Clinical trial NCT04949334: Effects of Respiratory Muscle Training in Patients With Acute Ischemic Stroke
Official title: Effects of Respiratory Muscle Training in Patients With Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke, Ischemic
Keywords: Stroke
Respiratory muscle training
Respiratory function
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 144
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Ischemic stroke diagnosed by MRI
2. Age over 20 years old
3. No worsening of stroke or second stroke this time

Exclusion Criteria:

1. Unable to understand instructions normally, or communication difficulties
2. Patients with endotracheal tube or tracheostomy
3. Angina in recent 3 months, myocardial infarction, heart failure
4. Patients with asthma or chronic obstructive pulmonary disease, spontaneous pneumothorax, and ongoing pneumonia
5. Patients with untreated hernias
6. Pregnant
7. Ongoing fever (body temperature\>38.5°C)
8. Poor hypertension control (higher than 170/100 mmHg three days before intervention)
9. Patients who have had cerebral hemorrhage or aneurysm

Primary outcomes:
measure: Respiratory muscle function-1.1
timeFrame: Baseline
measure: Respiratory muscle function-1.2
timeFrame: Within one week after training
measure: Respiratory muscle function-1.3
timeFrame: Twelve weeks after training
measure: Respiratory muscle function-2.1
timeFrame: Baseline
measure: Respiratory muscle function-2.2
timeFrame: Within one week after training
measure: Respiratory muscle function-2.3
timeFrame: Twelve weeks after training
Secondary outcomes:
measure: Dyspnea.1
timeFrame: Baseline
measure: Dyspnea.2
timeFrame: Within one week after training
measure: Dyspnea.3
timeFrame: Twelve weeks after training
measure: Exercise tolerance.1
timeFrame: Baseline
measure: Exercise tolerance.2
timeFrame: Within one week after training
measure: Exercise tolerance.3
timeFrame: Twelve weeks after training
measure: Body composition.1
timeFrame: Baseline
measure: Body composition.2
timeFrame: Within one week after training
measure: Body composition.3
timeFrame: Twelve weeks after training
measure: Life quality.1
timeFrame: Baseline
measure: Life quality.2
timeFrame: Within one week after training
measure: Life quality.3
timeFrame: Twelve weeks after training
measure: Swallowing.1
timeFrame: Baseline
measure: Swallowing.2
timeFrame: Within one week after training
measure: Swallowing.3
timeFrame: Twelve weeks after training
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Shuang Ho Hospital, Taipei Medical University
Study officials:
References: