- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05767372
Effect of Coherent Breathing on Elderly Quality of Life
Effect of Coherent Breathing on Different Outcome Measures in Elderly
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Giza
-
Cairo, Giza, Egypt, 12613
- Faculty of physical therapy outpatient clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Coherent breathing group
The participants will receive Inspiratory muscle trainer and Coherent breathing exercise three times per week for 12 weeks.
|
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. |
|
Experimental: Inspiratory muscle training group
The participants will receive Inspiratory muscle training three times per week for 12 weeks.
|
The patient was in the comfortable sitting position and then put the nose clip on the patient's nose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 |
12 weeks
|
|
The five Times Sit to Stand Test
Time Frame: 12 weeks
|
Evaluating fall risk
|
12 weeks
|
|
The muscle quality index (MQI)
Time Frame: 12 weeks
|
Evaluating age-related alterations in muscle function
|
12 weeks
|
|
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.
|
12 weeks
|
|
The 6 minutes' walk test (6MWT)
Time Frame: 12 weeks
|
Evaluating aerobic fitness
|
12 weeks
|
|
Short form Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)
Time Frame: 12 weeks
|
Evaluating cognitive decline
|
12 weeks
|
|
Evaluation of oxygen saturation (SPO2) and heart rate (HR)
Time Frame: 12 weeks
|
By using the pulse oximeter.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Borg Dyspnoea Scale
Time Frame: 12 weeks
|
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
|
12 weeks
|
|
Evaluation of forced expiratory volume at one second (FEV1) and maximum voluntary ventilation (MVV)
Time Frame: 12 weeks
|
By using spirometry
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sherif O Elabd, Master, May University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dr Sherif Elabd
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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