Breather Exerciser Trainer on Diaphragmatic Mobility And Thickness

Aging Well Clinical Trial

Official title:

Effect Of The Breather Exerciser Trainer On Diaphragmatic Mobility And Thickness In Elderly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06308458
• Other study ID #: P.T.REC/012/003966
• Status: Completed
• Phase: N/A
• Start date: March 30, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: March 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aging Well

Intervention

Other:
• 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
• Conventional Breathing Exercise
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

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Adly A Adam

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Functional Capacity	Will use Six-Minute Walk Test, as a self-paced submaximal field exercise test to determine functional capacity according to standard procedures administrated in a 30 meters hallway.	pretreatment and post treatment of 8 weeks of study protocol
Secondary	Geriatric Quality of life Questionnaire	Will use Quality of Life Questionnaire to assess functional disability and evaluate quality of life through a comprehensive geriatric 15-dimensional standardized, self-administrated measure for health-related quality of life questionnaire. The single index score (item of 15 dimensions) on a 1-5scale, representing the overall quality of life, is calculated from the health state descriptive system by using a set of population-based preference or utility weights.; Best quality of life score is 15 'best quality of life- it is the lowest score could gained' that means sum all included items score of 1 referring to best quality of life for each dimension of the questionnaire.; While worst sum value is 75 'worst- highest score could gained, as in complete bedridden' that refers to each subitem score was 5.	pretreatment and post treatment of 8 weeks of study protocol
Secondary	Geriatric Quality of Life	Will use Katz Questionnaire as a suitable tool for assessing functional status and capability to perform activities of daily living independently.; Where 0 is the lowest score refers to complete dependent person. While 6 is the highest score refers to independent person.	pretreatment and post treatment of 8 weeks of study protocol