Inspiratory Muscle Training and Expiratory Muscle Thickness

NCT06251791 | Completed

• 1 other identifier: IMT on abdominal muscle
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

the specific effect of IMT on expiratory muscle strength and abdominal wall thickness during weaning remains unclear. To address this significant research gap, the primary objective of our study was to evaluate the effect of IMT after extubation on expiratory muscle strength and abdominal muscle thickness in respiratory ICU patients. On the other hand the investigators established reference values for ultrasonographic measurements in healthy control subjects as a comparative arm. To the best of our knowledge, this is the first study to examine the ultrasonographic effects of IMT on the expiratory muscle thickness after extubation. The investigators believe that our study may contribute to related literature in this context and guide future research as a pioneer with its unique value.

Conditions

Intensive Care Unit Syndrome; Muscle Weakness; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Abdominal Muscle Thickness

  Eksternal Oblique, Internal Oblique, Transverses Abdominus and rectus abdominus Ultrasonografic mesasurements

  Change from baseline Maximal inspiratory and expiratory pressure at 5th day]

Secondary Outcomes (1)

• Maximal inspiratory and expiratory pressure

  Change from baseline Maximal inspiratory and expiratory pressure at 5th day]

Study Arms (3)

Experimental

EXPERIMENTAL

Experimental: Conventional Physiotherapy In the intensive care unit and who had mechanical ventilation for more than 48 hours and who were extubated. In this group addition to conventional physiotherapy inspiratory muscle training will be performed with the threshold-loaded inspiratory muscle training device, starting at 30% of the maximum inspiratory mouth pressure value, during 5 days, in 2 sessions, 4 sets per day, 6-8 breaths in each set and 2 minutes of rest between sets.

Other: conventional physiotherapy+ IMT

Conventional

EXPERIMENTAL

In this group will apply only conventional physiotherapy. Conventional physiotherapy to contain breathing and,thoracal expansion exercises, bronchial hygiene techniques and gradual mobilization. Conventional physiotherapy apply for 5 days after extubation period 1 time a day.

Other: conventional physiotherapy

Healthy controls

NO INTERVENTION

There is no intervention in this group. Baseline measurements are to compare with experimental groups.

Interventions

conventional physiotherapy+ IMT OTHER

Conventional Physiotherapy to contain breathing and thoracal expansion exercises, bronchial hygiene techniques and gradual mobilization in 1 time a day. Conventional Physiotherapy to contain breathing and thoracal expansion exercises, bronchial hygiene techniques and gradual mobilization in 1 time a day. In this group addition to conventional physiotherapy inspiratory muscle training will be performed with the threshold-loaded inspiratory muscle training device, starting at 30% of the maximum inspiratory mouth pressure value, during 5 days, in 2 sessions, 4 sets per day, 6-8 breaths in each set and 2 minutes of rest between sets.

Experimental

conventional physiotherapy OTHER

Conventional Physiotherapy to contain breathing and thoracal expansion exercises, bronchial hygiene techniques and gradual mobilization in 1 time a day. Conventional Physiotherapy to contain breathing and thoracal expansion exercises, bronchial hygiene techniques and gradual mobilization in 1 time a day.

Conventional

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Needing mechanical ventilation support longer than 2 days,
• Alert and Riker Sedation Agitation Score \>4
• Being hemodynamically stable (HR\<140 beats/min, BP stable)
• Dobutamine and minimal vasopressor use
• Fever of 36.5-38.5
• Body Mass Index \<40 m2/cm,
• FiO2 of 0.5 or less,
• Absence of myocardial ischemia.

You may not qualify if:

• Noncooperation
• Phrenic nerve damage
• Chest wall trauma and/or deformity to prevent diaphragmatic movement
• Progressive neuromuscular disease with respiratory involvement
• There is enough secretion to require more than one aspiration every hour.
• Patients using sedative drugs continuously
• High-dose cortisol use
• Using a home mechanical ventilator before mechanical ventilation in intensive care unit
• With the control and intervention group, age, characteristics and characteristics,
• Chronic system and no ongoing treatment,
• Body mass index not 40 kg/m2,
• years old

Sponsors & Collaborators

• Istanbul Demiroglu Bilim University: lead

Study Sites (1)

Istanbul Demiroglu University

Istanbul, Şişli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• barış yılmaz, MD

  Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel Assignment Parallel Assignment Randomized Healthy participants

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 9, 2024
• Study Start: September 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: November 1, 2023
• Last Updated: February 13, 2024

Record last verified: 2024-02

Locations

TU (1)