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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05767372
Other study ID # Dr Sherif Elabd
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2023
Est. completion date June 30, 2023

Study information

Verified date September 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 30, 2023
Est. primary completion date June 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Egypt Faculty of physical therapy outpatient clinic Cairo Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
12 weeks
Primary The five Times Sit to Stand Test Evaluating fall risk 12 weeks
Primary The muscle quality index (MQI) Evaluating age-related alterations in muscle function 12 weeks
Primary 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. 12 weeks
Primary The 6 minutes' walk test (6MWT) Evaluating aerobic fitness 12 weeks
Primary 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.
12 weeks
Primary Evaluation of oxygen saturation (SPO2) and heart rate (HR) By using the pulse oximeter. 12 weeks
Secondary 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 12 weeks
Secondary Evaluation of forced expiratory volume at one second (FEV1) and maximum voluntary ventilation (MVV) By using spirometry 12 weeks
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