NCT06454539

The Effect of Functional Inspiratory Muscle Training Versus Inspiratory Muscle Training

The Effect of Functional Inspiratory Muscle Training Versus Inspiratory Muscle Training on Trunk Control and Respiratory Functions in Patients With Chronic Stroke

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Istinye University · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study aims to compare the effectiveness of functional inspiratory muscle training (IMT) versus inspiratory muscle training on trunk control, respiratory parameters, activity, and participation in chronic stroke patients. The study is a prospective, randomized, and parallel study. Forty-four stroke patients who meet the inclusion and exclusion criteria will be included in the study. The patients to be included in the study will be divided into equal numbers into two groups, F-IMT Group, and IMT Group, by block randomization method. Participants' trunk control will be measured with the Trunk Disability Scale and Trunk Control Test, respiratory parameters will be measured with respiratory muscle strength measurement test and respiratory function test, balance and gait will be measured with the Berg Balance Scale, and core muscle will be measured with pressurized biofeedback unit, exercise capacity will be measured by 6 minutes of walking. In the test, the level of independence in daily living activities will be evaluated with the Barthel Activities of Daily Living Index and treatment satisfaction with the Global Change Scale. Participants in the Functional IMT Group will perform supervised functional IMT 3 days a week, and IMT as a home program on 2 different days. In functional IMT, participants will perform breathing exercises with the device while simultaneously performing exercises based on the neurodevelopmental treatment approach given below. Exercises will be applied progressively, taking into account the functional status of stroke patients. Participants in the IMT Group will perform supervised exercises and IMT based on a neurodevelopmental treatment approach 3 days a week, and IMT as a home program on 2 different days.

Detailed description

This study aims to compare the effectiveness of functional inspiratory muscle training (IMT) versus inspiratory muscle training on trunk control, respiratory parameters, activity, and participation in chronic stroke patients. For this purpose, our hypotheses were determined as follows: H0: There is no difference between the effects of inspiratory muscle training and functional inspiratory muscle training applied in addition to the neurodevelopmental treatment approach in chronic stroke patients on trunk control, respiratory muscle strength, respiratory parameters, walking, balance, core muscles, functional capacity, daily living activities, and exercise adaptation. H1: There is a difference between the effects of inspiratory muscle training and functional inspiratory muscle training applied in addition to the neurodevelopmental treatment approach in chronic stroke patients on trunk control, respiratory muscle strength, respiratory parameters, walking, balance, core muscles, functional capacity, daily living activities and exercise adaptation. has. The study is a prospective, randomized, and parallel study. Forty-four stroke patients who meet the inclusion and exclusion criteria will be included in the study. The patients to be included in the study will be divided into equal numbers into two groups, F-IMT Group, and IMT Group, by block randomization method. Participants' trunk control will be measured with the Trunk Disability Scale and Trunk Control Test, respiratory parameters will be measured with respiratory muscle strength measurement test and respiratory function test, balance and gait will be measured with the Berg Balance Scale, and core muscle will be measured with pressurized biofeedback unit, exercise capacity will be measured by 6 minutes of walking. In the test, the level of independence in daily living activities will be evaluated with the Barthel Activities of Daily Living Index and treatment satisfaction with the Global Change Scale. Participants in the Functional IMT Group will perform supervised functional IMT 3 days a week, and IMT as a home program on 2 different days. In functional IMT, participants will perform breathing exercises with the device while simultaneously performing exercises based on the neurodevelopmental treatment approach given below. Exercises will be applied progressively, taking into account the functional status of stroke patients. Participants in the IMT Group will perform supervised exercises and IMT based on neurodevelopmental treatment approach 3 days a week, and IMT as a home program on 2 different days. Rehabilitation programs for stroke patients focus more on physical recovery and training on respiratory functions is kept in the background. It is expected that the inclusion of Functional IMT, an integrated exercise program that includes inspiratory muscle functions, in the rehabilitation programs of stroke patients will contribute to closing this gap. The unique value of our study is that it is conducted in stroke patients and compares the effects of Functional IMT and IMT. In light of the data obtained from the study, it is expected that Functional IMT can be used by physiotherapists in the clinic and will contribute to other possible research.

Conditions

• Respiratory Muscles
• Stroke

Interventions

Type	Name	Description
OTHER	Functional Inspiratory Muscle Training	Functional IMT is an inspiratory muscle training that ensures core stabilization and maintains postural control. Rhythmic co-contractions of the core muscle areas (diaphragm, transversus abdominis, multifidus, pelvic floor) ensure the stability of the trunk and provide it with the feature of being the support point of movement. In the first stage, the person is given core stabilization training. Secondly, core stabilization is maintained and continued with strong trunk activation exercises. Postural exercises reinforce the other function of the breathing muscles, which is actually 'core' stabilization.
OTHER	Inspiratory Muscle Training	Inspiratory muscle training (IMT) is one of the methods used to increase respiratory muscle strength. Different tools and methods (threshold resistive loading, normocapnic hyperpnea, and threshold pressure loading) have been developed for IMI. The most used method in the literature is the threshold pressure loading method. This method requires subjects to generate a negative pressure sufficient to overcome the load of the device and thus initiate inspiration. ICE is most commonly performed in a sitting position, with upper extremities supported and upper chest/shoulders relaxed. By placing the person in this position, the aim is for the respiratory muscles to focus only on the work of breathing.

Timeline

• Start date: 2024-06-15
• Primary completion: 2025-01-15
• Completion: 2025-03-15
• First posted: 2024-06-12
• Last updated: 2025-04-17

Locations

1 site across 1 country: Turkey (Türkiye)