Clinical trial NCT06454539: The Effect of Functional Inspiratory Muscle Training Versus Inspiratory Muscle Training
Official title: The Effect of Functional Inspiratory Muscle Training Versus Inspiratory Muscle Training on Trunk Control and Respiratory Functions in Patients With Chronic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Muscles
Stroke
Keywords: Inspiratory Muscles Training
Exercise
Chronic Stroke
Neurodevelopmental Treatment
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 44
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

Must have been diagnosed with unilateral cerebral lesions Must be able to have been diagnosed with a stroke at least 6 months ago Must be able to the mini-mental test result is more than 24 points Having a score of 3 or above on the functional ambulation scale Must be able to follow instructions and participate in work procedures Must be able to give informed consent and volunteering

Exclusion Criteria:

Neurological disease and transient ischemic attack Multiple strokes Signs of increased intracranial pressure Uncontrolled hypertension (blood pressure higher than 150/90 on three or more occasions in the last 24 hours) Gastrocnemius muscle severely spasticity Myocardial infarction, angina, or acute heart failure in the last 3 months Uncontrollable chronic disease

Primary outcomes:
measure: Measurement of respiratory muscle strength
timeFrame: Ten week
measure: Trunk Impairment Scale
timeFrame: Ten week
measure: Trunk Control Test
timeFrame: Ten week
measure: Measurement of respiratory muscle endurance
timeFrame: Ten week
Secondary outcomes:
measure: PRONE test
timeFrame: Ten week
measure: Pulmonary function test
timeFrame: Ten week
measure: Berg Balance Scale (BDS)
timeFrame: Ten week
measure: Six Minute Walk Test (6MWT)
timeFrame: Ten week
measure: Barthel Index for Activities of Daily Living (ADL)
timeFrame: Ten week
measure: Evaluation of treatment satisfaction
timeFrame: One week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yunus Emre TÜTÜNEKEN
state: Zeytinburnu
Study officials:
References: