Breather Exerciser Trainer on Diaphragmatic Mobility And Thickness

NCT ID: NCT06308458

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-30
• Study Completion Date: 2024-03-01

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.

Conditions

Aging Well

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Study Group (A)

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.

Group Type: EXPERIMENTAL

Breather Exerciser Trainer

Intervention Type: 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

Intervention Type: 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)

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

Group Type: OTHER

Conventional Breathing Exercise

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Adly A Adam

OTHER

Sponsor Role: lead

Responsible Party

Adly A Adam

Lecturer of Physical Therapy

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nesreen G El Nahas, PHD

Role: STUDY_CHAIR

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

Samir A El Gazar, PHD

Role: STUDY_DIRECTOR

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

Donia M El-Masry, MSc

Role: PRINCIPAL_INVESTIGATOR

Lecturer of Physical Therapy for Cardiovascular, Respiratory disorders and Geriatric

Locations

Faculty of Physical Therapy

Giza, , Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/003966

Identifier Type: -

Identifier Source: org_study_id