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

Elderly Population Clinical Trial

Official title:

Effects of Supervised BRACE (Balance, Resistance, Aerobic, Cognitive Exercises) Protocol on Mobility in Elderly With Fall Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04946240
• Other study ID #: REC/00405 Umme Habiba
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: July 27, 2021

Study information

• Verified date: August 2021
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 27, 2021
• Est. primary completion date: July 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

Inclusion Criteria:

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

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

Related Conditions & MeSH terms

• Elderly Population

Intervention

Other:
• Supervised (BRACE) Group
Supervised (BRACE) protocol include static, dynamic and anticipatory balance exercises, chair rise, stair climbing and floor transfer comes under the category of resistance exercises. 6 minutes walk test, marching in space and cycling comes in aerobic. count reverse for 50 remember 5 words, 5 animals, repeat 5 words, spell forward and backwards and cont even numbers comes in cognitive exercises.
• Conventional Balance Exercises Group
The home plan included Balance and Resistance exercises of BRACE protocol were provided to the control group but that was not supervised. Control group participants were also same assessed as the S-BRACE group. Before giving the training plan for home, it was elaborated in detail. For the convenience of participants, the BRACE protocol was also translated into Urdu and was given in the printed form. The data were collected at baseline, after 3 weeks, 6, 9 and then after 12 weeks of training

Locations

Country	Name	City	State
Pakistan	DHQ Hospital	Chakwal

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (8)

Afridi A, Malik AN, Ali S, Amjad I. Effect of balance training in older adults using Wii fit plus. J Pak Med Assoc. 2018 Mar;68(3):480-483. — View Citation

Heyn P, Abreu BC, Ottenbacher KJ. The effects of exercise training on elderly persons with cognitive impairment and dementia: a meta-analysis. Arch Phys Med Rehabil. 2004 Oct;85(10):1694-704. — View Citation

Masud T, Morris RO. Epidemiology of falls. Age Ageing. 2001 Nov;30 Suppl 4:3-7. Review. — View Citation

Muir SW, Berg K, Chesworth B, Speechley M. Use of the Berg Balance Scale for predicting multiple falls in community-dwelling elderly people: a prospective study. Phys Ther. 2008 Apr;88(4):449-59. doi: 10.2522/ptj.20070251. Epub 2008 Jan 24. — View Citation

Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. — View Citation

Steadman J, Donaldson N, Kalra L. A randomized controlled trial of an enhanced balance training program to improve mobility and reduce falls in elderly patients. J Am Geriatr Soc. 2003 Jun;51(6):847-52. — View Citation

Ungar A, Rafanelli M, Iacomelli I, Brunetti MA, Ceccofiglio A, Tesi F, Marchionni N. Fall prevention in the elderly. Clin Cases Miner Bone Metab. 2013 May;10(2):91-5. Review. — View Citation

Zhuang J, Huang L, Wu Y, Zhang Y. The effectiveness of a combined exercise intervention on physical fitness factors related to falls in community-dwelling older adults. Clin Interv Aging. 2014;9:131-40. doi: 10.2147/CIA.S56682. Epub 2014 Jan 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Berg Balance Test	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	week 12
Primary	Montreal Cognitive Assessment (MoCA)	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.	week 12
Primary	The Timed Up and Go Test	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	week 12
Primary	ACTIVITIES-SPECIFIC BALANCE CONFIDENCE	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.	week 12
Primary	ELDERLY MOBILITY SCALE	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	week 12
Primary	FULLERTON ADVANCE BALANCE (FAB) SCALE	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).	week 12