Comparison of (Balance, Resistance, Aerobic and Cognitive Exercises) & (Balance Resistance Exercise)

NCT ID: NCT04293952

Last Updated: 2021-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2020-12-30

Brief Summary

In the elderly risk of fall increased due to impaired balance and gait, cognitive impairment, sensory defects and reduced muscle strength. In this research, the aim of the study is to compare the effect of BRACE (balance, resistance, aerobic exercises and cognitive exercises) and BRE (balance resistance Exercises) on fall risk and mobility level in the elderly population. Randomized control trial study of 6 weeks follows up. The sample size is 40. The patients will be randomly divided into two groups: BRACE and BRE. The patients will get a supervised protocol for 3 days per week for 3 to 9 week. The measurement will be taken at baseline, after 3, 6 and 9 weeks. The study duration is of 8 months. Sampling technique will be purposive sampling and random assignment through the sealed envelope method. Individuals of age above 60 years, either gender with Berg balance score 20-40, MMSE will be included. Individuals with Musculoskeletal conditions (fractures, severe arthritis grade iii and i), Neurological conditions like Epilepsy, Parkinson and Other systemic diseases or co-morbidities will be excluded. Assessment tools will be MMSE, Berg balance scale, TUG, 6 minutes walk test. Data will be analyzed through the Statistical Package for Social Sciences (SPSS) 20.

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. 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), nutritional (vitamin D and calcium deficiency), medication (sedatives, antidepressants etc), environmental factors (improper shoes, poor lightning and unsafe stairs) and lack of exercise.

The most common mechanism of injury in the elderly population is falling about 30%-50% of falls in the elderly result in minor injuries, including bruises, abrasions, and lacerations, but an estimated 10% of all falls in seniors cause major injuries, including intracranial injuries and fractures. One per cent of all falls in this population result in hip fractures, which pose a significant risk for post-fall morbidity and mortality.

A case series was conducted at Shifa Tamer-e-Millat University Islamabad from January-July 2016. Sixteen adults more than 60 years age (07 males and 09 females) were recruited through convenient sampling. The specified Wii fit plus training was provided to all patients and the games included the Soccer heading, Ski slalom, table tilt and yoga. The Wii fit training improves the balance and reduces the fall risk in the older population.

A study was conducted to evaluate the effects of virtual reality and strength training on the balance, fear of falling and handgrip strength of older women with a history of falls. Balance training consisting of virtual reality and strengthening exercises proved to be an effective tool to reduce the fear of falling and to improve the mobility of elderly female fallers and may be an acceptable treatment for the prevention of falls and balance recovery.

Older adults are prone to fall due to ageing. Mostly older adults aged 60 and above fall due to cognitive impairment, balance problems and physiological functioning. Many studies reported that prevention of fall is possible by adopting a healthy lifestyle, environmental modification, exercise and education. Exercise plays a very important role in fall prevention e.g exercise and tai chi training target balance, flexibility and strength can reduce fall and harm related to fall. Although it does not show a marked difference enjoyable exercise program training is beneficial to achieve healthy outcomes.

In the last few years, several journals had been published specifically on balance training exercises, resistance exercises and aerobic exercises separately. A new tool has been designed for fall risk reduction and to mobility in elderly is BRACE (Balance, Resistance, Aerobic, Cognition Exercises).

A randomized control trial was conducted to compare the effects of S-BRACE (Balance, Resistance, Aerobic, Cognition Exercises) versus conventional therapy on functional balance, mobility and fall risk reduction in elderly with moderate fall risk. It is concluded supervised BRACE training has a better outcome in improving dynamic balance, mobility and risk of fall reduction. Cognitive improvement was observed in both groups.

However, investigation on BRACE protocol is rare in literature. My aim is to compare the effect of BRACE protocol with BRE protocol on mobility and fall risk reduction in the elderly.

Conditions

Elderly Population

Study Design

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

Study Groups

BRACE group

BRACE include combination of exercises including, Balance, Resistance, Aerobic, Cognition Exercises.

Group Type: EXPERIMENTAL

Balance, Resistance, Aerobic, Cognition Exercises (BRACE)

Intervention Type: OTHER

BRACE is a combination of different exercises including Balance, Resistance, Aerobic, Cognition for fall risk reduction and to mobility in the elderly.

BRE group

this group include Balance Resistance Exercises Stretching Range Of Motion exercises Ankle flexion Ankle extension Knee flexion Knee extension Hip flexion Hip extension Hip adduction Hip abduction

Group Type: ACTIVE_COMPARATOR

Balance Resistance Exercise (BRE)

Intervention Type: OTHER

this is the simple conventional treatment for the elderly in balance problems including warm-up, resistance exercises and cool-down exercises.

Interventions

Balance, Resistance, Aerobic, Cognition Exercises (BRACE)

BRACE is a combination of different exercises including Balance, Resistance, Aerobic, Cognition for fall risk reduction and to mobility in the elderly.

Intervention Type: OTHER

Balance Resistance Exercise (BRE)

this is the simple conventional treatment for the elderly in balance problems including warm-up, resistance exercises and cool-down exercises.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Berg balance score 20-40
• Mini-mental state examination not less than 23

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
• 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

Riphah International University

Lahore, Punjab Province, Pakistan

Countries

Pakistan

References

Halvarsson A, Franzen E, Stahle A. Balance training with multi-task exercises improves fall-related self-efficacy, gait, balance performance and physical function in older adults with osteoporosis: a randomized controlled trial. Clin Rehabil. 2015 Apr;29(4):365-75. doi: 10.1177/0269215514544983. Epub 2014 Aug 20.

Reference Type: BACKGROUND

PMID: 25142277 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29540893 (View on PubMed)

Prata MG, Scheicher ME. Effects of strength and balance training on the mobility, fear of falling and grip strength of elderly female fallers. J Bodyw Mov Ther. 2015 Oct;19(4):646-50. doi: 10.1016/j.jbmt.2014.11.013. Epub 2014 Dec 5.

Reference Type: BACKGROUND

PMID: 26592222 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24453483 (View on PubMed)

Other Identifiers

REC/Lhr/20/2010 Ayesha Batool

Identifier Type: -

Identifier Source: org_study_id