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临床试验/NCT04946240
NCT04946240已完成不适用

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

Riphah International University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Berg Balance Test

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

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

干预措施: Supervised (BRACE) Group (Other)

Conventional Balance Exercises Group

Active Comparator

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

干预措施: Conventional Balance Exercises Group (Other)

结局指标

主要结局

Berg Balance Test

时间窗: 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

时间窗: 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

时间窗: 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)

时间窗: 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

时间窗: 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

时间窗: 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).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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