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Geriatrics Balance Disturbance With High Risk Falling, Osteoporosis, Vestibular Age Related Changes, Female Post-menopausal Based on HistoryNCT06835413

Monitoring Combined Effect of Balance and Strengthening Exercises on Static and Dynamic Balance in Elderly Populations

A study testing 1-Balance Exercises A- Standing with a decreased base B- Graded reaching in standing C- Stepping in different directions D- Walking practice 2-Strength and Balance Exercises A- Sit-to-stand B- Heel r in people with Geriatrics Balance Disturbance With High Risk Falling, Osteoporosis, Vestibular Age Related Changes, Female Post-menopausal Based on History, run by South Valley University at 1 site in Egypt.

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Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

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Trial summary

The purpose of training is to evoke improvements in reactive balance, then the training program may be associated with all postural control systems, including the musculoskeletal system, the cognitive system, as well as the somatosensory feedback system, while challenging the body in different environmental situations… Read more about this study

Who is it for?
Ages 50 to 70 yearsHealthy volunteers can take part
What is being tested?
1-Balance Exercises A- Standing with a decreased base B- Graded reaching in standing C- Stepping in different directions D- Walking practice 2-Strength and Balance Exercises A- Sit-to-stand B- Heel r
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
15 May 2025to 15 Jan 2026
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • geriatrics balance disturbance with high risk falling
  • osteoporosis
  • vestibular age related changes
  • female post-menopausal based on history

Who cannot join

  • Hiatus hernia
  • Substantial gastro-esophageal reflux
  • Acute cardiac events
  • Uncontrolled diabetes mellitus
  • Hypertension within the last six weeks
  • Congestive heart failure,
  • Acute exacerbation, exacerbation six months before
  • Active hemoptysis, or malignant disease

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

ibrahim ismail ibrahim Abuzaid, Doctorate contact

+2010006512150 ext. +962797756592

ibrahim_ismail_2011@svu.edu.eg

ibrahim ismail ibrahim Abuzaid, Doctorate contact

+201006512150 ext. +962797756592

ibrahim_ismail_2011@svu.edu.eg

Egypt1 site
  • South Valley university

    Qina

    South valley university South valley university, South valley university, +201006512150, ibrahim_ismail_2011@svu.edu.eg

Other trials in Egypt

About this study

The purpose of training is to evoke improvements in reactive balance, then the training program may be associated with all postural control systems, including the musculoskeletal system, the cognitive system, as well as the somatosensory feedback system, while challenging the body in different environmental situations and unexpected perturbations

Read the detailed description

A study will be conducted at South Valley University Hospital. Subjects have been assigned a consent form before enrolling in the study. This study followed the Consolidated Standards of Reporting Trials guidelines.

Design Parallel double blinded randomized control trial. Subjects Study will be included 60 subjects with geriatrics balance disturbance with high risk falling, osteoporosis, vestibular age related changes, female post-menopausal based on history, physical examination. Male and female subjects meeting the following criteria were included: age ranged from 50 to 70 years, BMI was 18-25 kg/m2, will be divided into two groups, If a patient had a history of hiatus hernia, substantial gastro-esophageal reflux, acute cardiac events, un controlled diabetes mellitus, hypertension within the last six weeks, congestive heart failure, acute exacerbation, exacerbation six months before, active hemoptysis, or malignant disease, they were excluded from the study.

Procedures Assessment

Assessment Tools to effectively monitor the combined effects of these exercises, various assessment tools can be employed:

Balance Tests: Standardized tests functional reach and the Timed Up and Go (TUG) test can provide quantitative measures of balance improvements.

  • Timed Up and Go (TUG) Method: The patient starts in a seated position. The patient stands up upon therapist's command: walks 3 meters, turns around, walks back to the chair and sits down. The time stops when the patient is seated. The subject is allowed to use an assistive device. Normal time ( < 10 sec)
  • Functional Reach Test (FRT): Functional Reach Test is a measure of how high someone can reach while standing. Procedure: If measuring against a wall, the subject stands side on and reaches up with the hand closest to the wall. Keeping the feet flat on the ground, the point of the fingertips is marked then the distance measured. Normal distance 25 centimetres or more (4).

The study Group: training program will be implemented for 60 min per session, 3 times per week for 8 weeks. This intervention included aerobic training on treadmill or bicycle ergometer and mat activities (stretching and muscle strengthening). Balance Exercises \& Strength and Balance Exercises.

