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临床试验/NCT06308458
NCT06308458已完成不适用

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

Adly A Adam1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年3月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Diaphragmatic mobility in centimeters

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Double masking (Investigator, Outcomes assessor

入排标准

年龄范围
65 Years 至 75 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Breather Exerciser Trainer (Other)

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.

干预措施: Conventional Breathing Exercise (Other)

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

干预措施: Conventional Breathing Exercise (Other)

结局指标

主要结局

Diaphragmatic mobility in centimeters

时间窗: 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.

Diaphragmatic thickness in millimeters

时间窗: 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.

次要结局

  • 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)
  • Functional Capacity(pretreatment and post treatment of 8 weeks of study protocol)

研究者

发起方
Adly A Adam
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Adly A Adam

Lecturer of Physical Therapy

Cairo University

研究点 (1)

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