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NCT Number: NCT05767372

Effect of Coherent Breathing on Elderly Quality of Life

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.

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Key information

Conditions

Stable Diabetes Mellitus Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Geriatrics Glucose Metabolism Disorders Hypertension Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

60 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of physical therapy outpatient clinic

Cairo, Giza Governorate, 12613, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Coherent Breathing Exercise

Other

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 training

Device

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.

Primary outcomes

  1. 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

  2. The five Times Sit to Stand Test

    Time frame: 12 weeks

    Evaluating fall risk

  3. The muscle quality index (MQI)

    Time frame: 12 weeks

    Evaluating age-related alterations in muscle function

  4. 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.

  5. The 6 minutes' walk test (6MWT)

    Time frame: 12 weeks

    Evaluating aerobic fitness

  6. 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.

  7. Evaluation of oxygen saturation (SPO2) and heart rate (HR)

    Time frame: 12 weeks

    By using the pulse oximeter.

Secondary outcomes

  1. 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

  2. Evaluation of forced expiratory volume at one second (FEV1) and maximum voluntary ventilation (MVV)

    Time frame: 12 weeks

    By using spirometry

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Coherent Breathing on Different Outcome Measures in Elderly

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 14, 2023
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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