INSPIRATORY MUSCLE TRAINER ON AUTONOMIC MODULATION AND PULMONARY FUNCTION

EFFECT OF INSPIRATORY MUSCLE TRAINER ON AUTONOMIC MODULATION AND PULMONARY FUNCTION IN PATIENTS WITH STROKE

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hemiplegic Stroke
• Intervention / Treatment: Other: Inspiratory muscle training; Other: Traditional Training

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara Mohamed Ahmed, Bachalor; Phone Number: 103 +2035676103; Email: Info@pt.cu.edu.eg
• Study Contact Backup: Name: Zeinab Mohamed Helmy, Professor of Physical Therapy; Phone Number: 103 +2035676103; Email: Info@pt.cu.edu.eg

Study Locations

• Egypt
  • Dokki
    • Giza, Dokki, Egypt, 12612
      • Physical Therapy Faculty
      • Contact: Zeinab Mohamed Helmy, Professor of Physical Thera[y/; Phone Number: 103 +2035676103; Email: Info@pt.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Group; Thirty chronic hemiplegic patients with mild cognitive impairment, and suffering from orthostatic hypotension will receive inspiratory muscle training for 30 minutes per day for at least 3 days a week for 8 weeks, medications, and traditional training along 8 weeks.	Other: Inspiratory muscle training; Only participants in the Study group 'Thirty chronic hemiplegic patients with mild cognitive impairment, and suffering from orthostatic hypotension' will receive inspiratory muscle training using Respiratory muscle strength: Threshold Inspiratory muscle trainer (TIMT): Philips Respironics model (Tayland- B00J417PHM), for 30 minutes per day for at least 3 days a week for 8 weeks.; Other: Traditional Training; Both the study and control group 'Sixty chronic hemiplegic patients with mild cognitive impairment, and suffering from orthostatic hypotension' will receive a. bobath technique 'passive mobilization associated with tactile and proprioceptive stimuli aims to inhibits spasticity'; b. Proprioceptive neuromuscular facilitation 'based on spiral and diagonal patterns of movements in line to achieve normal movements' c. Rood technique 'focuses on the developmental sequence of recovery (from basic to complex) and the use of sensory stimulation to facilitate movement and postural responses' d. Johnstone method 'includes positioning and splinting to inhibit abnormal patterns and controlling tone to restore central control' e. Functional electrical stimulation; f. Balance training, j. Pelvic, and gait training, h. Activities of daily living, and finally, g. Sensrimotor training 'Active and active-assistive range-of motion exercises, Graded activities Start with easy activities'.
Other: Control Group; Thirty chronic hemiplegic patients with mild cognitive impairment, and suffering from orthostatic hypotension will receive their medications, and traditional training along 8 weeks.	Other: Traditional Training; Both the study and control group 'Sixty chronic hemiplegic patients with mild cognitive impairment, and suffering from orthostatic hypotension' will receive a. bobath technique 'passive mobilization associated with tactile and proprioceptive stimuli aims to inhibits spasticity'; b. Proprioceptive neuromuscular facilitation 'based on spiral and diagonal patterns of movements in line to achieve normal movements' c. Rood technique 'focuses on the developmental sequence of recovery (from basic to complex) and the use of sensory stimulation to facilitate movement and postural responses' d. Johnstone method 'includes positioning and splinting to inhibit abnormal patterns and controlling tone to restore central control' e. Functional electrical stimulation; f. Balance training, j. Pelvic, and gait training, h. Activities of daily living, and finally, g. Sensrimotor training 'Active and active-assistive range-of motion exercises, Graded activities Start with easy activities'.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure	systolic, diastolic blood pressure and mean arterial blood pressure those will be measure using Mercury sphygmomanometer and stethoscope (China ,1600G004).	Pre-treatment, and Post-treatment of the 8-weeks of the study protocol (24 Sessions).
Pulmonary Function test	Pulmonary function test using Spirometry will be used to evaluate (Compact; Vitalograph; Buckingham, England) FVC, FEV1, FEV1 / FVC will be measured three times per each time of evaluation on a computerized spirometer	Pre-treatment, and Post-treatment of the 8-weeks of the study protocol (24 Sessions).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional capacity and orthostatic hypotension assessment	Sit to stand test will be used for functional capacity assessment in addition to assessing the blood pressure from sitting to standing positions before and after treatment	Pre-treatment, and Post-treatment of the 8-weeks of the study protocol (24 Sessions).
Cognitive function	Cognitive function will be assessed using the Mini-Mental State Examination (MMSE) scores that is a tool that can be used to systematically and thoroughly assess mental status. It is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The maximum score is 30. A score of 23 or lower is indicative of cognitive impairment. The MMSE takes only 5-10 minutes to administer and is therefore practical to use repeatedly and routinely.	Pre-treatment, and Post-treatment of the 8-weeks of the study protocol (24 Sessions).

Collaborators and Investigators

• Sponsor: Adly A Adam
• Investigators: Principal Investigator: Sara Mohamed Ahmed, Bachelor of Physical Therapy, Physical Therapy Faculty; Study Director: Ebtesam Nabil Abdel Mohsen, Lecturer of Physical Therapy, Physical Therapy Faculty; Study Director: Ebtesam Mohamed Fahmy, Professor of Neurology, Faculty of medicine; Study Chair: Zeinab Mohamed Helmy, Professor of Physical Therapy, Faculty of Physical Therapy

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 20, 2025
• First Submitted That Met QC Criteria: March 26, 2025
• First Posted (Actual): March 28, 2025

Study Record Updates

• Last Update Posted (Actual): March 28, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: P.T.REC/012/005300

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No