Clinical trial NCT06899698: INSPIRATORY MUSCLE TRAINER ON AUTONOMIC MODULATION AND PULMONARY FUNCTION
Official title: EFFECT OF INSPIRATORY MUSCLE TRAINER ON AUTONOMIC MODULATION AND PULMONARY FUNCTION IN PATIENTS WITH STROKE
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hemiplegic Stroke
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 60
Sex: MALE
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Brief summary; the purpose of the study is to evaluate the effect of inspiratory muscle trainer on autonomic modulation and pulmonary function in patients with stroke.

Good evidence exists that respiratory muscle strength is significantly impaired after stroke because of decreased cortico-respiratory outflow from the damaged cortex.

Inspiratory muscle training (IMT) improves the interplay of the respiratory pump, hemodynamic, cerebrovascular and postural balance responses.

Sixty chronic hemiplegic patients will be randomly allocated into; Study group will receive IMT, their medications in addition to the traditional training for eight weeks; Control group will receive their medications in addition to the traditional training for eight weeks.
Primary purpose: TREATMENT

Brief summary: Stroke individuals with hemiplegia often display difficulties in mobility, cardiopulmonary function...etc. All stroke patients had restrictive pulmonary dysfunction. Therefore, respiratory training improves their respiratory capacity, and orthostatic stress mediated respiratory, cardiovascular and autonomic response. Respiratory muscle training interventions are efficient in terms of pulmonary functional parameters. In advanced line, this study will be conducted to evaluate inspiratory muscle trainer effect on autonomic modulation and pulmonary function in stroke patients.

Detailed description: The second trigger of death and the most frequent life-threatening neurological disease are now strokes. Stroke is the third main cause of the death \& disability in Egypt. According to world health organization; from the total world's population, nearly 18.6 had severe disability and 79.7 million had moderate long-term disability. Respiratory dysfunction is a common complication of stroke, with an incidence of over 60%. Despite the high prevalence of stroke-induced respiratory dysfunction, how disordered breathing influences recovery and cognitive outcomes after ischemic stroke is unknown.

Patients with hemiplegia exhibited diminished respiratory muscle strength and pulmonary function at a more severe motor dysfunction level. Impaired inspiratory muscle strength was associated with reduced balance ability and limitations in activities required for daily living.

in the same line this study will be conducted to find out the effect of inspiratory muscle trainer on autonomic modulation and pulmonary function in patients with stroke.

Sixty chronic hemiplegic patients who aged from 55:65 years old will be recruited, and randomly divided into 2 equal groups; study group will receive threshold inspiratory muscle trainer for 8 weeks (24 sessions) and their medications, and traditional training, where control group will receive their prescribed medications in addition to the same traditional training.

Eligibility criteria: Inclusion Criteria:

* Chronic hemiplegic post stroke patients 'at least 6months'
* Men.
* Age ranged 55-65years old.
* Body mass index ranged from 29.9- 34.9 kg/m2
* Mini-Mental State Examination (MMSE) scores of 23-27 indicate mild cognitive impairment
* Did not participate in any selective exercise program for the respiratory muscles before.
* Participants suffering from orthostatic hypotension a systolic BP decline ≥20 mm Hg or a diastolic BP decline ≥10 mm Hg on position change from sitting to standing.

  * Smokers will be defined as those (who had smoked \>400 cigarettes in their lifetime)

Exclusion Criteria:

* Unstable cardiovascular problems.
* Asthmatic patient.
* Implanted pacemaker
* Patients with chest infection.
* Patients with pleural diseases.
* Primary valvular disease.
* History of spontaneous pneumothorax.
* Clinically significant peripheral vascular disease.
* Severe anemia being unable to follow RMT instructions or complete the questionnaires of the study due to cognitive impairment .
* Previous lung surgery.
* Long-term oxygen treatment.
* Patients with chronic renal failure.
* Any patient enrolled in an anther research study for at least 30 days.
* Facial affection

Primary outcomes:
measure: Blood Pressure
timeFrame: Pre-treatment, and Post-treatment of the 8-weeks of the study protocol (24 Sessions).
measure: Pulmonary Function test
timeFrame: Pre-treatment, and Post-treatment of the 8-weeks of the study protocol (24 Sessions).
Secondary outcomes:
measure: Functional capacity and orthostatic hypotension assessment
timeFrame: Pre-treatment, and Post-treatment of the 8-weeks of the study protocol (24 Sessions).
measure: Cognitive function
timeFrame: Pre-treatment, and Post-treatment of the 8-weeks of the study protocol (24 Sessions).
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Physical Therapy Faculty
state: Dokki
Study officials:
affiliation: Physical Therapy Faculty
name: Sara Mohamed Ahmed, Bachelor of Physical Therapy
role: PRINCIPAL_INVESTIGATOR
affiliation: Physical Therapy Faculty
name: Ebtesam Nabil Abdel Mohsen, Lecturer of Physical Therapy
role: STUDY_DIRECTOR
affiliation: faculty of medicine
name: Ebtesam Mohamed Fahmy, Professor of Neurology
role: STUDY_DIRECTOR
affiliation: faculty of physical therapy
name: Zeinab Mohamed Helmy, Professor of Physical Therapy
role: STUDY_CHAIR
References: