Stable Diabetes MellitusNCT05767372
Effect of Coherent Breathing on Elderly Quality of Life
A study testing Coherent Breathing Exercise and Inspiratory muscle training in people with Stable Diabetes Mellitus and Geriatrics, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be carried out on sixty elderlies of both gender with ages ranges from 60 to 70 years old. The participants will receive Inspiratory muscle trainer and/or Coherent breathing exercise three times per week for 12 weeks. Read more about this study
- Who is it for?
- Ages 60 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Stable Diabetes Mellitus, Geriatrics, Hypertension
- What is being tested?
- Coherent Breathing Exercise and Inspiratory muscle training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 30 Jun 2023
- 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 60 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elderly subject of both gender with age ranged from 60 to 70 years old.
- BMI will be ranged from 25 to 29.9.
- Clinically and medically stable.
- Able to understand the requirements of the study.
- Conscious patient and respond to verbal command.
Who cannot join
- Neurological conditions (e.g., stroke history, Parkinson's disease).
- Presence of an acute illness.
- Metabolically unstable chronic illness.
- Pre-existent untreated metabolic or renal disease.
- Patient undergoes chemotherapy.
- Recent surgery.
- Uncontrolled diabetes or hypertension.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of physical therapy outpatient clinic
Cairo, Giza Governorate, 12613
About this study
Official title: Effect of Coherent Breathing on Different Outcome Measures in Elderly
This study will be carried out on sixty elderlies of both gender with ages ranges from 60 to 70 years old. The participants will receive Inspiratory muscle trainer and/or Coherent breathing exercise three times per week for 12 weeks.
- Conditions
- Stable Diabetes Mellitus, Geriatrics, Hypertension
- Being tested
- Coherent Breathing Exercise, Inspiratory muscle training
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coherent Breathing ExerciseOther
Step 1: Focus on your natural breathing and count the time of your inhale and exhale.
Step 2: Sit in a comfortable position to practice the coherent breathing technique. Gently place one hand on your stomach.
Step 3: Inhale for four seconds and then exhale for four seconds. Repeat this for one minute.
Step 4: Repeat the above step but lengthen your inhales and exhale for five seconds.
Step 5: Repeat the above step but extend the breaths to six seconds. Once you're able to do this for five minutes, gradually work your way up to 20 minutes.
During this breathing exercise, keep your hand on your stomach. Using diaphragmatic breathing can help you feel your breaths.
Inspiratory muscle trainingDevice
The patient was in the comfortable sitting position and then put the nose clip on the patient's nose
- After setting the maximum training; the user recognized the load at which they could effectively execute ten breaths at greatest resistance relying upon the patient's pace of apparent effort.
- Training was begun with a load at low intensity 20-30% of the patient maximum 10 repetition method using inspiratory muscle training (IMT) device.
- Progress slowly and monitor carefully.
- As the inspiratory muscle became stronger the inspiratory load was progressed to 50% of maximum effort over 3 weeks as tolerated.
- Patient took full breath in (maximal and deep inspiration) then longer and slow expiration. Continue this breathing pattern for 10-20 breath.
- Repeated step (5), 4-6 times or about 10-15minutes with rest in between 30 seconds.
- The session was repeated three times per week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Coherent breathing group | Experimental | The participants will receive Inspiratory muscle trainer and Coherent breathing exercise three times per week for 12 weeks. Receives: Other: Coherent Breathing Exercise |
| Inspiratory muscle training group | Experimental | The participants will receive Inspiratory muscle training three times per week for 12 weeks. Receives: Device: Inspiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinetti Performance Oriented Mobility Assessment (POMA)
Evaluating tests of balance and gait
Description:
The Tinetti assessment tool is an easily administered task-oriented test that measures an older adult's Scoring: A three-point ordinal scale, ranging from 0-2. "0" indicates the highest level of impairment and "2" the individuals independence. Total Balance Score = 16 Total Gait Score = 12 Total Test Score = 28 Interpretation: 25-28 = low fall risk 19-24 = medium fall risk < 19 = high fall risk
Measured: 12 weeks
The five Times Sit to Stand Test
Evaluating fall risk
Measured: 12 weeks
The muscle quality index (MQI)
Evaluating age-related alterations in muscle function
Measured: 12 weeks
The Geriatric Depression Scale (GDS)
Evaluating psychological aspect Of the 15 items, 10 indicated the presence of depression when answered positively, while the rest (question numbers 1, 5, 7, 11, 13) indicated depression when answered negatively. Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.
Measured: 12 weeks
The 6 minutes' walk test (6MWT)
Evaluating aerobic fitness
Measured: 12 weeks
Short form Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)
Evaluating cognitive decline
- Minimum score: 16
- Maximum score: 80
- High score means worse outcome.
Measured: 12 weeks
Evaluation of oxygen saturation (SPO2) and heart rate (HR)
By using the pulse oximeter.
