Respiratory Muscle Training in Patients With Subacute Ischemic Stroke

NCT ID: NCT06210516

Last Updated: 2024-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-20
• Study Completion Date: 2024-10-17

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.

Conditions

Subacute Stroke; Inspiratory Muscle Training

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental Group

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

Group Type: ACTIVE_COMPARATOR

PowerBreathe

Intervention Type: 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

Conventional Physiotherapy

Intervention Type: 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

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).

Group Type: ACTIVE_COMPARATOR

Conventional Physiotherapy

Intervention Type: 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

Interventions

PowerBreathe

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

Intervention Type: DEVICE

Conventional Physiotherapy

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saglik Bilimleri Universitesi

OTHER

Sponsor Role: lead

Responsible Party

Sümeyye Akçay

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arsida Bajrami, M.D.

Role: STUDY_CHAIR

IAU Medical Park Florya Hospital

Zuhal Kunduracılar, Prof. Dr.

Role: STUDY_CHAIR

Saglik Bilimleri University

Dilber Karagözoğlu Coşkunsu, Ass.Prof.

Role: STUDY_CHAIR

Fenerbahce University

Sümeyye Akçay, PT

Role: PRINCIPAL_INVESTIGATOR

Saglik Bilimleri University

Dudu Kübra Akyol, PT

Role: STUDY_CHAIR

IAU Medical Park Florya Hospital

Arzu Dinç Yavaş, M.D.

Role: STUDY_CHAIR

IAU Medical Park Florya Hospital

Locations

Saglik Bilimleri University

Istanbul, Europe, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

UniversityofHealthSciences

Identifier Type: -

Identifier Source: org_study_id