MenopauseNCT06750263
Effects of Balance Exercises With and Without Clamshell Exercises After Menopause
A study testing Balance exercise with clamshell and Balance exercise in people with Menopause, run by Riphah International University.
Trial summary
Exercise-based balance intervention is structured program of physical exercises intended to enhance balance, stability, and clamshell exercises are known as an exercise-based balance intervention. Read more about this study
- Who is it for?
- Ages 65 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- Balance exercise with clamshell and Balance exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2024to 15 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 65 to 80 years
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- age 65 years or older;
- having significant concerns about their balance
- participants to be living independently in the community
- Berg's Balance Scale scores more than 41/56 indicating minimal fall risk were included in the study
Who cannot join
- Participants were excluded from the study if their vision was compromised so that they were unable to see objects on the floor or recognize the instructor's movements
- progressive neurologic disease which could impair balance
- hypertensive
- unable to understand, speak, or hear
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 Exercises With and Without Clamshell Exercises on Physical Performanace and Balance After Menopause
Exercise-based balance intervention is structured program of physical exercises intended to enhance balance, stability, and clamshell exercises are known as an exercise-based balance intervention. A crucial component of physical therapy and fitness regimens targeted at enhancing stability, reducing the risk of falls, and promoting general physical health is exercise-based balance therapies. Women's ability to function both physically and mentally can be significantly impacted by menopause. To find out the effects of an exercise based balance intervention on physical and clamshell exercises after menopause Certain consequences can be lessened by address these alterations with focused interventions.These will be a randomized clinical trial and will be conducted in Bhawalpur Victoria Hospital and Mehran Rehab Clinic. This study will be completed in the time duration of 10 months after the approval of Synopsis. Non probability convenience sampling technique will be used and participants will be recruited in study after the randomization.80 participants with age between 50-65 years will be included in the study according to the inclusion criteria. Group A will receive balance exercises and clamshell exercises Group B will be recieve only balance exercises the tool that will be used are the sit and raised test , y balance test, Romberg test for check the balance. Timed raised chair task for check the strength . timed up and go for check the mobility . heel shin touch test for check the coordination. Time shuttle runs for check the speed. Step test for check the power after data collection, data will be analyzed by using SPPSS 26.
- Conditions
- Menopause
- Being tested
- Balance exercise with clamshell, Balance exercise
- Keywords
- Balance, Clamshell, Postmenupause
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance exercise with clamshellOther
balance was assessed by the Berg's Balance Scale exercise. Participants were instructed to walk (step) from one end of the mat to the other according to the step pattern provided. When reached the end of the mat, instructed to return to their starting position by walking normally off the mat and starting the next stepping. repeat every sequence five times and then started a new pattern. Duration would be 30 min. clamshell exercises a Participants were instructed to lie on their side with the weaker limb facing upwards. Both hips were flexed at 45 degrees, knees flexed at 90 degrees, and neither the feet nor the back were in contact with the wall. While keeping both heels and the first metatarsal head together, participants were instructed to separate their knees and rotate the weaker limb upward. They were advised not to tilt the limb backwards and to maintain a neutral pelvic position 3,5 sets for 10 repetations twice a week for 12 weeks
Balance exerciseOther
Participants were instructed to lie on their side with the weaker limb facing upwards. Both hips were flexed at 45 degrees, the knees were flexed at 90 degrees, and neither the feet nor the back were in contact with the wall. While keeping both heels and the first metatarsal head together, participants were instructed to separate their knees and rotate the weaker limb upward. They were advised not to tilt the limb backwards and to maintain a neutral pelvic position 3,5 sets for 10 repetations twice a week for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Balance exercises with clamshell | Experimental | balance was assessed by the Berg's Balance Scale exercise. Participants were instructed to walk (step) from one end of the mat to the other according to the step pattern provided. When reached the end of the mat, instructed to return to their starting position by walking normally off the mat and starting the next stepping. repeat every sequence five times and then started a new pattern. Duration would be 30 min. clamshell exercises a Participants were instructed to lie on their side with the weaker limb facing upwards. Both hips were flexed at 45 degrees, knees flexed at 90 degrees, and neither the feet nor the back were in contact with the wall. While keeping both heels and the first metatarsal head together, participants were instructed to separate their knees and rotate the weaker limb upward. They were advised not to tilt the limb backwards and to maintain a neutral pelvic position 3,5 sets for 10 repetations twice a week for 12 weeks Receives: Other: Balance exercise with clamshell; Other: Balance exercise |
| balance exercise | Active comparator | Group B will be recieve balance exercises balance was assessed by the Berg's Balance Scale exercise include square stepping exercises The SSE comprised a progression of forward, in reverse, sidelong, and inclining steps. Participants were instructed to walk (step) from one end of the mat to the other according to the step pattern provided. When they reached the end of the mat, they were instructed to return to their starting position by walking normally off the mat and starting the next stepping. Each participant repeated every sequence five times and then started a new pattern. Duration of exercise would be 30 min Receives: Other: Balance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time shuttle run
A maximal multistage 20 m shuttle run test was designed to determine the maximal aerobic power of menopausal females Subjects run back and forth on a 20 m course and must touch the 20 m line; at the same time The reliability of the interval shuttle run test (ISRT) as a submaximal and maximal field test to measure intermittent endurance capacity was examined. ISRT. Relative reliability was high (intraclass correlation coefficient ≥ 0.86). A maximal multistage 20 m shuttle run test was designed to determine the maximal aerobic power of menopausal females Subjects run back and forth on a 20 m course and must touch the 20 m line; at the same time. The reliability of the interval shuttle run test (ISRT) as a submaximal and maximal field test to measure intermittent endurance capacity was examined. ISRT.
