- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06835413
Monitoring Combined Effect of Balance and Strengthening Exercises on Static and Dynamic Balance in Elderly Populations
Study Overview
Status
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.
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.
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).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: ibrahim ismail ibrahim Abuzaid, Doctorate
- Phone Number: +962797756592 +2010006512150
- Email: ibrahim_ismail_2011@svu.edu.eg
Study Contact Backup
- Name: ibrahim ismail ibrahim Abuzaid, Doctorate
- Phone Number: +962797756592 +201006512150
- Email: ibrahim_ismail_2011@svu.edu.eg
Study Locations
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-
-
Qena, Egypt
- South Valley University
-
Contact:
- South valley university South valley university, South valley university
- Phone Number: +201006512150
- Email: ibrahim_ismail_2011@svu.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- geriatrics balance disturbance with high risk falling
- osteoporosis
- vestibular age related changes
- female post-menopausal based on history
Exclusion Criteria:
- 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
Study Plan
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: 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
|
|
Active Comparator: 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).
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Timed Up and Go (TUG) (sec.)
Time Frame: 8 weeks
|
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) |
8 weeks
|
|
Functional Reach Test (FRT) (centimeters)
Time Frame: 8 weeks
|
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 |
8 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- South Valley University PT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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