Effects of Supervised (BRACE) Balance, Resistance, Aerobic &Cognitive Exercises

Not Applicable

Completed

• Conditions: Elderly Population
• Interventions: Other: Supervised (BRACE) Group; Other: Conventional Balance Exercises Group

• Registration Number: NCT04946240
• Lead Sponsor: Riphah International University

Brief Summary

In the elderly risk of fall increases due to balance dysfunction, cognitive impairment and low vision. In this research, the aim is to find the effects of Supervised BRACE (Balance, Resistance, Aerobic, Cognitive Exercises) protocol on mobility to reduce the risk of fall in the elderly. Randomized controlled trial 10-12 weeks follow-up. The sample size is 40. The subjects are divided into two groups, 20 subjects in the control group and 20 in the experimental group. The study duration is of 6 months. The sampling technique will be purposive sampling and consecutive random assignment through the sealed envelope method. Individuals of age 60-80, either gender with Berg balance score (BBS) 20-40 will be included. Individuals with musculoskeletal conditions (fractures, severe arthritis), neurological conditions like Epilepsy, Parkinson, Alzheimer's, Impaired cognition and other systemic diseases or co-morbidities will be excluded. Assessments tools that will be used in the study are Mini-Mental State Exam, Berg balance Scale, timed up and go test (TUG), elderly mobility scale, Fullerton Advanced Balance (FAB) scale, Activities of Balance Confidence.

Detailed Description

In terms of morbidity and mortality fall is a major concern in older adults. Fall is defined as unintentional contact with the ground. Tinetti in 1988 defined fall as "an event in which a person rest unintentionally on the ground or lower surface". There are many reasons for fall which can be intrinsic or extrinsic. The risk factors of fall can be ageing (e.g. cognitive impairment, poor balance or low vision), nutrition (vitamin D and calcium deficiency), medication (sedatives, antidepressants etc), environmental factors (improper shoes, poor lighting and unsafe stairs) and lack of exercise.

Previous studies considered age 60 and above in the geriatric population. The number of falls increases day by day due to balance dysfunction which is the key impairment. Age 60 and above along with any impairment or disease which makes a person weak can be included in the group of geriatric population. The fact supported by previous researches that the person who involved in rehabilitation therapies can decrease fall rate and fall associated problems. Through these rehabilitation exercises Activity of Daily Living (ADLs) can be improved and disabilities could be prevented. Wii Fit gaming system can be used to uplift lifestyle and improve balance in the geriatric population.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2021-06-22
• Study First Submitted QC: 2021-06-22
• Study First Posted: 2021-06-30
• Primary Completion: 2021-07-27
• Study Completion: 2021-07-27
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-27
• Last Update Posted: 2021-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Individuals of age 60 -80 years
• Either gender
• Berg balance score 21-40

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Exclusion Criteria

• Musculoskeletal conditions (fractures, severe arthritis grade iii and iv)
• Neurological conditions like Epilepsy, Parkinson, Alzheimer's, Impaired cognition
• Other systemic diseases or co-morbidities

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supervised (BRACE) Group	Supervised (BRACE) Group	the self-developed protocol (BRACE) is used in the experiment with a combination of balance, resistance, aerobic and cognitive exercises for 12 weeks with repetition of different tasks
Conventional Balance Exercises Group	Conventional Balance Exercises Group	The unsupervised home plan included balance and resistance exercise was guided to conventional group

Primary Outcome Measures

Name	Time	Method
Berg Balance Test	week 12	authentic tool to assess the balance. It is used for the assessment of static and dynamic balance. It is additionally utilized for assessment of functional balance and risk of fall in the elderly. It is a 14 Item scale, each item has a range of score from 0-4, where a high score (4) indicates a decrease in fall risk, good balance and perform task independently while a lower score (0) demonstrates poor balance, increased danger of fall and totally dependent. 56 are the highest score of berg balance
The Timed Up and Go Test	week 12	The Timed Up and Go Test (TUG) is a basic, reasonable and cheap method that was created to assess the mobility and gait in the elderly. The TUG involves fundamental regular movements: stand up from a seat, walking a distance of 3 meters, pivot, move back, and take a seat once again. The result is the time taken to play out this arrangement of developments.; The interpretation of TUG demonstrates that individuals with TUG score \<10 seconds are highly mobile, \<20 seconds are generally independent and \> 20 for mobility impairment
ELDERLY MOBILITY SCALE	week 12	The Elderly Mobility Scale (EMS) is a simple and quick tool used for the assessment of mobility and function in elderly. EMS is the 7-item scale with the total score of 20. The interpretation of EMS demonstrates , individuals with score \>14 are perform their ADLs independently with good mobility, score ranges between 10-13- these individuals are at borderline according to their safe mobility and independence while score \< 10 are generally dependent in performing ADLs and have poor mobility
Montreal Cognitive Assessment (MoCA)	week 12	The Montreal Cognitive Assessment (MoCA) is used for the screening of cognitive impairment. There is no effective instrument for the early detection of mild cognitive changes. MoCA is a successful screening test Scores of MoCA ranges from 0-30. Interpretation of MoCA indicates that score of 26 and above normal, 18 - 25 score indicates mild cognitive impairment, 10 - 18 score considered moderate cognitive impairment while \<10 considered severe cognitive impairment exists for the screening of mild cognitive impairment.
ACTIVITIES-SPECIFIC BALANCE CONFIDENCE	week 12	The Activities-specific Balance Confidence (ABC) scale was produced to evaluate the confidence level in performing Score of ABC scale ranges from 0%-100%, 0% means (no confidence) and 100% means (absolutely good). The interpretation of ABC scale demonstrates \>80% shows good level of confidence in physical activity, 50-80% indicates a moderate level of confidence and \<50% shows a low level of confidence in physical working specific task without losing balance or getting to be unsteady.
FULLERTON ADVANCE BALANCE (FAB) SCALE	week 12	Fullerton Advanced Balance (FAB) is a valid and reliable scale used for the assessment of balance in higher-working elderly. Both static and dynamic balance can be measured through FAB. The test was found to separate among members of fluctuating abilities of balance. FAB is 10-item scale consists of 5-point ranged (0-4) with total score of 0-40 points possible (higher scores are better). Items are scored on a 5-point ordinal scale (0-4).

Trial Locations

Locations (1)

DHQ Hospital; 🇵🇰 Chakwal, Pakistan