Clinical trial NCT06308458: Breather Exerciser Trainer on Diaphragmatic Mobility And Thickness
Official title: Effect Of The Breather Exerciser Trainer On Diaphragmatic Mobility And Thickness In Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging Well
Keywords: Breather Exerciser Trainer
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective pre/ posttreatment, randomized controlled study
Primary purpose: TREATMENT

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

Detailed description: Egypt is the most populous country in Middle East, with expected elder population will reach 20.8% in 2050. Almost, old population undergo sarcopenia, and dynapenia including respiratory musculatures that may associated with elevated mortality rate. Such physiological deteriorations have a potential impact on the elders quality of life.

Therefore, regular specific breathing and exercise training may promote healthier life, and permits more mechanical efficient breathing pattern, thus older population could live a hassle-free life. older adults can maintain and improve their lung capacity.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Diaphragmatic thickness in millimeters
timeFrame: Pretreatment and post treatment of 8 weeks of study protocol
measure: Diaphragmatic mobility in centimeters
timeFrame: pretreatment and post treatment of 8 weeks of study protocol
Secondary outcomes:
measure: Functional Capacity
timeFrame: pretreatment and post treatment of 8 weeks of study protocol
measure: Geriatric Quality of life Questionnaire
timeFrame: pretreatment and post treatment of 8 weeks of study protocol
measure: Geriatric Quality of Life
timeFrame: pretreatment and post treatment of 8 weeks of study protocol
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
affiliation: Head of department and Professor of Cardiovascular, Respiratory disorders, Geriatric Department
name: Nesreen G El Nahas, PHD
role: STUDY_CHAIR
affiliation: Head of department and Professor of Cardiovascular, Respiratory disorders, Geriatric Department
name: Samir A El Gazar, PHD
role: STUDY_DIRECTOR
affiliation: Lecturer of Physical Therapy for Cardiovascular, Respiratory disorders and Geriatric
name: Donia M El-Masry, MSc
role: PRINCIPAL_INVESTIGATOR
References: