Effects of Balance Training Exercises Fall Risk Among Elderly Females

NCT ID: NCT06750237

Last Updated: 2024-12-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-15
• Study Completion Date: 2025-06-12

Brief 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. 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

Keywords

Balance Training; stable; unstable; fall

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Isometrics

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

Group Type: EXPERIMENTAL

Unstable surface and isometrics

Intervention Type: 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.

Stable surface and isometrics

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.

Group Type: ACTIVE_COMPARATOR

Stable surface and Isometrics

Intervention Type: 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

Interventions

Stable surface and Isometrics

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

Intervention Type: OTHER

Unstable surface and isometrics

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rabiya Noor, PHD

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Central Contacts

Iqbal Tariq, PHD

Role: CONTACT

Phone: 03338236752

Email: iqbal.tariq@riphah.edu.pk

References

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.

Reference Type: BACKGROUND

PMID: 37601180 (View on PubMed)

Sun 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.

Reference Type: BACKGROUND

PMID: 34886293 (View on PubMed)

van 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.

Reference Type: BACKGROUND

PMID: 33572181 (View on PubMed)

Other Identifiers

REC/RCR & AHS/24/0518

Identifier Type: -

Identifier Source: org_study_id