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Trial - DRKS00028275


Column Value
Trial registration number DRKS00028275
Full text link
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

First author
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Anke Steinmetz

Contact
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

anke.steinmetz@med.uni-greifswald.de

Registration date
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2022-03-30

Recruitment status
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not recruiting

Study design
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

RCT

Allocation
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Randomized

Design
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Parallel

Masking
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Open label

Center
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

multi-center

Study aim
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Long covid

Inclusion criteria
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

- Age >= 18 years- History of COVID-19 disease (PCR-confirmed) at least 4-6 weeks prior to study inclusion- COVID-19 associated respiratory dysfunction (shortness of breath, dyspnoea, respiratory rate increase)- Sufficient knowledge of German as mother tongue or foreign language level at least CI- Written consent for study participation- indication for outpatient or inpatient therapy

Exclusion criteria
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

- Acute COVID-19 disease- Patients with marked pulmonary fibrosis or other structural lung changes with functional impact after COVID-19 disease.- Chronic pulmonary disease prior to COVID-19 (asthma, CORD etc.)- Pre-existing or COVID-19 neurological disease with impact on respiratory function- Patients ventilated in the acute situation with abnormal laryngoscopic findings- Acute laryngitis

Number of arms
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2

Funding
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Universitätsmedizin Greifswald/ Unfallkrankenhaus Berlin

Inclusion age min
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

18

Inclusion age max
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

100

Countries
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Germany

Type of patients
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Patients recovered from covid

Severity scale
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

N/A

Total sample size
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

40

primary outcome
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Respiratory parameters (Bodyplethymography) at rest and after exercise using a 6-minute walk test and phonation.

Notes
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

| Declared number of arm (2.0) differs from found arms (3.0)

Phase
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not reported

Arms
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

[{"arm_notes": "Vocal-based respiratory therapy with short-phrase/strengthening vocal elements", "treatment_id": 2431, "treatment_name": "Vocal-based respiratory therapy", "treatment_type": "Rehabilitation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "Vocal-based respiratory therapy with toned increases in phrasing length", "treatment_id": 2431, "treatment_name": "Vocal-based respiratory therapy", "treatment_type": "Rehabilitation", "pharmacological_treatment": "Non pharmacological treatment"}]