  1. Balance Exercises A- Standing with a decreased base B- Graded reaching in standing C- Stepping in different directions D- Walking practice A- Standing with a decreased base B- Graded reaching in standing
  • Feet together and level.
  • Semi-tandem stance.
  • Tandem stance.
  • Stand on one leg.
  • Maintain position for longer
  • Close eyes.
  • Stand on different surfaces e.g. foam rubber mat.
  • Minimize hand support \& Aim to increase time without hand support. • Feet placement- narrower, step standing
  • Reaching further.
  • Reaching in different directions.
  • Reaching down to a stool or the floor.
  • Reaching for heavier objects.
  • Reaching for a full cup of water.
  • Standing on a softer surface eg foam rubber mat.
  • Stepping while reaching. C- Stepping in different directions D- Walking Practice
  • Narrow foot position.
  • Longer steps.
  • Faster steps.
  • Step over objects.
  • Choice component e.g. step forward with left foot.
  • Incorporate pivoting on the non-stepping foot.
  • Use different colors, numbers of letters or a clock face or coins as targets for variety. • Decrease base of support i.e. progress to tandem walk.
  • Increased step size.
  • Increase speed.
  • Change direction.
  • Walk on different surfaces.
  • Walk sideways, backwards.
  • Obstacles to step over and walk around.
  1. Strength and Balance Exercises A- Sit-to-stand B- Heel raise C- Forward step-up D- Lateral step-up E- Half- squats sliding down a wall A- Sit-to-stand B- Heel raise
  • Lowering the height.
  • Don't use hands to push off, cross arms across chest.
  • Changing the nature of the surface (e.g. softer chair). • Decrease hand support.
  • Hold the raise for longer.
  • One leg at a time.
  • Adding weight (either vest or belt)
  • Use a wedge to increase the range of motion. C- Forward- Lateral step-up D- Half- squats sliding down a wall
  • Increasing step height.
  • Adding weight (either vest or belt).
  • Decrease hand support.
  • Step up and over block. • Decrease hand support.
  • Hold the squat for longer.
  • Move a short distance away from the wall.
  • Adding weight (either vest or belt).
  • The person can just do 2 sets of 10- 15 repetitions (10-15) repetition maximum (RM).
  • Frequency 3-4 times per week.
  • Intensity of exercise should be limited so that blood pressures not exceed 170 mmHg.
  • Duration of the exercise divided into warm up of 5-10 min, stimulus phase of 30-45 min and cool down of 5 -10 min.

The control group: The active control group will be received only physical therapy training, which will be provided 3 times per week for 60-min per session. This intervention included aerobic training on treadmill or bicycle ergometer and mat activities (stretching and muscle strengthening).

Being tested
1-Balance Exercises A- Standing with a decreased base B- Graded reaching in standing C- Stepping in different directions D- Walking practice 2-Strength and Balance Exercises A- Sit-to-stand B- Heel r
Keywords
1-Static balance, 2- dynamic balance, 3- Geriatrics populations, 4- Balance exercises, 5-Strengthening exercises
Medical subject headings
Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 1-Balance Exercises A- Standing with a decreased base B- Graded reaching in standing C- Stepping in different directions D- Walking practice 2-Strength and Balance Exercises A- Sit-to-stand B- Heel rProcedure or surgery

    1-Balance Exercises A- Standing with a decreased base B- Graded reaching in standing C- Stepping in different directions D- Walking practice A- Standing with a decreased base B- Graded reaching in standing

    • Feet together and level.
    • Semi-tandem stance.
    • Tandem stance.
    • Stand on one leg.
    • Maintain position for longer
    • Close eyes.
    • Stand on different surfaces e.g. foam rubber mat.
    • Minimize hand support \& Aim to increase time without hand support. • Feet placement- narrower, step standing
    • Reaching further.
    • Reaching in different directions.
    • Reaching down to a stool or the floor.
    • Reaching for heavier objects.
    • Reaching for a full cup of water.
    • Standing on a softer surface eg foam rubber mat.
    • Stepping while reaching. C- Stepping in different directions D- Walking Practice
    • Narrow foot position.
    • Longer steps.
    • Faster steps.
    • Step over objects.
    • Choice component e.g. step forward with left foot.
    • Incorporate pivoting on the non-stepping foot.
    • Use different color
Study groups in NCT06835413
Study groupRoleWhat they receive
The study GroupExperimentaltraining program will be implemented for 60 min per session, 3 times per week for 8 weeks. This intervention included aerobic training on treadmill or bicycle ergometer and mat activities (stretching and muscle strengthening). Balance Exercises \& Strength and Balance Exercises. 1. Balance Exercises A- Standing with a decreased base B- Graded reaching in standing C- Stepping in different directions D- Walking practice 2. Strength and Balance Exercises A- Sit-to-stand B- Heel raise C- Forward step-up D- Lateral step-up E- Half- squats sliding down a wall
Receives: Procedure: 1-Balance Exercises A- Standing with a decreased base B- Graded reaching in standing C- Stepping in different directions D- Walking practice 2-Strength and Balance Exercises A- Sit-to-stand B- Heel r
The control groupActive comparatorThe active control group will be received only physical therapy training, which will be provided 3 times per week for 60-min per session. This intervention included aerobic training on treadmill or bicycle ergometer and mat activities (stretching and muscle strengthening).
Receives: Procedure: 1-Balance Exercises A- Standing with a decreased base B- Graded reaching in standing C- Stepping in different directions D- Walking practice 2-Strength and Balance Exercises A- Sit-to-stand B- Heel r

