Elderly FemalesNCT06750237
Effects of Balance Training Exercises Fall Risk Among Elderly Females
A study testing Stable surface and Isometrics and Unstable surface and isometrics in people with Elderly Females, run by Riphah International University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Elderly Females
- What is being tested?
- Stable surface and Isometrics and Unstable surface and isometrics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2024to 12 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Any chronic disease such as carcinoma
- Athletes
- Women underwent any surgery (hysterectomy) in the last 2 months
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Elderly Females
- Being tested
- Stable surface and Isometrics, Unstable surface and isometrics
- Keywords
- Balance Training, stable, unstable, fall
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stable surface and IsometricsOther
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
Unstable surface and isometricsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Isometrics | Experimental | 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 Receives: Other: Unstable surface and isometrics |
| Stable surface and isometrics | Active comparator | 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. Receives: Other: Stable surface and Isometrics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fall Efficacy Scale
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
Measured: baseline and fourth week
Berg Balance Scale
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
Measured: baseline and fourth week
ABC (Activities-Specific Balance Coordination) Scale
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.
Measured: baseline and fourthweek
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start15 Dec 2024 (estimated)
- Primary completion12 Apr 2025 (estimated)
- Study completion12 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Elderly FemalesStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rabiya Noor, PHD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750237
- Sponsor's protocol ID
- REC/RCR & AHS/24/0518
- Status last verified
- Dec 2024
- First submitted
- 20 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37601180Sun 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.
PubMed 34886293van 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.
PubMed 33572181
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Balance Training Exercises Using Unstable and Stable Surfaces on Fall Risk Among Elderly Females
- ClinicalTrials.gov ID
- NCT06750237
- Acronym / sponsor ID
- REC/RCR & AHS/24/0518
- Conditions
- Elderly Females
- Keywords
- Balance Training, stable, unstable, fall
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (estimated)
- Primary completion
- 12 Apr 2025 (estimated)
- Study completion
- 12 Jun 2025 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isometrics | Experimental | Other: Unstable surface and isometricswill 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 |
| Stable surface and isometrics | Active comparator | Other: Stable surface and Isometricswill 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. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Any chronic disease such as carcinoma
- Athletes
- Women underwent any surgery (hysterectomy) in the last 2 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stable surface and Isometricswill 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 | Other | Stable surface and isometrics |
| Unstable surface and isometricsand 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. | Other | Isometrics |
Primary outcome
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
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Background: PubMed 37601180Sadaqa 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.
- Background: PubMed 34886293Sun 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.
- Background: PubMed 33572181van 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rabiya Noor, PHD principal investigator
Riphah International University
Questions about this trial
What is this clinical trial studying?
A study testing Stable surface and Isometrics and Unstable surface and isometrics in people with Elderly Females, run by Riphah International University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iqbal Tariq, PHD (03338236752, iqbal.tariq@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fall Efficacy Scale (time frame: baseline and fourth week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06750237, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.