Inspiratory Muscle Training and Expiratory Muscle Thickness

NCT ID: NCT06251791

Last Updated: 2024-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2023-11-01

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.

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.

Conditions

Intensive Care Unit Syndrome; Muscle Weakness; Rehabilitation

Study Design

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

Study Groups

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.

Group Type: EXPERIMENTAL

conventional physiotherapy+ IMT

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

conventional physiotherapy

Intervention Type: 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.

Healthy controls

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul Demiroglu Bilim University

OTHER

Sponsor Role: lead

Responsible Party

Reyhan Kaygusuz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

barış yılmaz, MD

Role: STUDY_CHAIR

Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital

Locations

Istanbul Demiroglu University

Istanbul, Şişli, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

IMT on abdominal muscle

Identifier Type: -

Identifier Source: org_study_id