NCT06750263

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2024

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 27, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2025

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

4 months

First QC Date

December 20, 2024

Last Update Submit

December 20, 2024

Conditions

Keywords

BalanceClamshellPostmenupause

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    baseline and fourth week

Study Arms (2)

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

Other: Balance exercise with clamshellOther: 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

Other: Balance exercise

Interventions

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 exercises with clamshell

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

Balance exercises with clamshellbalance exercise

Eligibility Criteria

Age65 Years - 80 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 37343343BACKGROUND
  • Shojaa 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.

    PMID: 32655410BACKGROUND
  • Shubert 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.

    PMID: 21717919BACKGROUND

Study Officials

  • Rabiya Noor, PHD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2024

First Posted

December 27, 2024

Study Start

December 15, 2024

Primary Completion

April 15, 2025

Study Completion

June 15, 2025

Last Updated

December 27, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share