Effect of Coherent Breathing on Elderly Quality of Life

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05767372

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

29.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Stable Diabetes Mellitus Geriatrics Hypertension	Other: Coherent Breathing Exercise Device: Inspiratory muscle training	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Effect of Coherent Breathing on Different Outcome Measures in Elderly

Actual Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study group The participants will receive Inspiratory muscle trainer and Coherent breathing exercise three times per week for 12 weeks.	Other: Coherent Breathing Exercise 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. Device: Inspiratory muscle training 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.
Experimental: Control group The participants will receive Inspiratory muscle training three times per week for 12 weeks.	Device: Inspiratory muscle training 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.

Arm

Intervention/Treatment

Experimental: Study group

The participants will receive Inspiratory muscle trainer and Coherent breathing exercise three times per week for 12 weeks.

Other: Coherent Breathing Exercise

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.

Device: Inspiratory muscle training

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.

Experimental: Control group

The participants will receive Inspiratory muscle training three times per week for 12 weeks.

Device: Inspiratory muscle training

Outcome Measures

Primary Outcome Measures

Tinetti Performance Oriented Mobility Assessment (POMA) [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 [12 weeks]
Evaluating fall risk
The muscle quality index (MQI) [12 weeks]
Evaluating age-related alterations in muscle function
The Geriatric Depression Scale (GDS) [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) [12 weeks]
Evaluating aerobic fitness
Short form Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) [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) [12 weeks]
By using the pulse oximeter.

Secondary Outcome Measures

Modified Borg Dyspnoea Scale [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
Evaluation of forced expiratory volume at one second (FEV1) and maximum voluntary ventilation (MVV) [12 weeks]
By using spirometry

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of physical therapy outpatient clinic	Cairo	Giza	Egypt	12613

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: Sherif O Elabd, Master, May University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rana Elbanna, lecturer at faculty of physical therapy at Cairo University, Cairo University

ClinicalTrials.gov Identifier:

NCT05767372

Other Study ID Numbers:

Dr Sherif Elabd

First Posted:

Mar 14, 2023

Last Update Posted:

Mar 14, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Mar 14, 2023