The Effect of Inspiratory Exercises on Diaphragm and Intercostal Muscle Thickness in Stroke Patients

NCT07206641 | Not Yet Recruiting

• 1 other identifier: MarmaraU-FTR-OK-1
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the effect of inspiratory muscle strengthening exercises on bilateral parasternal intercostal muscle thickness and bilateral diaphragm muscle thickness in stroke patients and to present new data on whether the possible effect on the affected side can be associated with changes in respiratory parameters. Furthermore, as previous literature has shown that 4-week exercise programs are more effective than \>6-week exercise programs, an interim assessment is planned for the second week of treatment in this study to evaluate shorter-term changes. Four weeks after completion of the exercise program (in the 8th week), patients will be re-evaluated to track potential short-term effects.

Conditions

Stroke

Keywords

Stroke; IMT; Inspiratory Muscle Training; Diapragm Thickness; Intercostal muscle thickness

Outcome Measures

Primary Outcomes (2)

• Diaphragm muscle thickness

  In this study, ultrasonography will be used to examine the structure and function of the muscle and to measure muscle thickness at the end of inspiration and expiration.

  Will be performed using an ultrasound device before treatment, at the 2nd week of treatment, at the end of treatment (4th week), and 4 weeks after the completion of treatment (8th week).

• Intercostal muscle thickness

  In this study, ultrasonography will be used to examine the structure and function of the muscle and to measure muscle thickness at the end of inspiration and expiration.

  Will be performed using an ultrasound device before treatment, at the 2nd week of treatment, at the end of treatment (4th week), and 4 weeks after the completion of treatment (8th week).

Secondary Outcomes (6)

• Berg Balance Scale

  Will be evaluated before treatment, at the 2nd week of treatment, at the end of treatment (4th week), and 4 weeks after the completion of treatment (8th week).

• Tinetti Test

  Will be evaluated before treatment, at the 2nd week of treatment, at the end of treatment (4th week), and 4 weeks after the completion of treatment (8th week).

• Stroke-Specific Quality of Life Scale

  Will be evaluated before treatment, at the 2nd week of treatment, at the end of treatment (4th week), and 4 weeks after the completion of treatment (8th week).

• Forced Vital Capacity

  Will be measured using spirometry before treatment, at the end of treatment (4th week), and 4 weeks after the completion of treatment (8th week)

• Forced Expiratory Volume

  Will be measured using spirometry before treatment, at the end of treatment (4th week), and 4 weeks after the completion of treatment (8th week).

Study Arms (1)

GROUP 1: Patients diagnosed with stroke who will be followed with inspiratory strengthening exercise

Eligibility Criteria

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

Study Population

Patients aged 18-65 years diagnosed with stroke Sample Size of the Study: 35 Stroke patients

You may qualify if:

• Patients with a history of ischemic or hemorrhagic stroke
• Aged 18-65 years

You may not qualify if:

• Presence of concomitant acute or chronic lung disease
• History of thoracic or abdominal surgery
• Presence of another neuromuscular disease
• Patients with aphasia or impaired cognition
• Severe heart disease
• Active cancer
• Mini-Mental State Examination (MMSE) score ≤ 24
• Active smoking

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara Üniversitesi Tıp Fakültesi, Istanbul, Maltepe 34854

Istanbul, Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Oguzhan Kasimoglu

CONTACT

+90 5448911835; kasimogluoguzhan@gmail.com

Ozge Kenis Coskun

CONTACT

ozgekenis@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: October 3, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)