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NCT Number: NCT06750237

Effects of Balance Training Exercises 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.

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Key information

Conditions

Age range

60 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stable surface and Isometrics

Other

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 isometrics

Other

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.

Primary outcomes

  1. 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

  2. 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

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Iqbal Tariq, PHD

CONTACT

[email protected]

03338236752

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Balance Training Exercises Using Unstable and Stable Surfaces on Fall Risk Among Elderly Females

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 27, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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