Elderly PopulationNCT04293952
Comparison of (Balance, Resistance, Aerobic and Cognitive Exercises) & (Balance Resistance Exercise)
A study testing Balance, Resistance, Aerobic, Cognition Exercises (BRACE) and Balance Resistance Exercise (BRE) in people with Elderly Population, run by Riphah International University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elderly Population
- What is being tested?
- Balance, Resistance, Aerobic, Cognition Exercises (BRACE) and Balance Resistance Exercise (BRE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2020to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Berg balance score 20-40
- Mini-mental state examination not less than 23
Who cannot join
- Musculoskeletal conditions (fractures, severe arthritis grade iii and iv)
- Neurological conditions like Epilepsy, Parkinson,
- Alzheimer's, Impaired cognition
- Other systemic diseases or co-morbidities
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54000
About this study
Official title: Comparison of BRACE(Balance, Resistance, Aerobic, and Cognitive Exercises) and BRE (Balance Resistance Exercises) on Fall Risk Reduction in Elderly
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.
Read the 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
- Being tested
- Balance, Resistance, Aerobic, Cognition Exercises (BRACE), Balance Resistance Exercise (BRE)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance, Resistance, Aerobic, Cognition Exercises (BRACE)Other
BRACE is a combination of different exercises including Balance, Resistance, Aerobic, Cognition for fall risk reduction and to mobility in the elderly.
Balance Resistance Exercise (BRE)Other
this is the simple conventional treatment for the elderly in balance problems including warm-up, resistance exercises and cool-down exercises.
| Study group | Role | What they receive |
|---|---|---|
| BRACE group | Experimental | BRACE include combination of exercises including, Balance, Resistance, Aerobic, Cognition Exercises. Receives: Other: Balance, Resistance, Aerobic, Cognition Exercises (BRACE) |
| BRE group | Active comparator | 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 Receives: Other: Balance Resistance Exercise (BRE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
changes from the baseline, Berg balance scale (BBS) is used for assessment of balance and fall risk, Higher scores on the BBS indicate greater independence and better ability to balance. In contrast, lower scores indicate a greater fall risk Items DESCRIPTION SCORE (0-4) Sitting to standing, Standing unsupported, Sitting unsupported, Standing to sitting, Transfers , Standing with eyes closed , Standing with feet together, Reaching forward with outstretched arm, Retrieving object from floor, Turning to look behind, Turning 360 degrees, Placing alternate foot on stool, Standing with one foot in front, Standing on one foot, TOTAL __/56
Measured: week 9
timed up and go test (TUG)
changes from the baseline, Timed up and go test is used for the assessment of falls risk among the elderly population. The Timed "Up and Go" (TUG) Test measures, in seconds, the time is taken by an individual to stand up from a standard armchair (approximate seat height of 46 cm, arm height 65 cm), walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair, and sit down. Normal healthy elderly usually complete the task in 10 seconds or less. Very frail or weak elderly with poor mobility may take 2 minutes or more. Clinical guide: <10 seconds = normal <20 seconds = good mobility, can go out alone, mobile without a gait aid <30 seconds = problems, cannot go outside alone, requires a gait aid A score of more than or equal to 14 seconds has been shown to indicate a high risk of falls.
Measured: week 9
6 minute walk test
The object of this test is to walk as far as possible for 6 minutes. the patient will walk back and forth in this hallway. Six minutes is a long time to walk, so the patient will be exerting. he will probably get out of breath or become exhausted. patients are permitted to slow down, to stop, and to rest as necessary. he may lean against the wall while resting, but resume walking as soon as patients are able. the patient will be walking back and forth around the cones. the patient should pivot briskly around the cones and continue back the other way without hesitation Predictive equation for males: 6 Minute Walk Distance (m) = 867 - (5.71 age, yrs) + (1.03 height, cm) Predictive equation for females: 6 Minute Walk Distance(m) = 525 - (2.86 age, yrs) + (2.71 height, cm) - (6.22 BMI).
