Respiratory Muscle Training in Patients With Subacute Ischemic Stroke

NCT06210516 | Completed

• 1 other identifier: UniversityofHealthSciences
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Subacute Stroke; Inspiratory Muscle Training

Keywords

Subacute Stroke; Ischemic; Respiratory Muscle Training; Ultrasonography; Activity Performance

Outcome Measures

Primary Outcomes (1)

• Maximal Inspiratory Pressure (MIP)

  Maximal inspiratory pressure (MIP) is the most commonly used measure to evaluate inspiratory muscle strength. Measurement of MIP is a straightforward test in which individuals are asked to perform a forceful inspiration against an occluded mouthpiece. The advantages of this test are that it is noninvasive and performed quickly.

  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 (7)

• Chest circumference measurements

  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.

• Diaphragm movements and thickness (ultrasound)

  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.

• Hand grip strength

  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.

• Motor Activity Log (MAL)

  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.

• 6 Minute Walk Test (6MWT)

  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.

Study Arms (2)

Experimental Group

ACTIVE COMPARATOR

Inspiratory muscle training, aerobic training, breathing exercises neurophysiologic rehabilitation will be applied to the experimental group. This treatment program will be applied 5 sessions a week and totally 30 sessions (6 weeks). * Inspiratory muscle training * Aerobic training * Breathing Exercises * Neurophysiological Exercise Program

Device: PowerBreathe; Other: Conventional Physiotherapy

Control Group

ACTIVE COMPARATOR

The control group will receive aerobic training, breathing exercises and neurophysiological rehabilitation, excluding inspiratory muscle training. This treatment program will be applied 5 sessions a week and totally 30 sessions (6 weeks).

Other: Conventional Physiotherapy

Interventions

PowerBreathe DEVICE

Primary Outcome Measurement: 1\. Maximal Inspiratory Pressure (MIP) Secondary Outcome Measurements: 1. Chest circumference measurements 2. Diaphragm movements and thickness (ultrasound) 3. Hand grip strength (with a Jamar hand dynamometer) 4. Motor Activity Log 5. 6 Minute Walk Test (6MWT) 6. Canadian Occupational Performance Measure 7. Charlson Comorbidity Index

Experimental Group

Conventional Physiotherapy OTHER

Primary Outcome Measurement: 1\. Maximal Inspiratory Pressure (MIP) Secondary Outcome Measurements: 1. Chest circumference measurements 2. Diaphragm movements and thickness (ultrasound) 3. Hand grip strength (with a Jamar hand dynamometer) 4. Motor Activity Log 5. 6 Minute Walk Test (6MWT) 6. Canadian Occupational Performance Measure 7. Charlson Comorbidity Index

Control Group; Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Saglik Bilimleri University

Istanbul, Europe, 34668, Turkey (Türkiye)

Location

Related Publications (1)

• Akcay S, Akyol DK, Erkut U, Karagozoglu Coskunsu D, Kunduracilar Z, Bajrami A, Dinc Yavas A. Effect Of Inspiratory Muscle Training on Diaphragm Function and Activity Performance in Subacute Ischemic Stroke Patients: A Single-Blind Randomized-Controlled Trial. Neurorehabil Neural Repair. 2026 Jan 27:15459683251412282. doi: 10.1177/15459683251412282. Online ahead of print.

  PMID: 41589338 DERIVED

MeSH Terms

Conditions

Ischemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Arsida Bajrami, M.D.

  IAU Medical Park Florya Hospital

  STUDY CHAIR

• Zuhal Kunduracılar, Prof. Dr.

  Saglik Bilimleri University

  STUDY CHAIR

• Dilber Karagözoğlu Coşkunsu, Ass.Prof.

  Fenerbahce University

  STUDY CHAIR

• Sümeyye Akçay, PT

  Saglik Bilimleri University

  PRINCIPAL INVESTIGATOR

• Dudu Kübra Akyol, PT

  IAU Medical Park Florya Hospital

  STUDY CHAIR

• Arzu Dinç Yavaş, M.D.

  IAU Medical Park Florya Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A Randomised-controlled Trial

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 18, 2024
• Study Start: April 20, 2024
• Primary Completion: September 17, 2024
• Study Completion: October 17, 2024
• Last Updated: October 21, 2024

Record last verified: 2024-10

Locations

TU (1)