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

Overview

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.

Interventions

• 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 co

Primary outcome measures

• Blood Pressure [Time frame: Pre-treatment, and Post-treatment of the 8-weeks of the study protocol (24 Sessions).]
• Pulmonary Function test [Time frame: Pre-treatment, and Post-treatment of the 8-weeks of the study protocol (24 Sessions).]

Secondary outcome measures (2)

• Functional capacity and orthostatic hypotension assessment [Time frame: Pre-treatment, and Post-treatment of the 8-weeks of the study protocol (24 Sessions).]
• Cognitive function [Time frame: Pre-treatment, and Post-treatment of the 8-weeks of the study protocol (24 Sessions).]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Physical Therapy Faculty — Giza

Identifiers

NCT: NCT06899698 · P.T.REC/012/005300

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