INSPIRATORY MUSCLE TRAINER ON AUTONOMIC MODULATION AND PULMONARY FUNCTION

NCT ID: NCT06899698

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2025-12-01

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.

Conditions

Hemiplegic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Inspiratory muscle training

Intervention Type: OTHER

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.

Traditional Training

Intervention Type: OTHER

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'.

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.

Group Type: OTHER

Traditional Training

Intervention Type: OTHER

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'.

Interventions

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.

Intervention Type: 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'.

Intervention Type: OTHER

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Adly A Adam

OTHER

Sponsor Role: lead

Responsible Party

Adly A Adam

Lecturer of Physical Therapy

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sara Mohamed Ahmed, Bachelor of Physical Therapy

Role: PRINCIPAL_INVESTIGATOR

Physical Therapy Faculty

Ebtesam Nabil Abdel Mohsen, Lecturer of Physical Therapy

Role: STUDY_DIRECTOR

Physical Therapy Faculty

Ebtesam Mohamed Fahmy, Professor of Neurology

Role: STUDY_DIRECTOR

faculty of medicine

Zeinab Mohamed Helmy, Professor of Physical Therapy

Role: STUDY_CHAIR

faculty of physical therapy

Locations

Physical Therapy Faculty

Giza, Dokki, Egypt

Countries

Egypt

Central Contacts

Sara Mohamed Ahmed, Bachalor

Role: CONTACT

Info@pt.cu.edu.eg

+2035676103 ext. 103

Zeinab Mohamed Helmy, Professor of Physical Therapy

Role: CONTACT

Info@pt.cu.edu.eg

+2035676103 ext. 103

Facility Contacts

Zeinab Mohamed Helmy, Professor of Physical Thera[y/

Role: primary

Info@pt.cu.edu.eg

+2035676103 ext. 103

Other Identifiers

P.T.REC/012/005300

Identifier Type: -

Identifier Source: org_study_id