NCT04949334

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 2, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

September 23, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2023

Completed
Last Updated

September 24, 2021

Status Verified

September 1, 2021

Enrollment Period

1.3 years

First QC Date

February 4, 2021

Last Update Submit

September 23, 2021

Conditions

Stroke, Ischemic

Keywords

StrokeRespiratory muscle trainingRespiratory function

Outcome Measures

Primary Outcomes (6)

  • Respiratory muscle function-1.1

    MEP (maximal expiratory pressure)

    Baseline

  • Respiratory muscle function-1.2

    MEP (maximal expiratory pressure)

    Within one week after training

  • Respiratory muscle function-1.3

    MEP (maximal expiratory pressure)

    Twelve weeks after training

  • Respiratory muscle function-2.1

    MIP (maximal inspiratory pressure)

    Baseline

  • Respiratory muscle function-2.2

    MIP (maximal inspiratory pressure)

    Within one week after training

  • Respiratory muscle function-2.3

    MIP (maximal inspiratory pressure)

    Twelve weeks after training

Secondary Outcomes (15)

  • Dyspnea.1

    Baseline

  • Dyspnea.2

    Within one week after training

  • Dyspnea.3

    Twelve weeks after training

  • Exercise tolerance.1

    Baseline

  • Exercise tolerance.2

    Within one week after training

  • +10 more secondary outcomes

Study Arms (2)

Dofin Breathing Strength Builder

EXPERIMENTAL

Usual post stroke care and respiratory muscle training

Device: Dofin Breathing Strength Builder

Usual post stroke care

NO INTERVENTION

Usual post stroke care

Interventions

Dofin Breathing Strength BuilderDEVICE

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.

Dofin Breathing Strength Builder

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ischemic stroke diagnosed by MRI
  • Age over 20 years old
  • No worsening of stroke or second stroke this time

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shuang Ho Hospital, Taipei Medical University

New Taipei City, 235, Taiwan

RECRUITING

MeSH Terms

Conditions

Ischemic StrokeStrokeRespiratory Aspiration

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Ruey Chen, PhD

CONTACT

886-2-224908818622@s.tmu.edu.tw

Tzu-Ang Chen, MD

CONTACT

886-915855505b101103035@tmu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

February 4, 2021

First Posted

July 2, 2021

Study Start

September 23, 2021

Primary Completion

January 15, 2023

Study Completion

July 15, 2023

Last Updated

September 24, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share

Locations

TW(1)