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

NCT ID: NCT04946240

Last Updated: 2021-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2021-07-27

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.

Conditions

Elderly Population

Study Design

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

Study Groups

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

Group Type: EXPERIMENTAL

Supervised (BRACE) Group

Intervention Type: 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.

Conventional Balance Exercises Group

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

Group Type: ACTIVE_COMPARATOR

Conventional Balance Exercises Group

Intervention Type: 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

Interventions

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.

Intervention Type: OTHER

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arshad Nawaz Malik, PhD

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

DHQ Hospital

Chakwal, , Pakistan

Countries

Pakistan

References

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PMID: 1991946 (View on PubMed)

Other Identifiers

REC/00405 Umme Habiba

Identifier Type: -

Identifier Source: org_study_id