Inspiratory Muscle Training and Expiratory Muscle Thickness

Exploring The Impact Of Inspiratory Muscle Training on Expiratory Muscle Thickness During Intensive Care Patients

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.

Study Overview

• Status: Completed
• Conditions: Muscle Weakness; Rehabilitation; Intensive Care Unit Syndrome
• Intervention / Treatment: Other: conventional physiotherapy+ IMT; Other: conventional physiotherapy

Detailed Description

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. In this single-blind randomized controlled study, 20 patients were divided into two groups: IMT and conventional physiotherapy(CP). In order to establish normative data for abdominal muscle thickness, ten healthy controls were included in the study. The CP group received CP and the IMT group received CP+IMT for five days following extubation. The thicknesses of the external oblique abdominal(EOA),internal oblique sbdominal(IOA), transversus abdominus (TRA) and rectus abdominis (RA) muscleswere evaluated The maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) were recorded.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Şişli
    • Istanbul, Şişli, Turkey
      • Istanbul Demiroglu University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• For Patients Group Inclusion Criteria:

  • 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.

Exclusion Criteria:

• For Patients Group Exclusion Criteria:

  • 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

For Healthy Group Inclusion Criteria:

• With the control and intervention group, age, characteristics and characteristics,
• Chronic system and no ongoing treatment,
• Body mass index not 40 kg/m2,
• 18-80 years old

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 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; 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; 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.
No Intervention: Healthy controls; There is no intervention in this group. Baseline measurements are to compare with experimental groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal inspiratory and expiratory pressure	Intraoral pressures measured at maximal respiration against a valve that closes the airway during maximal inspiration pressure and expiration. Maximal inspiration pressure is the highest pressure created to open closed alveoli at the residual volume level. In our study, respiratory muscle strength will be performed using a portable, electronic mouth pressure measuring with device. For the test, the applied person is given maximum expiration and at the end of this, the airway is closed with a valve and the person is asked to make maximum inspiration and continue it for 1-3 seconds. In the maximal expiration pressure measurement, after maximal inspiration, the person is asked to make a maximal expiration for 1-3 seconds against the closed airway. The best of the three measurements is selected. There should be no more than 10% or more than 10 cmH2O difference between the two best measured	Change from baseline Maximal inspiratory and expiratory pressure at 5th day]

Collaborators and Investigators

• Sponsor: Istanbul Demiroglu Bilim University
• Investigators: Study Chair: barış yılmaz, MD, Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: February 1, 2024
• First Posted (Actual): February 9, 2024

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 10, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness
• Other Study ID Numbers: IMT on abdominal muscle

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No