Effect of Coherent Breathing on Elderly Quality of Life

September 11, 2023 updated by: Rana Elbanna, Cairo University

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Giza
      • Cairo, Giza, Egypt, 12613
        • Faculty of physical therapy outpatient clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Elderly subject of both gender with age ranged from 60 to 70 years old.
  2. BMI will be ranged from 25 to 29.9.
  3. Clinically and medically stable.
  4. Able to understand the requirements of the study.
  5. Conscious patient and respond to verbal command.

Exclusion Criteria:

  1. Neurological conditions (e.g., stroke history, Parkinson's disease).
  2. Presence of an acute illness.
  3. Metabolically unstable chronic illness.
  4. Pre-existent untreated metabolic or renal disease.
  5. Patient undergoes chemotherapy.
  6. Recent surgery.
  7. Uncontrolled diabetes or hypertension.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

  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.

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

  • Minimum score: 16
  • Maximum score: 80
  • High score means worse outcome.
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sherif O Elabd, Master, May University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Actual)

June 15, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

February 22, 2023

First Submitted That Met QC Criteria

March 2, 2023

First Posted (Actual)

March 14, 2023

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 11, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Dr Sherif Elabd

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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