Trial document




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  DRKS00029206

Trial Description

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Title

Outpatient respiratory therapy for patients with post-COVID-19 syndrome - A feasibility study

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The purpose of this study is to test the feasibility of a large-scale study to measure the effects of respiratory therapy on post-COVID syndrome in affected patients. For this purpose, the planned study will be conducted in a smaller format. At the end, the recruitment process will be evaluated and the study participants (physiotherapists and patients) will be interviewed about their experiences with the study materials. In addition, a first effect assessment of the therapy on the post-COVID syndrome will be performed.

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Brief Summary in Scientific Language

In an explorative non-randomized and non-controlled longitudinal study with quantitative and qualitative data collection, physiotherapeutic respiratory therapy in patients with post-COVID syndrome will be observed over a period of nine weeks. Before and after the observation period, physiotherapeutic respiratory findings and assessments of fatigue, dyspnea, quality of life, activity and participation will be collected.
During the observation period, the implemented therapy contents and occurred adverse events will be documented. During and after the observation period, questionnaires and interviews will be used to assess aspects of the feasibility of a study and the provision of treatment (respiratory therapy). The study is coordinated by Heidelberg University Hospital.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00029206
  •   2022/06/17
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  •   yes
  •   Approved
  •   S-359/2022, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   ICD.10 U09.9G: Post-COVID-19 condition, unspecified.
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Interventions/Observational Groups

  •   Patients with post-COVID syndrome: observation of physiotherapeutic breathing therapy over a period of nine weeks.

    Before and after the observation period, physiotherapeutic respiratory findings and assessments of fatigue, dyspnea, quality of life, activity and participation will be collected.
    During the observation period, the implemented therapy contents and occurred adverse events are documented. During and after the observation period, aspects of the feasibility of a study and the provision of remedies (respiratory therapy) will be recorded by means of questionnaires and interviews.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

- recruitment (after completion of recruitment: qualitative survey by means of questionnaire and semi-structured interview).
- compliance (after application of the study documents: qualitative survey by means of questionnaire and semi-structured interview, quantitative survey by means of actual documentation on the documentation forms)
- potential effectiveness (after completion of the study: quantitative survey by means of documentation on the findings sheets and the questionnaires on fatique, dyspnea, activity and participation, and quality of life)

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Secondary Outcome

- respiratory therapy content
- safety of study content
- factors influencing access to care and respiratory therapy feasibility

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Planned
  •   2022/06/22
  •   30
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients:
Personal consent to participate in the study, good knowledge of German, onset of symptoms of COVID-19 disease more than twelve weeks ago, physician's prescription for physiotherapy with the diagnosis U09.9, persistent symptoms of post-COVID syndrome (primarily shortness of breath / problems with breathing).

Physical Therapists:
State-recognized professional title of physiotherapist, personal consent to participate in the study, good knowledge of German, work as a physiotherapist in an outpatient setting (practices/rehabilitation centers),
participation in the online information event to introduce the study and the study measures before study inclusion.

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Exclusion Criteria

Patients:
Poor general health (which does not allow for outpatient treatment), need for home visits, limitations (which do not allow the patient to complete the questionnaires independently, such as dementia), severe lung disease (such as COPD), severe mental illness.

Physical Therapists:
Physical therapists who have had their professional title revoked and/or are unauthorized to use it.

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Addresses

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Sources of Monetary or Material Support

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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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