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Trial - NCT05121688


Column Value
Trial registration number NCT05121688
Full text link
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

First author
Last imported at : May 12, 2023, noon
Source : ClinicalTrials.gov

María José Díaz-Arribas

Contact
Last imported at : May 12, 2023, noon
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

2021-11-16

Recruitment status
Last imported at : May 12, 2023, noon
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

Long covid

Inclusion criteria
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

inclusion criteria: patients with long post-covid symptoms (from week 12 to week 24). patients between 25 and 70 years old. patients with moderate respiratory and/or functional affectation with long post covid-19 symptoms, belonging to four physiotherapy units of primary health care in madrid (spain). confirmed diagnosis of covid-19 via a positive nasopharyngeal or throat swab within the past 12 months. persistent symptoms lasting ≥12 weeks since the first positive test, including dyspnea (new or increased from baseline as measured by modified medical research council (mmrc) score ≥1). normal oxygen saturation (greater than 90%) by pulse oximetry at rest on room air. participant owns a smart phone, tablet, or computer to access on-line sessions.

Exclusion criteria
Last imported at : May 12, 2023, noon
Source : ClinicalTrials.gov

people with symptoms such as fever, cough, upper respiratory distress, diarrhea, vomiting, anosmia or ageusia. temperature greater than 37.2 degrees celsius. patients with multimorbidity. multimorbidity will be considered when the patient is diagnosed with two or more diseases among the following: diabetes, dyslipidaemia, cardiovascular disease (arterial hypertension, ischemic heart disease, valvular heart disease, heart failure), osteoarthritis, respiratory disease (asthma, chronic bronchitis), digestive disease ( gastric or duodenal ulcers, inflammatory bowel disease, liver disease), psychiatric pathology or tumor pathology. patients with previous pathologies: ischemic heart disease, dementia, lung failure, lung cancer, cystic fibrosis, pulmonary fibrosis, chronic kidney failure, liver diseases, myocardial arrhythmias, deep vein thrombosis, severe aortic stenosis, liver diseases. patients with weakened immune systems: in cancer treatment, organ or marrow transplant patients, hiv/aids, prolonged use of prednisone or similar medication. patients with functional limitations to carry out their basic activities of daily living. barthel index greater than 90. patients with cognitive problems. mini-cognitive lobo exam greater than 23 points active bleeding. unstable fractures.

Number of arms
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

Universidad Complutense de Madrid

Inclusion age min
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

20

Inclusion age max
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

75

Countries
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

Spain

Type of patients
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

Patients recovered from covid

Severity scale
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

71

primary outcome
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

Modified Borg scale.;Modified Borg scale.;Modified Borg scale.;Modified Borg scale.

Notes
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

Not reported

Arms
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 990, "treatment_name": "Physiotherapy", "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"}]