Clinical trial NCT06210516: Respiratory Muscle Training in Patients With Subacute Ischemic Stroke
Official title: Effect of Respiratory Muscle Training on Diaphragm Function and Activity Performance in Subacute Ischemic Stroke Patients: A Single-blind Randomised-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subacute Stroke
Inspiratory Muscle Training
Keywords: Subacute Stroke
Ischemic
Respiratory Muscle Training
Ultrasonography
Activity Performance
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomised-controlled Trial
Primary purpose: TREATMENT

Brief summary: Stroke, which can occur due to many different reasons and is one of the most common neurological conditions, is one of the leading causes of disability worldwide. The most common disorders that occur after stroke are motor disorders. In addition, these patients may be accompanied by respiratory problems such as changes in breathing patterns and decreased ventilation function. Respiratory problems are an important risk factor for the development of long-term mortality for both cardiovascular diseases and stroke. With all these changes, there is a serious decrease in the activity performance of the patients. While stroke rehabilitation focuses on motor function losses, problems in pulmonary functions do not receive the necessary attention. Evaluating and treating patients from every aspect in stroke rehabilitation will further increase the effectiveness of the treatments applied.

Ultrasonography (USG), which has been used in the field of healthcare for more than 40 years, works with a mechanism based on the principle of sound waves traveling and reflecting at different speeds in tissues of different densities. USG is a very useful and effective imaging method used by modern medicine as a part of examination and patient care, based on its advantages such as sound waves being harmless to living beings because they are non-ionizing, the image being real-time and being viewable at the time of the procedure, being a non-invasive method, and being inexpensive. This study will be included in the literature as an original study in terms of examining both the development of the patients and the effectiveness of the treatment in many aspects, with many parameters obtained by ultrasonography in subacute stroke patients who will receive respiratory muscle training.

Detailed description: According to WHO, stroke, also known as cerebrovascular accident, is a neurological condition that results in rapidly developing loss of brain function as a result of a problem in the blood supply to the brain. Stroke, which ranks third among the causes of death, is one of the leading causes of disability. This neurological condition affects not only the periphery but also the respiratory muscles such as the diaphragm and intercostal muscles, causing respiratory weakness, changes in breathing patterns, and a decrease in respiratory volume. These changes in breathing lead to a decrease in physical activity and therefore limitation in daily living activities. The decrease in respiratory muscle strength results in an increase in morbidity and mortality due to decreased pulmonary function.

Pulmonary rehabilitation (PR) is the most common non-pharmacological treatment method for pulmonary diseases. PR has been studied extensively in patients with neuromuscular disease or spinal cord injury patients with restrictive pulmonary disease; However, studies in stroke patients with respiratory complications such as pneumonia are limited.

There are studies in the literature showing that respiratory muscle training applied after stroke has positive effects on various respiratory parameters.

In this study, the development of the pulmonary muscles with respiratory muscle training after stroke will be followed by ultrasound and functional tests, and the effect of this development on hand grip strength and activity performance, which is an indicator of general muscle strength, will be examined.

Eligibility criteria: Inclusion Criteria:

* Having had a stroke for the first time,
* Being 18 years or older,
* Having an ischemic type stroke,
* At least 1 month has passed since the stroke,
* Modified Rankin Score ≥ 3,
* Ability to communicate,
* Agreeing to participate in the study.

Exclusion Criteria:

* Hemispatial neglect,
* Having a psychiatric disease,
* Having any breathing problems before the stroke,
* Not having any orthopedic, neurological or cardiopulmonary disease that would constitute a contraindication for the protocols to be applied,
* Being diagnosed with sarcopenia

Primary outcomes:
measure: Maximal Inspiratory Pressure (MIP)
timeFrame: Change from pre-interventional MIP score at the end of the 30 sessions intervention that will be performed 5 days in a week at a total of 6 weeks.
Secondary outcomes:
measure: Chest circumference measurements
timeFrame: Change from pre-interventional Chest circumference measurements at the end of the 30 sessions intervention that will be performed 5 days in a week at a total of 6 weeks.
measure: Diaphragm movements and thickness (ultrasound)
timeFrame: Change from pre-interventional diaphragm movements and thickness (ultrasound) at the end of the 30 sessions intervention that will be performed 5 days in a week at a total of 6 weeks.
measure: Hand grip strength
timeFrame: Change from pre-interventional hand grip strength at the end of the 30 sessions intervention that will be performed 5 days in a week at a total of 6 weeks.
measure: Motor Activity Log (MAL)
timeFrame: Change from pre-interventional MAL at the end of the 30 sessions intervention that will be performed 5 days in a week at a total of 6 weeks.
measure: 6 Minute Walk Test (6MWT)
timeFrame: Change from pre-interventional 6MWT at the end of the 30 sessions intervention that will be performed 5 days in a week at a total of 6 weeks.
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Change from pre-interventional COPM at the end of the 30 sessions intervention that will be performed 5 days in a week at a total of 6 weeks.
measure: Charlson Comorbidity Index
timeFrame: Change from pre-interventional Charlson Comorbidity Index score at the end of the 30 sessions intervention that will be performed 5 days in a week at a total of 6 weeks.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Saglik Bilimleri University
state: Europe
Study officials:
affiliation: IAU Medical Park Florya Hospital
name: Arsida Bajrami, M.D.
role: STUDY_CHAIR
affiliation: Saglik Bilimleri University
name: Zuhal Kunduracılar, Prof. Dr.
role: STUDY_CHAIR
affiliation: Fenerbahce University
name: Dilber Karagözoğlu Coşkunsu, Ass.Prof.
role: STUDY_CHAIR
affiliation: Saglik Bilimleri University
name: Sümeyye Akçay, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: IAU Medical Park Florya Hospital
name: Dudu Kübra Akyol, PT
role: STUDY_CHAIR
affiliation: IAU Medical Park Florya Hospital
name: Arzu Dinç Yavaş, M.D.
role: STUDY_CHAIR
References: