Tele-coaching in Patients With COVID-19
9. marts 2021 opdateret af: Ilknur Naz, Izmir Katip Celebi University
Effectiveness of Pulmonary Rehabilitation With Tele-coaching in Patients With COVID-19
Respiratory exercise training and aerobic exercise training will be given to patients who have been hospitalized in intensive care due to COVID 19 and underwent IMV, who were hospitalized in the service and underwent NIMV or high-flow oxygen inhalation, and whose respiratory symptoms persist after discharge.
The patients in the study group will be called by phone once a week and a motivating conversation will be made.
No control will be made to the control group.
Before and after the training, 6-minute walking test, MRC dyspnea scale, SGRQ quality of life questionnaire and hospital anxiety depression scale will be applied.
Studieoversigt
Detaljeret beskrivelse
Some of the patients with COVID 19 pneumonia still have respiratory symptoms despite being treated.
It has been reported that pulmonary rehabilitation programs applied in various models and in a small number to relieve or reduce these symptoms reduce dyspnea, increase exercise capacity and improve quality of life.
There is no study reporting the results of a pulmonary rehabilitation program applied to COVID 19 patients in our country.
The main purpose of this study is to determine the efficacy of pulmonary rehabilitation applied by telecoach to patients with severe COVID 19 pneumonia or persistent respiratory symptoms.
Secondly, it is aimed to present the data of Turkish society to the literature.
In accordance with this purpose investigators planed a randomised control clinical study.
In our study respiratory exercise training and aerobic exercise training will be given to patients who have been hospitalized in intensive care due to COVID 19 and underwent IMV, who were hospitalized in the service and underwent NIMV or high-flow oxygen inhalation, and whose respiratory symptoms persist after discharge.
The patients in the study group will be called by phone once a week and a motivating conversation will be made.
No control will be made to the control group.
Before and after the training, 6-minute walking test, MRC dyspnea scale, SGRQ quality of life questionnaire and hospital anxiety depression scale will be applied.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
36
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Being treated in intensive care unit due to COVID-19 pneumonia,
- Receiving IMV, NIMV, or high-flow oxygen therapy
- Patients whose respiratory symptoms persist despite discharge
Exclusion Criteria:
- Patients with PCR test +
- Patients without any complaints.
- Patients who are hospitalized and discharged within 10 days
- Patients with orthopedic, neurological, cognitive problems
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Telecoaching group
They will be given breathing exercise training and will be asked to do it every day for 8 weeks.
In addition to breathing exercises, the use of incentive spirometry and aerobic exercise training will be provided.
They will be asked to do breathing exercises, use of incentive spirometry and strengthening exercises for at least 20 minutes every day and 5 times a week.
They will be called by phone once a week and encouraging speeches will be made.
|
Breathing exercise training Use of incentive spirometry Aerobic exercise training Strengthening exercises
|
|
Aktiv komparator: Control Group
They will be given breathing exercise training and will be asked to do it every day.
In addition to breathing exercises, the use of incentive spirometry and aerobic exercise training will be provided.
They will be asked to do breathing exercises, use of incentive spirometry and strengthening exercises for at least 20 minutes every day and 5 times a week.
There will be no interviews in the control group.
|
Breathing exercise training Use of incentive spirometry Aerobic exercise training Strengthening exercises
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Exercise Capacity
Tidsramme: Change from baseline six minute walk distance at 8 week
|
Six Minute- walk test
|
Change from baseline six minute walk distance at 8 week
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Dyspnøvurdering
Tidsramme: Ændring fra baseline dyspnø ved 8 uge
|
Medical Research Council Scale (MRC); MRC dyspnøskalaen er et spørgeskema, der består af fem udsagn om opfattet åndenød.
(min 1- max 5 point) Højere score betyder et dårligere resultat.
|
Ændring fra baseline dyspnø ved 8 uge
|
|
Quality of Life Assessment
Tidsramme: Change from baseline quality of life at 8 week
|
St. George Respiratory Questionnaire; Scores range from 0 to 100, with higher scores indicating more limitations.
|
Change from baseline quality of life at 8 week
|
|
Anxiety and Depression
Tidsramme: Change from baseline anxiety and depression at 8 week
|
Hospital Anxiety and Depression (HAD); The HADS questionnaire has seven items each for depression and anxiety subscales.
Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level.
A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety or depression.
|
Change from baseline anxiety and depression at 8 week
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
1. marts 2021
Primær færdiggørelse (Forventet)
1. marts 2021
Studieafslutning (Forventet)
1. marts 2021
Datoer for studieregistrering
Først indsendt
27. februar 2021
Først indsendt, der opfyldte QC-kriterier
9. marts 2021
Først opslået (Faktiske)
10. marts 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. marts 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. marts 2021
Sidst verificeret
1. marts 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IKCSS
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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