Fall PatientsNCT05340387
Effects of BRACE Protocol on Fall Risk Among Elderly Population
A study testing Balance Resistance Aerobic Cognitive exercises (BRACE) and Otago's Protocol in people with Fall Patients, run by Riphah International University at 1 site in Pakistan.
Trial summary
The objective of this study is to compare the effects of Balance Resistance Aerobic Cognitive Exercises (BRACE) and Otago's exercises on fall risk among elderly population. And to determine the effects of BRACE and Otago's exercise on static and Dynamic balance in elderly population. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Fall Patients
- What is being tested?
- Balance Resistance Aerobic Cognitive exercises (BRACE) and Otago's Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Apr 2022to 30 Jun 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- berg and balance 0-39
- MOCA score not less than 22
Who cannot join
- • Severe cognitive impairment that prevented them from understanding instructions.
- Serious musculoskeletal, neurological and visual impairment that might affect measurement.
- Involvement in other exercise programs.
- Patients have vertebrobasilar insufficiency
- Atlanto-axial instability
- Osteoporosis
- Rheumatoid arthritis
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Helping Hand Institute of rehabilitation
Mānsehra, Khyber Pakhtunkhuwa, 2500
About this study
Official title: Comparison of Balance Resistance Aerobic Cognitive Exercises (BRACE) and Otago's Exercises on Fall Risk Among Elderly Population
The objective of this study is to compare the effects of Balance Resistance Aerobic Cognitive Exercises (BRACE) and Otago's exercises on fall risk among elderly population. And to determine the effects of BRACE and Otago's exercise on static and Dynamic balance in elderly population. the study will be randomized control trial including experimental and control group with estimated 17 individual in each group. Balance resistance aerobic resistance exercises will be performed by experimental group and Otago's protocol will be performed by control group.
Read the detailed description
Balance control is the foundation of a person's ability to move and function independently. However, balance control declines with age, and impaired balance is a major risk factor for falls among older adults. Training balance during dual-task conditions appears to be necessary to improve balance control under situations with divided attention.
Balance training program for older adults, including dual- and multi-task exercises, was designed and developed based on well-established principles of exercise and on the knowledge that balance control relies on the interaction of several physiological systems, as well as interaction with environmental factors and the performed task.
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.
A new tool has been designed for fall risk reduction and to mobility in elderly is BRACE (Balance, Resistance, Aerobic, Cognition Exercises). Limited work was done on BRACE protocol so in this study we will do further work on this innovative protocol. The aim of our study is to compare the effects of Balance Resistance Aerobic Cognitive Exercises (BRACE) and Otago's exercises on mobility and fall risk reduction in the elderly
- Conditions
- Fall Patients
- Being tested
- Balance Resistance Aerobic Cognitive exercises (BRACE), Otago's Protocol
- Keywords
- BRACE Protocol, Otago's Protocol, Fall Risk, Elderly Population
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance Resistance Aerobic Cognitive exercises (BRACE)Other
Study will be conducted after the approval of Ethical review board. The BRACE exercise training would be perform in 4 times a week for 12 weeks, lasting approximately 40-50 minutes each time. Week 1-3 : Balance: Romberg, tandom standing, single leg stance Resistance: chair rise Aerobic exercises: 6mint walk Cognitive: count reverse from 50 Week 4-6: Balance: Sit to stand, functional reach, Tug Test Resistance: stair climbing Aerobic Exercises: Marching in space Cognitive: Remember 5 words, spell backward, remember 5 animals Week 7-9: Balance: Perturbation, throwing a ball, kicking a ball Resistance: Floor transfer, squatting Aerobic Exercises: Cycling Cognitive: Count even number from 1-50, calculation, addition, subtraction, multiplication division Week 10-12: Balance: Combination of All Resistance: Combination of All Aerobic Exercises: 6 minutes' walk test, marching steps, cycling Cognitive: Combination of all
Otago's ProtocolOther
Study will be conducted after the approval of Ethical review board. The Otago's exercise training would be perform in 4 times a week for 12 weeks, lasting approximately 40-50 minutes each time. WEEK 1-3: Warm up: March, head movement, neck movement, back extension, trunk movement, ankle movements Strength: Front knee strengthening, Back knee strengthening, Side hip strengthening, Calf raises, Toe raises (10 repetitions each) Balance: Knee bends, Backwards walking, Walking and turning around, Sideways walking, Tandem stance (heel toe stand), Tandem walk (heel toe walk), One leg stand, Heel walking, Toe walk, Heel toe walking backwards, Sit to stand, Stair walking. (10 repetitions each) Flexibility: calf stretch, back of thigh stretch Hold for 10 to 15 seconds and repeat on other leg.
