Effects of Respiratory Muscle Training in Patients With Acute Ischemic Stroke
23. september 2021 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
144
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Ruey Chen, PhD
- Telefonnummer: 8620 886-2-2249088
- E-mail: 18622@s.tmu.edu.tw
Undersøgelse Kontakt Backup
- Navn: Tzu-Ang Chen, MD
- Telefonnummer: 886-915855505
- E-mail: b101103035@tmu.edu.tw
Studiesteder
-
-
-
New Taipei City, Taiwan, 235
- Rekruttering
- Shuang Ho Hospital, Taipei Medical University
-
Kontakt:
- Ruey Chen, PhD
- Telefonnummer: 8620 886-2-2249088
- E-mail: 18622@s.tmu.edu.tw
-
Kontakt:
- Tzu-Ang Chen, MD
- Telefonnummer: 886-915855505
- E-mail: b101103035@tmu.edu.tw
-
-
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
20 år til 90 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
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: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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 indgriben: Usual post stroke care
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
|
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
|
|
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
|
|
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
|
Samarbejdspartnere og efterforskere
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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 (Faktiske)
23. september 2021
Primær færdiggørelse (Forventet)
15. januar 2023
Studieafslutning (Forventet)
15. juli 2023
Datoer for studieregistrering
Først indsendt
4. februar 2021
Først indsendt, der opfyldte QC-kriterier
24. juni 2021
Først opslået (Faktiske)
2. juli 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. september 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. september 2021
Sidst verificeret
1. september 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- N202009012
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