Effects of Respiratory Muscle Training in Patients With Acute Ischemic Stroke
23. september 2021 oppdatert av: Chen ruey, Taipei Medical University Shuang Ho Hospital
After acute ischemic stroke, the muscle strength of the limbs of the patients will decrease.
Moreover, the respiratory muscles may also be affected.
The respiratory muscle training may improve the respiratory recovery and prevent pulmonary complication.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
After acute ischemic stroke, the muscle strength of the limbs of the patients will decrease.
Moreover, the respiratory muscles may also be affected.
The worsening of the respiratory function is weakened and lung function declines, leading to dysfunction of expectoration and swallowing, and increasing the incidence of pneumonia after stroke.
In addition, it will also lead to a decline in activity ability, which in turn affects the quality of life.
The respiratory muscle training may improve the respiratory recovery and prevent pulmonary complication.
Studietype
Intervensjonell
Registrering (Forventet)
144
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Ruey Chen, PhD
- Telefonnummer: 8620 886-2-2249088
- E-post: 18622@s.tmu.edu.tw
Studer Kontakt Backup
- Navn: Tzu-Ang Chen, MD
- Telefonnummer: 886-915855505
- E-post: b101103035@tmu.edu.tw
Studiesteder
-
-
-
New Taipei City, Taiwan, 235
- Rekruttering
- Shuang Ho Hospital, Taipei Medical University
-
Ta kontakt med:
- Ruey Chen, PhD
- Telefonnummer: 8620 886-2-2249088
- E-post: 18622@s.tmu.edu.tw
-
Ta kontakt med:
- Tzu-Ang Chen, MD
- Telefonnummer: 886-915855505
- E-post: b101103035@tmu.edu.tw
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
20 år til 90 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Ischemic stroke diagnosed by MRI
- Age over 20 years old
- No worsening of stroke or second stroke this time
Exclusion Criteria:
- Unable to understand instructions normally, or communication difficulties
- Patients with endotracheal tube or tracheostomy
- Angina in recent 3 months, myocardial infarction, heart failure
- Patients with asthma or chronic obstructive pulmonary disease, spontaneous pneumothorax, and ongoing pneumonia
- Patients with untreated hernias
- Pregnant
- Ongoing fever (body temperature>38.5°C)
- Poor hypertension control (higher than 170/100 mmHg three days before intervention)
- Patients who have had cerebral hemorrhage or aneurysm
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Dofin Breathing Strength Builder
Usual post stroke care and respiratory muscle training
|
If the patient's condition is stable, respiratory muscle training will be performed under Dofin Breathing Strength Builder 7 days after stroke. The patient will receive respiratory muscle training by repetition of 30 times, two courses per day, x 7 days, for three weeks. The initial load was set at 30% of the participants' maximal baseline strength and increased weekly at intervals of 2 cmH2O. |
|
Ingen inngripen: Usual post stroke care
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Respiratory muscle function-1.1
Tidsramme: Baseline
|
MEP (maximal expiratory pressure)
|
Baseline
|
|
Respiratory muscle function-1.2
Tidsramme: Within one week after training
|
MEP (maximal expiratory pressure)
|
Within one week after training
|
|
Respiratory muscle function-1.3
Tidsramme: Twelve weeks after training
|
MEP (maximal expiratory pressure)
|
Twelve weeks after training
|
|
Respiratory muscle function-2.1
Tidsramme: Baseline
|
MIP (maximal inspiratory pressure)
|
Baseline
|
|
Respiratory muscle function-2.2
Tidsramme: Within one week after training
|
MIP (maximal inspiratory pressure)
|
Within one week after training
|
|
Respiratory muscle function-2.3
Tidsramme: Twelve weeks after training
|
MIP (maximal inspiratory pressure)
|
Twelve weeks after training
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Dyspnea.1
Tidsramme: Baseline
|
Dyspnea assessed by Modified Borg Dyspnea Scale (MBS).
MBS can go from 0-10, 10 is the more severe condition.
|
Baseline
|
|
Dyspnea.2
Tidsramme: Within one week after training
|
Dyspnea assessed by Modified Borg Dyspnea Scale (MBS).
MBS can go from 0-10, 10 is the more severe condition.
|
Within one week after training
|
|
Dyspnea.3
Tidsramme: Twelve weeks after training
|
Dyspnea assessed by Modified Borg Dyspnea Scale (MBS).
MBS can go from 0-10, 10 is the more severe condition.
|
Twelve weeks after training
|
|
Exercise tolerance.1
Tidsramme: Baseline
|
Exercise tolerance assessed by six-minute walk test (6MWT).
|
Baseline
|
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Exercise tolerance.2
Tidsramme: Within one week after training
|
Exercise tolerance assessed by six-minute walk test (6MWT).
|
Within one week after training
|
|
Exercise tolerance.3
Tidsramme: Twelve weeks after training
|
Exercise tolerance assessed by six-minute walk test (6MWT).
|
Twelve weeks after training
|
|
Body composition.1
Tidsramme: Baseline
|
Body composition including body fat and muscle mass measured by multi frequency segmental body composition analyzer (TANITA).
|
Baseline
|
|
Body composition.2
Tidsramme: Within one week after training
|
Body composition including body fat and muscle mass measured by multi frequency segmental body composition analyzer (TANITA).
|
Within one week after training
|
|
Body composition.3
Tidsramme: Twelve weeks after training
|
Body composition including body fat and muscle mass measured by multi frequency segmental body composition analyzer (TANITA).
|
Twelve weeks after training
|
|
Life quality.1
Tidsramme: Baseline
|
Quality of life assessed by Short-form 12 (SF-12).
SF-12 can go from 0-100, 100 is the better life quality.
|
Baseline
|
|
Life quality.2
Tidsramme: Within one week after training
|
Quality of life assessed by Short-form 12 (SF-12).
SF-12 can go from 0-100, 100 is the better life quality.
|
Within one week after training
|
|
Life quality.3
Tidsramme: Twelve weeks after training
|
Quality of life assessed by Short-form 12 (SF-12).
SF-12 can go from 0-100, 100 is the better life quality.
|
Twelve weeks after training
|
|
Swallowing.1
Tidsramme: Baseline
|
Swallowing function assessed by the Functional Oral Intake Scale (FOIS).
The score can go from 1-7, 7 is the better oral intake condition.
|
Baseline
|
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Swallowing.2
Tidsramme: Within one week after training
|
Swallowing function assessed by the Functional Oral Intake Scale (FOIS).
The score can go from 1-7, 7 is the better oral intake condition.
|
Within one week after training
|
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Swallowing.3
Tidsramme: Twelve weeks after training
|
Swallowing function assessed by the Functional Oral Intake Scale (FOIS).
The score can go from 1-7, 7 is the better oral intake condition.
|
Twelve weeks after training
|
Samarbeidspartnere og etterforskere
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
23. september 2021
Primær fullføring (Forventet)
15. januar 2023
Studiet fullført (Forventet)
15. juli 2023
Datoer for studieregistrering
Først innsendt
4. februar 2021
Først innsendt som oppfylte QC-kriteriene
24. juni 2021
Først lagt ut (Faktiske)
2. juli 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. september 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. september 2021
Sist bekreftet
1. september 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- N202009012
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