria
Last imported at : March 31, 2021, 4:03 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Patients with chronic lung conditions, chronic kidney disease, chronic neurological disorders. Patients suffering from hypertension and cardiovascular conditions without medical treatment. Patients affected with grade III osteoporosis, with acute phase of rheumatologic disorders, with acute phase of disc abnormalities. |
Number of arms
Last imported at : March 31, 2021, 4:03 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
2 |
Funding
Last imported at : March 31, 2021, 4:03 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
University of Seville |
Inclusion age min
Last imported at : March 31, 2021, 4:03 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
18 |
Inclusion age max
Last imported at : March 31, 2021, 4:03 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
75 |
Countries
Last imported at : March 31, 2021, 4:03 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Spain |
Type of patients
Last imported at : March 31, 2021, 4:03 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Mild disease at enrollment |
Severity scale
Last imported at : March 31, 2021, 4:03 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
1: Mild disease at enrollment |
Total sample size
Last imported at : March 31, 2021, 4:03 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
60 |
primary outcome
Last imported at : March 31, 2021, 4:03 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Thirty 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.[Days 0; 7; 14 post-intervention commencement]; 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. The BS will be completed by patients at the end of the test;( 30STST). Patients will send the results of BS screenshot to the evaluator; via WhatsApp or email.[Days 0; 7 and 14. post-intervention commencement];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 the patient’s 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.[Days 0; 7 and 14 post-intervention commencement] |
Notes
Last imported at : March 31, 2021, 4:03 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
|
Phase
Last imported at : March 31, 2021, 4:03 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Not reported |
Arms
Last imported at : March 31, 2021, 4:03 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
[{"arm_notes": "", "treatment_id": 1115, "treatment_name": "Respiratory tele-rehabilitation", "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"}] |