NCT05767372

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 14, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

4 months

First QC Date

February 22, 2023

Last Update Submit

September 11, 2023

Conditions

Outcome Measures

Primary Outcomes (7)

  • 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

  • The five Times Sit to Stand Test

    Evaluating fall risk

    12 weeks

  • The muscle quality index (MQI)

    Evaluating age-related alterations in muscle function

    12 weeks

  • 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

  • The 6 minutes' walk test (6MWT)

    Evaluating aerobic fitness

    12 weeks

  • 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

  • Evaluation of oxygen saturation (SPO2) and heart rate (HR)

    By using the pulse oximeter.

    12 weeks

Secondary Outcomes (2)

  • Modified Borg Dyspnoea Scale

    12 weeks

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

    12 weeks

Study Arms (2)

Coherent breathing group

EXPERIMENTAL

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

Other: Coherent Breathing Exercise

Inspiratory muscle training group

EXPERIMENTAL

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

Device: Inspiratory muscle training

Interventions

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.

Coherent breathing group

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.

Inspiratory muscle training group

Eligibility Criteria

Age60 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy outpatient clinic

Cairo, Giza Governorate, 12613, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Hypertension

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Sherif O Elabd, Master

    May University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer at faculty of physical therapy at Cairo University

Study Record Dates

First Submitted

February 22, 2023

First Posted

March 14, 2023

Study Start

March 1, 2023

Primary Completion

June 15, 2023

Study Completion

June 30, 2023

Last Updated

September 13, 2023

Record last verified: 2023-09

Locations