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Trial - NCT04881214


Column Value
Trial registration number NCT04881214
Full text link
Last imported at : May 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04881214

First author
Last imported at : Sept. 24, 2022, 4:30 a.m.
Source : ClinicalTrials.gov

Frédéric Lador

Contact
Last imported at : Sept. 24, 2022, 4:30 a.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : May 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-05-11

Recruitment status
Last imported at : Sept. 24, 2022, 4:30 a.m.
Source : ClinicalTrials.gov

Not recruiting

Study design
Last imported at : May 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : May 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : May 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : May 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Open label

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

single-center

Study aim
Last imported at : May 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Long covid

Inclusion criteria
Last imported at : May 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

patients will be eligible for inclusion if they fulfil all the following criteria: - patients aged ≥ 18 years. - confirmed diagnosis of sars-cov-2 infection by nasal swab, other viral sample (i.e. sputum, bronchoalveolar lavage) or chest imaging suggestive of sars-cov-2 pneumonia (chest x-ray or ct-scan). - requirement for oxygen supplementation. - persistent respiratory symptoms (i.e. dyspnoea, cough) or asthenia. - abnormal 6mwt at 3 months (distance < 90% predicted or desaturation ≥ 3% or borg >5) and/or abnormal lung function as described by the international recommendations patients will be excluded if they: - already had existing severe and symptomatic pulmonary condition before covid-19 pneumonia - are unable to execute the different tests and surveys because of cognitive or physical limitations. - are already included in a structured rehabilitation program - have comorbidities with a life expectancy of less than 12 months. - any relevant acute medical disorder/acute disease state judged by the investigators as likely to represent a risk for the patient to fulfil a rehabilitation program or requiring urgent investigations.

Exclusion criteria
Last imported at : May 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

None

Number of arms
Last imported at : May 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : May 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

University Hospital, Geneva

Inclusion age min
Last imported at : May 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : May 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : May 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Switzerland

Type of patients
Last imported at : May 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Patients recovered from covid

Severity scale
Last imported at : May 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : May 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

60

primary outcome
Last imported at : May 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Effect of ambulatory pulmonary rehabilitation in health related quality of life

Notes
Last imported at : May 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Not reported

Arms
Last imported at : May 13, 2021, 12:31 a.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"}]