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Timed Up and Go (TUG) (sec.)

    Assessment Tools to effectively monitor the combined effects of these exercises, various assessment tools can be employed:

    • Timed Up and Go (TUG) Method: The patient starts in a seated position. The patient stands up upon therapist's command: walks 3 meters, turns around, walks back to the chair and sits down. The time stops when the patient is seated. The subject is allowed to use an assistive device. Normal time ( < 10 sec)

    Measured: 8 weeks

  2. Functional Reach Test (FRT) (centimeters)

    Assessment Tools to effectively monitor the combined effects of these exercises, various assessment tools can be employed:

    • Functional Reach Test (FRT): Functional Reach Test is a measure of how high someone can reach while standing. Procedure: If measuring against a wall, the subject stands side on and reaches up with the hand closest to the wall. Keeping the feet flat on the ground, the point of the fingertips is marked then the distance measured. Normal distance 25 centimeters or more

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2025
  2. Study start15 May 2025 (estimated)
  3. Primary completion15 Oct 2025 (estimated)
  4. Study completion15 Jan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study Group: training program will be implemented for 60 min per session, 3 times per week for 8 weeks. This intervention included aerobic training on treadmill or bicycle ergometer and mat activities (stretching and muscle strengthening). Balance Exercises \& Strength and Balance Exercises. 1-Balance Exercises A- Standing with a decreased base B- Graded reaching in standing C- Stepping in different directions D- Walking practice A- Standing with a decreased base B- Graded reaching in standing * Feet together and level. * Semi-tandem stance. * Tandem stance. * Stand on one leg. * Maintain position for longer * Close eyes. * Stand on different surfaces e.g. foam rubber mat. * Minimize hand support \& Aim to increase time without hand support. • Feet placement- narrower, step standing * Reaching further. * Reaching in different directions. * Reaching down to a stool or the floor. * Reaching for heavier objects. * Reaching for a full cup of water. * Standing on a softer surface eg foam
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06835413
Sponsor's protocol ID
South Valley University PT
Status last verified
Feb 2025
First submitted
8 Feb 2025
Last updated
19 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Undecided

Publications

  • Bulat T, Hart-Hughes S, Ahmed S, Quigley P, Palacios P, Werner DC, Foulis P. Effect of a group-based exercise program on balance in elderly. Clin Interv Aging. 2007;2(4):655-60. doi: 10.2147/cia.s204.

    PubMed 18225467
  • Hafstrom A, Malmstrom EM, Terden J, Fransson PA, Magnusson M. Improved Balance Confidence and Stability for Elderly After 6 Weeks of a Multimodal Self-Administered Balance-Enhancing Exercise Program: A Randomized Single Arm Crossover Study. Gerontol Geriatr Med. 2016 Apr 26;2:2333721416644149. doi: 10.1177/2333721416644149. eCollection 2016 Jan-Dec.

    PubMed 28138495
  • Zouita S, Zouhal H, Ferchichi H, Paillard T, Dziri C, Hackney AC, Laher I, Granacher U, Ben Moussa Zouita A. Effects of Combined Balance and Strength Training on Measures of Balance and Muscle Strength in Older Women With a History of Falls. Front Physiol. 2020 Dec 23;11:619016. doi: 10.3389/fphys.2020.619016. eCollection 2020.

    PubMed 33424642
  • Dunsky A. The Effect of Balance and Coordination Exercises on Quality of Life in Older Adults: A Mini-Review. Front Aging Neurosci. 2019 Nov 15;11:318. doi: 10.3389/fnagi.2019.00318. eCollection 2019.

    PubMed 31803048

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