Measured: baseline and fourth week
Time up and go
TUG measures the time a person needs to get up out of a chair, walk three meters and return to the chair. This is measured in seconds with a handheld stopwatch. Patients performed the TUG two times and for each patient, the mean of the two time measurements would be a score of less than or equal to 20 seconds on the TUG was considered a normal score
Measured: baseline and fourth week
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 completion15 Apr 2025 (estimated)
- Study completion15 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 MenopauseStudies 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
- 80 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
- NCT06750263
- Sponsor's protocol ID
- REC/RCR & AHS/24/0521
- Status last verified
- Dec 2024
- First submitted
- 20 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Walsh GS, Delextrat A, Bibbey A. The comparative effect of exercise interventions on balance in perimenopausal and early postmenopausal women: A systematic review and network meta-analysis of randomised, controlled trials. Maturitas. 2023 Sep;175:107790. doi: 10.1016/j.maturitas.2023.107790. Epub 2023 Jun 16.
PubMed 37343343Shojaa M, Von Stengel S, Schoene D, Kohl M, Barone G, Bragonzoni L, Dallolio L, Marini S, Murphy MH, Stephenson A, Manty M, Julin M, Risto T, Kemmler W. Effect of Exercise Training on Bone Mineral Density in Post-menopausal Women: A Systematic Review and Meta-Analysis of Intervention Studies. Front Physiol. 2020 Jun 23;11:652. doi: 10.3389/fphys.2020.00652. eCollection 2020.
PubMed 32655410Shubert TE, McCulloch K, Hartman M, Giuliani CA. The effect of an exercise-based balance intervention on physical and cognitive performance for older adults: a pilot study. J Geriatr Phys Ther. 2010 Oct-Dec;33(4):157-64.
PubMed 21717919
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 Exercises With and Without Clamshell Exercises on Physical Performanace and Balance After Menopause
- ClinicalTrials.gov ID
- NCT06750263
- Acronym / sponsor ID
- REC/RCR & AHS/24/0521
- Conditions
- Menopause
- Keywords
- Balance, Clamshell, Postmenupause
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (estimated)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 15 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.
Exercise-based balance intervention is structured program of physical exercises intended to enhance balance, stability, and clamshell exercises are known as an exercise-based balance intervention. A crucial component of physical therapy and fitness regimens targeted at enhancing stability, reducing the risk of falls, and promoting general physical health is exercise-based balance therapies. Women's ability to function both physically and mentally can be significantly impacted by menopause. To find out the effects of an exercise based balance intervention on physical and clamshell exercises after menopause Certain consequences can be lessened by address these alterations with focused interventions.These will be a randomized clinical trial and will be conducted in Bhawalpur Victoria Hospital and Mehran Rehab Clinic. This study will be completed in the time duration of 10 months after the approval of Synopsis. Non probability convenience sampling technique will be used and participants will be recruited in study after the randomization.80 participants with age between 50-65 years will be included in the study according to the inclusion criteria. Group A will receive balance exercises and clamshell exercises Group B will be recieve only balance exercises the tool that will be used are the sit and raised test , y balance test, Romberg test for check the balance. Timed raised chair task for check the strength . timed up and go for check the mobility . heel shin touch test for check the coordination. Time shuttle runs for check the speed. Step test for check the power after data collection, data will be analyzed by using SPPSS 26.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balance exercises with clamshell | Experimental | Other: Balance exercise with clamshell, Other: Balance exercisebalance was assessed by the Berg's Balance Scale exercise. Participants were instructed to walk (step) from one end of the mat to the other according to the step pattern provided. When reached the end of the mat, instructed to return to their starting position by walking normally off the mat and starting the next stepping. repeat every sequence five times and then started a new pattern. Duration would be 30 min. clamshell exercises a Participants were instructed to lie on their side with the weaker limb facing upwards. Both hips were flexed at 45 degrees, knees flexed at 90 degrees, and neither the feet nor the back were in contact with the wall. While keeping both heels and the first metatarsal head together, participants were instructed to separate their knees and rotate the weaker limb upward. They were advised not to tilt the limb backwards and to maintain a neutral pelvic position 3,5 sets for 10 repetations twice a week for 12 weeks |
