Breather Exerciser Trainer on Diaphragmatic Mobility And Thickness

NCT06308458 | Completed DMC

• 1 other identifier: P.T.REC/012/003966
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to the effect of the breather exerciser trainer on diaphragmatic mobility and thickness in elderly.

Conditions

Aging Well

Keywords

Breather Exerciser Trainer

Outcome Measures

Primary Outcomes (2)

• Diaphragmatic thickness in millimeters

  Preirus ultrasound device (Hitachi Medical Systems, Tokyo, Japan), with A 6-13 MHz linear probe will be utilized for diaphragm thickness assessment. Diaphragm thickness will be measured from the 8th or 9th intercostal space. Diaphragm thickness will measure thickness on expiration and during deep breathing to assess percentage of thickening during inspiration. and diaphragm thickness will expressed in millimeters.

  Pretreatment and post treatment of 8 weeks of study protocol

• Diaphragmatic mobility in centimeters

  Preirus ultrasound device (Hitachi Medical Systems, Tokyo, Japan). a 1-5 MHz convex probe will be used for diaphragm mobility assessment. Diaphragm mobility will be measured from the costal line junction of the medial axillary line. The excursions of two hemidiaphragms will be measured using two-dimensional or M-mode ultrasonography, during respiratory maneuvers. Diaphragmatic mobility will be expressed in centimeters.

  pretreatment and post treatment of 8 weeks of study protocol

Secondary Outcomes (3)

• Functional Capacity

  pretreatment and post treatment of 8 weeks of study protocol

• Geriatric Quality of life Questionnaire

  pretreatment and post treatment of 8 weeks of study protocol

• Geriatric Quality of Life

  pretreatment and post treatment of 8 weeks of study protocol

Study Arms (2)

Study Group (A)

EXPERIMENTAL

Experimental (Breather Exerciser Trainer + conventional breathing exercises) Group 30 healthy elders will receive inspiratory muscle training by breather exerciser trainer (Gradual intensity from 2-3 rate of perceived exertion (RPE) up to reach 5-7 RPE, with gradual frequency; 1st week 8 sets of 5 repetitions '1 minute rest', 2nd week be 9 sets, and 3rd week reach 10 sets of 5 repetitions. then from 4-8 weeks 'end of study protocol' will be 10 sets of 6 repetitions with 1 minute rest between sets.), along with conventional breathing exercises (Diaphragmatic breathing, Pursed-up breathing, and Exercise connected with respiration), for 5 sessions per week for eight weeks.

Other: Breather Exerciser Trainer; Other: Conventional Breathing Exercise

Control Group (B)

OTHER

Control (conventional breathing exercises) Group: 30 health elders will receive conventional breathing exercises (Diaphragmatic breathing; Pursed-up breathing, Exercise connected with respiration for 5 times a week for a total 8 weeks

Other: Conventional Breathing Exercise

Interventions

Breather Exerciser Trainer OTHER

Gradual intensity from 2-3 rate of perceived exertion (RPE) up to reach 5-7 RPE, with gradual frequency; 1st week 8 sets of 5 repetitions '1 minute rest', 2nd week be 9 sets, and 3rd week reach 10 sets of 5 repetitions. then from 4-8 weeks 'end of study protocol' will be 10 sets of 6 repetitions with 1 minute rest between sets.), along with conventional breathing exercises (Diaphragmatic breathing, Pursed-up breathing, and Exercise connected with respiration), for 5 sessions per week for eight weeks

Study Group (A)

Conventional Breathing Exercise OTHER

Diaphragmatic breathing; place one hand on upper chest and the other on belly. Patient Breathe in slowly through nose, letting the air in deeply towards lower belly then patient is asked to tighten abdominal muscles and let them fall inward during exhalation through pursed lips Pursed-up breathing; by inhales through nose and exhales over 4 and 6 seconds in a whistling position Exercise connected with respiration; repetitive bilateral shoulder flexion then repetitive bilateral shoulder abduction, synchronized with breathing

Control Group (B); Study Group (A)

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age range 65-75 years old of both genders
• Oriented elder subjects assessed for cognitive impairment with score greater than 30 on Mini- Mental Scale.
• Healthy elders with normal pulmonary function test values according to reference values.

You may not qualify if:

• Using any medications affect muscular strength.
• Active hemoptysis, untreated pneumothorax, recent esophageal surgeries.
• Acute or chronic pulmonary diseases, or decompensated heart failure.
• Acute upper respiratory stenosis 'true vocal fold mass, vocal fold paralysis in adducted position, sub-glottic stenosis' or recent oral, facial or skull trauma or surgeries, also acute sinusitis, epistaxis, hemodynamic instability, tympanic membrane rupture, or acute middle ear pathology 'otitis or labyrinthitis'.
• Active smokers.
• Subjects with previous neurological disorders affecting respiratory muscles or any muscular dystrophies.
• Subjects with previous cervical or thoracic surgeries.
• Presence of hemodynamic instability 'heart rate more than 150beat per minute, or systolic blood pressure more than 140 mmHg, or diastolic blood pressure more than 90 mmHg'
• Presence of severe cognitive impairments affects their understanding of any steps of study protocol.
• Uncooperative individuals during chest ultrasound measurement that require performance of deep inspiration and full expiration.

Sponsors & Collaborators

• Adly A Adam: lead

Study Sites (1)

Faculty of Physical Therapy

Giza, Egypt

Location

Study Officials

• Nesreen G El Nahas, PHD

  Head of department and Professor of Cardiovascular, Respiratory disorders, Geriatric Department

  STUDY CHAIR

• Samir A El Gazar, PHD

  Head of department and Professor of Cardiovascular, Respiratory disorders, Geriatric Department

  STUDY DIRECTOR

• Donia M El-Masry, MSc

  Lecturer of Physical Therapy for Cardiovascular, Respiratory disorders and Geriatric

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double masking (Investigator, Outcomes assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of Physical Therapy

Model Details: Prospective pre/ posttreatment, randomized controlled study

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 13, 2024
• Study Start: March 30, 2023
• Primary Completion: January 1, 2024
• Study Completion: March 1, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 3-5months
• Access Criteria: adampt80a@gmail.com

Locations

EG (1)