Effects of Balance Exercises With and Without Clamshell Exercises After Menopause

December 20, 2024 updated by: Riphah International University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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Study Contact

Study Contact

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Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Balance exercises with clamshell
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
Other: Balance exercise with clamshell
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
Other: Balance exercise
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
Active Comparator: balance exercise
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
Other: Balance exercise
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
baseline and fourth week
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
baseline and fourth week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rabiya Noor, PhD, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/RCR & AHS/24/0521

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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