Measured: 12 weeks
Secondary outcomes (2)
Modified Borg Dyspnoea Scale
Evaluating level of exertion during exercise It starts at number 0 where your breathing is causing you no difficulty at all and progresses through to number 10 where your breathing difficulty is maximal
Measured: 12 weeks
Evaluation of forced expiratory volume at one second (FEV1) and maximum voluntary ventilation (MVV)
By using spirometry
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start1 Mar 2023
- Primary completion15 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Elbanna, Cairo University
- Investigators
- Sherif O Elabd, Master, Principal investigator, May University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05767372
- Sponsor's protocol ID
- Dr Sherif Elabd
- Status last verified
- Sep 2023
- First submitted
- 22 Feb 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Coherent Breathing on Different Outcome Measures in Elderly
- ClinicalTrials.gov ID
- NCT05767372
- Acronym / sponsor ID
- Dr Sherif Elabd
- Conditions
- Stable Diabetes Mellitus, Geriatrics, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 14 Mar 2023 (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.
This study will be carried out on sixty elderlies of both gender with ages ranges from 60 to 70 years old. The participants will receive Inspiratory muscle trainer and/or Coherent breathing exercise three times per week for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coherent breathing group | Experimental | Other: Coherent Breathing ExerciseThe participants will receive Inspiratory muscle trainer and Coherent breathing exercise three times per week for 12 weeks. |
| Inspiratory muscle training group | Experimental | Device: Inspiratory muscle trainingThe participants will receive Inspiratory muscle training three times per week for 12 weeks. |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Elderly subject of both gender with age ranged from 60 to 70 years old.
- BMI will be ranged from 25 to 29.9.
- Clinically and medically stable.
- Able to understand the requirements of the study.
- Conscious patient and respond to verbal command.
Key exclusion criteria (7 listed)
- Neurological conditions (e.g., stroke history, Parkinson's disease).
- Presence of an acute illness.
- Metabolically unstable chronic illness.
- Pre-existent untreated metabolic or renal disease.
- Patient undergoes chemotherapy.
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 |
|---|---|---|
| Coherent Breathing ExerciseStep 1: Focus on your natural breathing and count the time of your inhale and exhale. Step 2: Sit in a comfortable position to practice the coherent breathing technique. Gently place one hand on your stomach. Step 3: Inhale for four seconds and then exhale for four seconds. Repeat this for one minute. Step 4: Repeat the above step but lengthen your inhales and exhale for five seconds. Step 5: Repeat the above step but extend the breaths to six seconds. Once you're able to do this for five minutes, gradually work your way up to 20 minutes. During this breathing exercise, keep your hand on your stomach. Using diaphragmatic breathing can help you feel your breaths. | Other | Coherent breathing group |
| Inspiratory muscle trainingThe patient was in the comfortable sitting position and then put the nose clip on the patient's nose 1. After setting the maximum training; the user recognized the load at which they could effectively execute ten breaths at greatest resistance relying upon the patient's pace of apparent effort. 2. Training was begun with a load at low intensity 20-30% of the patient maximum 10 repetition method using inspiratory muscle training (IMT) device. 3. Progress slowly and monitor carefully. 4. As the inspiratory muscle became stronger the inspiratory load was progressed to 50% of maximum effort over 3 weeks as tolerated. 5. Patient took full breath in (maximal and deep inspiration) then longer and slow expiration. Continue this breathing pattern for 10-20 breath. 6. Repeated step (5), 4-6 times or about 10-15minutes with rest in between 30 seconds. 7. The session was repeated three times per week for 12 weeks. | Device | Inspiratory muscle training group |
Primary outcome
Tinetti Performance Oriented Mobility Assessment (POMA)
Time frame: 12 weeks
Evaluating tests of balance and gait Description: The Tinetti assessment tool is an easily administered task-oriented test that measures an older adult's Scoring: A three-point ordinal scale, ranging from 0-2. "0" indicates the highest level of impairment and "2" the individuals independence. Total Balance Score = 16 Total Gait Score = 12 Total Test Score = 28 Interpretation: 25-28 = low fall risk 19-24 = medium fall risk < 19 = high fall risk
The five Times Sit to Stand Test
Time frame: 12 weeks
Evaluating fall risk
The muscle quality index (MQI)
Time frame: 12 weeks
Evaluating age-related alterations in muscle function
The Geriatric Depression Scale (GDS)
Time frame: 12 weeks
Evaluating psychological aspect Of the 15 items, 10 indicated the presence of depression when answered positively, while the rest (question numbers 1, 5, 7, 11, 13) indicated depression when answered negatively. Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.
The 6 minutes' walk test (6MWT)
Time frame: 12 weeks
Evaluating aerobic fitness
Short form Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)
Time frame: 12 weeks
Evaluating cognitive decline * Minimum score: 16 * Maximum score: 80 * High score means worse outcome.
Evaluation of oxygen saturation (SPO2) and heart rate (HR)
Time frame: 12 weeks
By using the pulse oximeter.
2 secondary outcomes
Modified Borg Dyspnoea Scale
Time frame: 12 weeks
Evaluation of forced expiratory volume at one second (FEV1) and maximum voluntary ventilation (MVV)
Time frame: 12 weeks
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 Sep 2023.
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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.
Sherif O Elabd, Master principal investigator
May University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coherent Breathing Exercise and Inspiratory muscle training in people with Stable Diabetes Mellitus and Geriatrics, run by Cairo University 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 5 inclusion and 7 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 Sep 2023. 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?
Tinetti Performance Oriented Mobility Assessment (POMA) (time frame: 12 weeks). The study lists 7 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 Sep 2023.