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Completed

NCT Number: NCT06308458

Breather Exerciser Trainer on Diaphragmatic Mobility And Thickness

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

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Key information

Conditions

Aging Well

Age range

65 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy

Giza, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. Diaphragmatic thickness in millimeters

    Time frame: Pretreatment and post treatment of 8 weeks of study protocol

    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.

  2. Diaphragmatic mobility in centimeters

    Time frame: pretreatment and post treatment of 8 weeks of study protocol

    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.

Secondary outcomes

  1. Functional Capacity

    Time frame: pretreatment and post treatment of 8 weeks of study protocol

    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.

  2. Geriatric Quality of life Questionnaire

    Time frame: pretreatment and post treatment of 8 weeks of study protocol

    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.

  3. Geriatric Quality of Life

    Time frame: pretreatment and post treatment of 8 weeks of study protocol

    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.

Sponsors and collaborators

Lead sponsor

Adly A Adam

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 13, 2024
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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