- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06750237
Effects of Balance Training Exercises Fall Risk Among Elderly Females
Effects of Balance Training Exercises Using Unstable and Stable Surfaces on Fall Risk Among Elderly Females
Falls are the second leading cause of unintentional injury deaths globally, and the literature shows that 40% of community-dwelling older adults who are over 65 years old experience fall accidents annually. It also harms the well-being of the elderly, including the lack of access to daily services. Therefore, exercise interventions that target balance, gait, and muscle strength increase can effectively prevent falls in older adults.
A fall prevention program that includes strength and balance training and patient education can improve muscle balance and mental capacity in older women with a history of falls. dimensions of abilities of the elderly are improved by exercise, such as dynamic balance, static balance, participants fear of falling, balance confidence, quality of life, and physical performance. The study will be a randomized clinical trial and will be conducted in Fatima Memorial Hospital, and Atif Rehab Clinic. The sample size is calculated from the open epi tool. Considering the attrition rate (10%) the sample size is calculated to be 36 altogether. This study will be completed in a time duration of 10 months after the approval of the synopsis. Non-probability convenience sampling technique will be used and participants will be recruited in the study after randomization through the lottery method. The subjects will be divided into two groups. Baseline treatment is isometric of the lower limb and bridging. Group A will receive balance training exercises using unstable surfaces and Group B will receive balance training exercises using stable surfaces. The tools that will be used are the Fall Efficacy scale-international (FES-I), Berg Balance Scale ((BBS), and ABC (Activities-Specific Balance Coordination) Scale, and after data collection, data will be analyzed by using SPSS version 26.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Iqbal Tariq, phd
- Phone Number: 03338236752
- Email: Iqbal.tariq@riphah.edu.pk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- Age between 60-75 years old (18)
- Sedentary lifestyle females
- No history of fracture and ligamentous injury in the last 6 months
- Muscular strength should be in at least Grade 3
- Berg Balance Scale score ≤ 49
Exclusion Criteria:
- Any chronic disease such as carcinoma
- Athletes
- Women underwent any surgery (hysterectomy) in the last 2 months
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: Isometrics
will be an interventional group and will be treated by training the patients on unstable surfaces.
The heating pad will be applied for 10 minutes as a warm-up.
Then Isometric exercises of the lower limb and bridging for back extensors strengthening and improving patient confidence will be done.
After that Single leg stance, Toe Raises, standing lower limb abduction and extension with proper support will be done and Mini Squats by stabilizing the patient against the wall or taking the help of an attendant or through a Stabilizing belt will be done.
The session will last for 30 minutes.
It will be conducted 2 months 3 times per week
|
and will be treated by training the patients on stable surfaces.
The heating pad will be applied for 10 minutes as a warm-up.
Then Isometric exercises of the lower limb and bridging for back extensors strengthening and improving patient confidence will be done.
After that Single leg stance, Toe Raises, standing lower limb abduction and extension with proper support will be done and Mini Squats by stabilizing the patient against the wall or taking the help of an attendant or through a Stabilizing belt will be done.
The session will last for 30 minutes.
It will be conducted 2 months 3 times per week.
|
|
Active Comparator: Stable surface and isometrics
will be an interventional group and will be treated by training the patients on stable surfaces.
The heating pad will be applied for 10 minutes as a warm-up.
Then Isometric exercises of the lower limb and bridging for back extensors strengthening and improving patient confidence will be done.
After that Single leg stance, Toe Raises, standing lower limb abduction and extension with proper support will be done and Mini Squats by stabilizing the patient against the wall or taking the help of an attendant or through a Stabilizing belt will be done.
The session will last for 30 minutes.
It will be conducted 2 months 3 times per week.
|
will be treated by training the patients on unstable surfaces.
The heating pad will be applied for 10 minutes as a warm-up.
Then Isometric exercises of the lower limb and bridging for back extensors strengthening and improving patient confidence will be done.
After that Single leg stance, Toe Raises, standing lower limb abduction and extension with proper support will be done and Mini Squats by stabilizing the patient against the wall or taking the help of an attendant or through a Stabilizing belt will be done.
The session will last for 30 minutes.
It will be conducted 2 months 3 times per week
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fall Efficacy Scale
Time Frame: baseline and fourth week
|
Fall efficacy was measured by the Fall-Efficacy Scale-International (FES-I), a widely accepted tool for the evaluation of perceived confidence in performing a range of activities of daily living in the home and community environments, without falling (The FES-I contains 16 items, which are scored on a four-point scale.
The scores range from 16 to 64 points, and higher scores indicate lower self-efficacy (20) The reliability of this tool is 0.94 and the validity is 0.84
|
baseline and fourth week
|
|
Berg Balance Scale
Time Frame: baseline and fourth week
|
The BBS is considered the "gold standard" for assessing balance, and it can evaluate dynamic and static balance functions simultaneously.
It consists of 14 tasks of varying difficulty, and each item is scored on a scale of 0-4.31
The maximum score is 56, and higher scores indicate better performance.
The reliability of this tool is 0.96
|
baseline and fourth week
|
|
ABC (Activities-Specific Balance Coordination) Scale
Time Frame: baseline and fourthweek
|
The scale includes 16 activities of daily living, such as walking around the house, sweeping the floor, and walking in a crowded mall, which needs complex posture control abilities (including posture stability and orientation) for adaptation to complex environments to maintain balance.
|
baseline and fourthweek
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rabiya Noor, PhD, Riphah International University
Publications and helpful links
General Publications
- Sun M, Min L, Xu N, Huang L, Li X. The Effect of Exercise Intervention on Reducing the Fall Risk in Older Adults: A Meta-Analysis of Randomized Controlled Trials. Int J Environ Res Public Health. 2021 Nov 29;18(23):12562. doi: 10.3390/ijerph182312562.
- Sadaqa M, Nemeth Z, Makai A, Premusz V, Hock M. Effectiveness of exercise interventions on fall prevention in ambulatory community-dwelling older adults: a systematic review with narrative synthesis. Front Public Health. 2023 Aug 3;11:1209319. doi: 10.3389/fpubh.2023.1209319. eCollection 2023.
- van Hoof J, Marston HR. Age-Friendly Cities and Communities: State of the Art and Future Perspectives. Int J Environ Res Public Health. 2021 Feb 9;18(4):1644. doi: 10.3390/ijerph18041644.
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
Other Study ID Numbers
- REC/RCR & AHS/24/0518
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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