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Trial - NCT05244044


Column Value
Trial registration number NCT05244044
Full text link
Last imported at : Feb. 18, 2022, 5 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05244044

First author
Last imported at : Aug. 2, 2023, 8 p.m.
Source : ClinicalTrials.gov

None

Contact
Last imported at : Aug. 2, 2023, 8 p.m.
Source : ClinicalTrials.gov

None

Registration date
Last imported at : Feb. 18, 2022, 5 p.m.
Source : ClinicalTrials.gov

2022-02-17

Recruitment status
Last imported at : Aug. 2, 2023, 8 p.m.
Source : ClinicalTrials.gov

Not recruiting

Study design
Last imported at : Feb. 18, 2022, 5 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Feb. 18, 2022, 5 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Feb. 18, 2022, 5 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Feb. 18, 2022, 5 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : Feb. 18, 2022, 5 p.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Feb. 18, 2022, 5 p.m.
Source : ClinicalTrials.gov

Long covid

Inclusion criteria
Last imported at : April 12, 2023, 4 a.m.
Source : ClinicalTrials.gov

inclusion criteria: adult patients with status post covid-19 (positive covid-19 pcr or an official pharmacy performed antigen test or a self-performed test confirmed by a physician during the acute covid-19 ≥ 6 weeks ago or positive antibodies before vaccination or positive antibodies before vaccination). persistent covid related symptoms that were not present pre-covid-19 or were less severe pre-covid. symptomatic: quantified by dyspnea on exertion, loss of energy, fatigue or sleep impairment based upon the score of four questionnaires: copd assessment test (cat) ≥10, and/or modified medical research council dyspnea scale (mmrc) ≥2, and/or cis-fatigue ≥36, and/or post-covid-19 functional status (pcfs) ≥2.

Exclusion criteria
Last imported at : April 12, 2023, 4 a.m.
Source : ClinicalTrials.gov

patients with known or self-reported cognitive, hearing, visual, neurological or musculoskeletal conditions that make it impossible to participate in pulmonary rehabilitation. prior physiotherapy for long covid if: patients who have completed ≥9 sessions of physiotherapy in total for long covid. patients who completed any physiotherapy session in the previous 12 weeks for long covid (primary care or hospital based; pulmonary or non-pulmonary). patients with predominantly neurological disorders impacting respiratory function will not be eligible for the study. patients that are not able to give informed consent or not able to complete questionnaires. patients who have had any organ transplatation in the past, have to undergo any transplantation or are on an active transplantation list. patients with active malignancy and/or (maintenance) treatment for active malignancy or curatively treated carcinoma within the past year.

Number of arms
Last imported at : Feb. 18, 2022, 5 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Feb. 18, 2022, 5 p.m.
Source : ClinicalTrials.gov

University Hospital, Antwerp

Inclusion age min
Last imported at : Feb. 18, 2022, 5 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Feb. 18, 2022, 5 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Feb. 18, 2022, 5 p.m.
Source : ClinicalTrials.gov

Belgium

Type of patients
Last imported at : Feb. 18, 2022, 5 p.m.
Source : ClinicalTrials.gov

Patients recovered from covid

Severity scale
Last imported at : Feb. 18, 2022, 5 p.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Aug. 2, 2023, 8 p.m.
Source : ClinicalTrials.gov

76

primary outcome
Last imported at : Feb. 18, 2022, 5 p.m.
Source : ClinicalTrials.gov

Exercise capacity

Notes
Last imported at : Feb. 18, 2022, 5 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 18, 2022, 5 p.m.
Source : ClinicalTrials.gov

Not reported

Arms
Last imported at : Feb. 18, 2022, 5 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 1043, "treatment_name": "Pulmonary 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"}]