Measured: week 9
Secondary outcomes (1)
Mini mental state examination
The Mini-Mental State Exam (MMSE) is a widely used test of cognitive function among the elderly; it includes tests of orientation, attention, memory, language and visual-spatial skills. Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start1 Jul 2020
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Elderly PopulationStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arshad Nawaz Malik, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293952
- Sponsor's protocol ID
- REC/Lhr/20/2010 Ayesha Batool
- Status last verified
- Mar 2021
- First submitted
- 1 Mar 2020
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25142277Afridi 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.
PubMed 29540893Prata 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.
PubMed 26592222Zhuang 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.
PubMed 24453483
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of BRACE(Balance, Resistance, Aerobic, and Cognitive Exercises) and BRE (Balance Resistance Exercises) on Fall Risk Reduction in Elderly
- ClinicalTrials.gov ID
- NCT04293952
- Acronym / sponsor ID
- REC/Lhr/20/2010 Ayesha Batool
- Conditions
- Elderly Population
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BRACE group | Experimental | Other: Balance, Resistance, Aerobic, Cognition Exercises (BRACE)BRACE include combination of exercises including, Balance, Resistance, Aerobic, Cognition Exercises. |
| BRE group | Active comparator | Other: Balance Resistance Exercise (BRE)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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Berg balance score 20-40
- Mini-mental state examination not less than 23
Key exclusion criteria (4 listed)
- Musculoskeletal conditions (fractures, severe arthritis grade iii and iv)
- Neurological conditions like Epilepsy, Parkinson,
- Alzheimer's, Impaired cognition
- Other systemic diseases or co-morbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | BRACE group |
| 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. | Other | BRE group |
Primary outcome
Berg Balance Scale
Time frame: week 9
changes from the baseline, Berg balance scale (BBS) is used for assessment of balance and fall risk, Higher scores on the BBS indicate greater independence and better ability to balance. In contrast, lower scores indicate a greater fall risk Items DESCRIPTION SCORE (0-4) Sitting to standing, Standing unsupported, Sitting unsupported, Standing to sitting, Transfers , Standing with eyes closed , Standing with feet together, Reaching forward with outstretched arm, Retrieving object from floor, Turning to look behind, Turning 360 degrees, Placing alternate foot on stool, Standing with one foot in front, Standing on one foot, TOTAL __/56
timed up and go test (TUG)
Time frame: week 9
changes from the baseline, Timed up and go test is used for the assessment of falls risk among the elderly population. The Timed "Up and Go" (TUG) Test measures, in seconds, the time is taken by an individual to stand up from a standard armchair (approximate seat height of 46 cm, arm height 65 cm), walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair, and sit down. Normal healthy elderly usually complete the task in 10 seconds or less. Very frail or weak elderly with poor mobility may take 2 minutes or more. Clinical guide: <10 seconds = normal <20 seconds = good mobility, can go out alone, mobile without a gait aid <30 seconds = problems, cannot go outside alone, requires a gait aid A score of more than or equal to 14 seconds has been shown to indicate a high risk of falls.
6 minute walk test
Time frame: week 9
The object of this test is to walk as far as possible for 6 minutes. the patient will walk back and forth in this hallway. Six minutes is a long time to walk, so the patient will be exerting. he will probably get out of breath or become exhausted. patients are permitted to slow down, to stop, and to rest as necessary. he may lean against the wall while resting, but resume walking as soon as patients are able. the patient will be walking back and forth around the cones. the patient should pivot briskly around the cones and continue back the other way without hesitation Predictive equation for males: 6 Minute Walk Distance (m) = 867 - (5.71 age, yrs) + (1.03 height, cm) Predictive equation for females: 6 Minute Walk Distance(m) = 525 - (2.86 age, yrs) + (2.71 height, cm) - (6.22 BMI).
1 secondary outcome
Mini mental state examination
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Background: PubMed 25142277Halvarsson 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.
- Background: PubMed 29540893Afridi 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.
- Background: PubMed 26592222Prata 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.
- Background: PubMed 24453483Zhuang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arshad Nawaz Malik, PhD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance, Resistance, Aerobic, Cognition Exercises (BRACE) and Balance Resistance Exercise (BRE) in people with Elderly Population, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (time frame: week 9). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04293952, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2021.