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

NCT04946240 | Completed DMC

• 1 other identifier: REC/00405 Umme Habiba
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Elderly Population

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Supervised (BRACE) Group

EXPERIMENTAL

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

Other: Supervised (BRACE) Group

Conventional Balance Exercises Group

ACTIVE COMPARATOR

The unsupervised home plan included balance and resistance exercise was guided to conventional group

Other: Conventional Balance Exercises Group

Interventions

Supervised (BRACE) Group OTHER

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.

Supervised (BRACE) Group

Conventional Balance Exercises Group OTHER

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

Conventional Balance Exercises Group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

DHQ Hospital

Chakwal, Pakistan

Location

Related Publications (8)

• Masud T, Morris RO. Epidemiology of falls. Age Ageing. 2001 Nov;30 Suppl 4:3-7. doi: 10.1093/ageing/30.suppl_4.3. No abstract available.

  PMID: 11769786 BACKGROUND

• 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.

  PMID: 29540893 BACKGROUND

• 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.

  PMID: 24133524 BACKGROUND

• 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.

  PMID: 24453483 BACKGROUND

• 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. doi: 10.1016/j.apmr.2004.03.019.

  PMID: 15468033 BACKGROUND

• 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. doi: 10.1046/j.1365-2389.2003.51268.x.

  PMID: 12757574 BACKGROUND

• 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.

  PMID: 18218822 BACKGROUND

• 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. doi: 10.1111/j.1532-5415.1991.tb01616.x.

  PMID: 1991946 BACKGROUND

MeSH Terms

Interventions

Braces; Population Groups

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Demography; Population Characteristics

Study Officials

• Arshad Nawaz Malik, PhD

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: June 30, 2021
• Study Start: January 1, 2020
• Primary Completion: July 27, 2021
• Study Completion: July 27, 2021
• Last Updated: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)