Aging WellNCT06308458
Breather Exerciser Trainer on Diaphragmatic Mobility And Thickness
A study testing Breather Exerciser Trainer and Conventional Breathing Exercise in people with Aging Well, run by Adly A Adam at 1 site in Egypt.
Trial summary
The purpose of this study is to the effect of the breather exerciser trainer on diaphragmatic mobility and thickness in elderly. Read more about this study
- Who is it for?
- Ages 65 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging Well
- What is being tested?
- Breather Exerciser Trainer and Conventional Breathing Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Mar 2023to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 75 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect Of The Breather Exerciser Trainer On Diaphragmatic Mobility And Thickness In Elderly
The purpose of this study is to the effect of the breather exerciser trainer on diaphragmatic mobility and thickness in elderly.
Read the 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
- Being tested
- Breather Exerciser Trainer, Conventional Breathing Exercise
- Keywords
- Breather Exerciser Trainer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breather Exerciser TrainerOther
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 ExerciseOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Breather Exerciser Trainer; Other: Conventional Breathing Exercise |
| 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 Receives: Other: Conventional Breathing Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pretreatment and post treatment of 8 weeks of study protocol
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.
Measured: pretreatment and post treatment of 8 weeks of study protocol
Secondary outcomes (3)
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.
Measured: pretreatment and post treatment of 8 weeks of study protocol
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.
Measured: pretreatment and post treatment of 8 weeks of study protocol
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.
Measured: pretreatment and post treatment of 8 weeks of study protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start30 Mar 2023
- Primary completion1 Jan 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aging WellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective pre/ posttreatment, randomized controlled study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adly A Adam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Adly A Adam, Cairo University
- Investigators
- Nesreen G El Nahas, PHD, Study chair, Head of department and Professor of Cardiovascular, Respiratory disorders, Geriatric DepartmentSamir A El Gazar, PHD, Study director, Head of department and Professor of Cardiovascular, Respiratory disorders, Geriatric DepartmentDonia M El-Masry, MSc, Principal investigator, Lecturer of Physical Therapy for Cardiovascular, Respiratory disorders and Geriatric
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308458
- Sponsor's protocol ID
- P.T.REC/012/003966
- Status last verified
- Mar 2024
- First submitted
- 23 Feb 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study purpose, Selection, and randomization, detailed intervention procedures, and statistical analysis, plus revealed results and conclusion
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of The Breather Exerciser Trainer On Diaphragmatic Mobility And Thickness In Elderly
- ClinicalTrials.gov ID
- NCT06308458
- Acronym / sponsor ID
- P.T.REC/012/003966
- Conditions
- Aging Well
- Keywords
- Breather Exerciser Trainer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Adly A AdamUniversity, hospital or other
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 13 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective pre/ posttreatment, randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Study Group (A) | Experimental | Other: Breather Exerciser Trainer, Other: Conventional Breathing ExerciseExperimental (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. |
| Control Group (B) | Other | Other: Conventional Breathing ExerciseControl (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 |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breather Exerciser TrainerGradual 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 | Other | Study Group (A) |
| Conventional Breathing ExerciseDiaphragmatic 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 | Other | Control Group (B), Study Group (A) |
Primary outcome
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.
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.
3 secondary outcomes
Functional Capacity
Time frame: pretreatment and post treatment of 8 weeks of study protocol
Geriatric Quality of life Questionnaire
Time frame: pretreatment and post treatment of 8 weeks of study protocol
Geriatric Quality of Life
Time frame: pretreatment and post treatment of 8 weeks of study protocol
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: Yes. Study purpose, Selection, and randomization, detailed intervention procedures, and statistical analysis, plus revealed results and conclusion
Related trials for Aging Well
Active, not recruiting
Emotional Well-being and Measures of Healthy Aging
Aging, Aging, Healthy
Recruiting
Polypharmacy on Healthy Aging in People Living With HIV Over the Age of 75
Virus-HIV
Active, not recruitingObservational study
Healthy Aging in Neighborhoods of Diversity Across the Life Span (HANDLS)
Diabetes, Cerebrovascular Disease
Not yet recruiting
Effects of Increased Water Intake on Hormonal Response, Hydration Status, and Physical Function in Low-drinking Older Adults
Dehydrated, Water-Electrolyte Imbalance, Malnutrition, Dehydration (Physiology)
Not yet recruitingObservational study
China Healthy Aging and Fitness Longitudinal Study
Physical Fitness, Aging
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nesreen G El Nahas, PHD study chair
Head of department and Professor of Cardiovascular, Respiratory disorders, Geriatric Department
Samir A El Gazar, PHD study director
Head of department and Professor of Cardiovascular, Respiratory disorders, Geriatric Department
Donia M El-Masry, MSc principal investigator
Lecturer of Physical Therapy for Cardiovascular, Respiratory disorders and Geriatric
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breather Exerciser Trainer and Conventional Breathing Exercise in people with Aging Well, run by Adly A Adam at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragmatic thickness in millimeters (time frame: Pretreatment and post treatment of 8 weeks of study protocol). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.