| balance exercise | Active comparator | Other: Balance exerciseGroup B will be recieve balance exercises balance was assessed by the Berg's Balance Scale exercise include square stepping exercises The SSE comprised a progression of forward, in reverse, sidelong, and inclining steps. Participants were instructed to walk (step) from one end of the mat to the other according to the step pattern provided. When they reached the end of the mat, they were instructed to return to their starting position by walking normally off the mat and starting the next stepping. Each participant repeated every sequence five times and then started a new pattern. Duration of exercise would be 30 min |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- age 65 years or older;
- having significant concerns about their balance
- participants to be living independently in the community
- Berg's Balance Scale scores more than 41/56 indicating minimal fall risk were included in the study
Key exclusion criteria (4 listed)
- Participants were excluded from the study if their vision was compromised so that they were unable to see objects on the floor or recognize the instructor's movements
- unable to understand, speak, or hear
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 |
|---|---|---|
| Balance exercise with clamshellbalance was assessed by the Berg's Balance Scale exercise. Participants were instructed to walk (step) from one end of the mat to the other according to the step pattern provided. When reached the end of the mat, instructed to return to their starting position by walking normally off the mat and starting the next stepping. repeat every sequence five times and then started a new pattern. Duration would be 30 min. clamshell exercises a Participants were instructed to lie on their side with the weaker limb facing upwards. Both hips were flexed at 45 degrees, knees flexed at 90 degrees, and neither the feet nor the back were in contact with the wall. While keeping both heels and the first metatarsal head together, participants were instructed to separate their knees and rotate the weaker limb upward. They were advised not to tilt the limb backwards and to maintain a neutral pelvic position 3,5 sets for 10 repetations twice a week for 12 weeks | Other | Balance exercises with clamshell |
| Balance exerciseParticipants were instructed to lie on their side with the weaker limb facing upwards. Both hips were flexed at 45 degrees, the knees were flexed at 90 degrees, and neither the feet nor the back were in contact with the wall. While keeping both heels and the first metatarsal head together, participants were instructed to separate their knees and rotate the weaker limb upward. They were advised not to tilt the limb backwards and to maintain a neutral pelvic position 3,5 sets for 10 repetations twice a week for 12 weeks | Other | Balance exercises with clamshell, balance exercise |
Primary outcome
Time shuttle run
Time frame: baseline and fourth week
A maximal multistage 20 m shuttle run test was designed to determine the maximal aerobic power of menopausal females Subjects run back and forth on a 20 m course and must touch the 20 m line; at the same time The reliability of the interval shuttle run test (ISRT) as a submaximal and maximal field test to measure intermittent endurance capacity was examined. ISRT. Relative reliability was high (intraclass correlation coefficient ≥ 0.86). A maximal multistage 20 m shuttle run test was designed to determine the maximal aerobic power of menopausal females Subjects run back and forth on a 20 m course and must touch the 20 m line; at the same time. The reliability of the interval shuttle run test (ISRT) as a submaximal and maximal field test to measure intermittent endurance capacity was examined. ISRT.
Time up and go
Time frame: baseline and fourth week
TUG measures the time a person needs to get up out of a chair, walk three meters and return to the chair. This is measured in seconds with a handheld stopwatch. Patients performed the TUG two times and for each patient, the mean of the two time measurements would be a score of less than or equal to 20 seconds on the TUG was considered a normal score
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 37343343Walsh GS, Delextrat A, Bibbey A. The comparative effect of exercise interventions on balance in perimenopausal and early postmenopausal women: A systematic review and network meta-analysis of randomised, controlled trials. Maturitas. 2023 Sep;175:107790. doi: 10.1016/j.maturitas.2023.107790. Epub 2023 Jun 16.
- Background: PubMed 32655410Shojaa M, Von Stengel S, Schoene D, Kohl M, Barone G, Bragonzoni L, Dallolio L, Marini S, Murphy MH, Stephenson A, Manty M, Julin M, Risto T, Kemmler W. Effect of Exercise Training on Bone Mineral Density in Post-menopausal Women: A Systematic Review and Meta-Analysis of Intervention Studies. Front Physiol. 2020 Jun 23;11:652. doi: 10.3389/fphys.2020.00652. eCollection 2020.
- Background: PubMed 21717919Shubert TE, McCulloch K, Hartman M, Giuliani CA. The effect of an exercise-based balance intervention on physical and cognitive performance for older adults: a pilot study. J Geriatr Phys Ther. 2010 Oct-Dec;33(4):157-64.
- 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 Balance exercise with clamshell and Balance exercise in people with Menopause, 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 4 inclusion and 4 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?
Time shuttle run (time frame: baseline and fourth week). The study lists 2 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 NCT06750263, 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.