INSPIRATORY MUSCLE TRAINER ON AUTONOMIC MODULATION AND PULMONARY FUNCTION

NCT06899698 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005300
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiplegic Stroke

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Functional capacity and orthostatic hypotension assessment

  Pre-treatment, and Post-treatment of the 8-weeks of the study protocol (24 Sessions).

• Cognitive function

  Pre-treatment, and Post-treatment of the 8-weeks of the study protocol (24 Sessions).

Study Arms (2)

Study Group

EXPERIMENTAL

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; Other: Traditional Training

Control Group

OTHER

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

Interventions

Inspiratory muscle training 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.

Study Group

Traditional Training 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; Study Group

Eligibility Criteria

• Age: 55 Years - 65 Years
• Gender Eligibility Details: Men; their age range 55-65 years old suffering from chronic hemiplegic patients, their BMI ranged from 29.9- 34.9 kg/m2 , also with mild cognitive impairment
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Adly A Adam: lead

Study Sites (1)

Physical Therapy Faculty

Giza, Dokki, 12612, Egypt

Location

Study Officials

• Sara Mohamed Ahmed, Bachelor of Physical Therapy

  Physical Therapy Faculty

  PRINCIPAL INVESTIGATOR

• Ebtesam Nabil Abdel Mohsen, Lecturer of Physical Therapy

  Physical Therapy Faculty

  STUDY DIRECTOR

• Ebtesam Mohamed Fahmy, Professor of Neurology

  faculty of medicine

  STUDY DIRECTOR

• Zeinab Mohamed Helmy, Professor of Physical Therapy

  faculty of physical therapy

  STUDY CHAIR

Central Study Contacts

Sara Mohamed Ahmed, Bachalor

CONTACT

+2035676103; Info@pt.cu.edu.eg

Zeinab Mohamed Helmy, Professor of Physical Therapy

CONTACT

+2035676103; Info@pt.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of Physical Therapy

Model Details: 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.

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 28, 2025
• Study Start: April 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)