The Effect of Functional Inspiratory Muscle Training Versus Inspiratory Muscle Training

NCT06454539 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-04-17

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Istinye University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-15
Primary Completion
2025-01-15
Completion
2025-03-15

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06454539 on ClinicalTrials.gov