Walk: 5 or 10 minutes' walk
This protocol will be followed for 12 weeks with increased repetitions after every 3 week.
| Study group | Role | What they receive |
|---|---|---|
| Balance Resistance Aerobic Cognitive Exercises (BRACE) | Experimental | BRACE include combination of exercises including, Balance, Resistance, Aerobic, Cognition Exercises. Receives: Other: Balance Resistance Aerobic Cognitive exercises (BRACE) |
| Otago's Exercises | Active comparator | Otago's protocol is combination of warm up, strengthening, balance and flexibility exercises. Receives: Other: Otago's Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg And 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: 12 weeks
Time Up And Go
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: 12 week
MOCA
The Montreal Cognitive Assessment (MOCA) is a cognitive screening instrument developed to detect mild cognitive impairment (MCI). It is a simple 10 min paper and pencil test that assesses multiple cognitive domains including memory, language, executive functions, visuo-patial skills, calculation, abstraction, attention, concentration, and orientation.
Scores on the MoCA range from zero to 30. A score of 26 and higher is considered normal.
In the initial study data, normal controls had an average score of 27.4. People with mild cognitive impairment (MCI) scored an average of 22.1. People with Alzheimer's disease had an average score of 16.2.
Measured: 12 weeks
Gait dynamic index
The DGI tests the ability of the participant to maintain walking balance while responding to different task demands, through various dynamic conditions.
It includes eight items, walking on level surfaces, changing speeds, head turns in horizontal and vertical directions, walking and turning 180 degrees to stop, stepping over and around obstacles, and stair ascent and descent.
Each item is scored on a scale of 0 to 3, with 3 indicating normal performance and 0 representing severe impairment. The best possible score on the DGI is a 24.
Measured: 12 weeks
Activity specific balance scale
Activities-specific balance confidence (ABC) scale is a structured questionnaire that measures an individual's confidence during ambulatory activities without falling or experiencing a sense of unsteadiness. It's a 16-item questionnaire where patients' rate their confidence while doing activities. Scoring from 0-100 (0 is no confidence and 100 is full confidence).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start5 Apr 2022
- Primary completion15 May 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall PatientsStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadia Azhar, MS-NMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340387
- Sponsor's protocol ID
- Ghulam Qadir
- Status last verified
- Jun 2024
- First submitted
- 15 Apr 2022
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Balance Resistance Aerobic Cognitive Exercises (BRACE) and Otago's Exercises on Fall Risk Among Elderly Population
- ClinicalTrials.gov ID
- NCT05340387
- Acronym / sponsor ID
- Ghulam Qadir
- Conditions
- Fall Patients
- Keywords
- BRACE Protocol, Otago's Protocol, Fall Risk, Elderly Population
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 22 Apr 2022 (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.
The objective of this study is to compare the effects of Balance Resistance Aerobic Cognitive Exercises (BRACE) and Otago's exercises on fall risk among elderly population. And to determine the effects of BRACE and Otago's exercise on static and Dynamic balance in elderly population. the study will be randomized control trial including experimental and control group with estimated 17 individual in each group. Balance resistance aerobic resistance exercises will be performed by experimental group and Otago's protocol will be performed by control group.
Detailed description
Balance control is the foundation of a person's ability to move and function independently. However, balance control declines with age, and impaired balance is a major risk factor for falls among older adults. Training balance during dual-task conditions appears to be necessary to improve balance control under situations with divided attention.
Balance training program for older adults, including dual- and multi-task exercises, was designed and developed based on well-established principles of exercise and on the knowledge that balance control relies on the interaction of several physiological systems, as well as interaction with environmental factors and the performed task.
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.
A new tool has been designed for fall risk reduction and to mobility in elderly is BRACE (Balance, Resistance, Aerobic, Cognition Exercises). Limited work was done on BRACE protocol so in this study we will do further work on this innovative protocol. The aim of our study is to compare the effects of Balance Resistance Aerobic Cognitive Exercises (BRACE) and Otago's exercises on mobility and fall risk reduction in the elderly
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balance Resistance Aerobic Cognitive Exercises (BRACE) | Experimental | Other: Balance Resistance Aerobic Cognitive exercises (BRACE)BRACE include combination of exercises including, Balance, Resistance, Aerobic, Cognition Exercises. |
| Otago's Exercises | Active comparator | Other: Otago's ProtocolOtago's protocol is combination of warm up, strengthening, balance and flexibility exercises. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- berg and balance 0-39
- MOCA score not less than 22
Key exclusion criteria (7 listed)
- • Severe cognitive impairment that prevented them from understanding instructions.
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 Cognitive exercises (BRACE)Study will be conducted after the approval of Ethical review board. The BRACE exercise training would be perform in 4 times a week for 12 weeks, lasting approximately 40-50 minutes each time. Week 1-3 : Balance: Romberg, tandom standing, single leg stance Resistance: chair rise Aerobic exercises: 6mint walk Cognitive: count reverse from 50 Week 4-6: Balance: Sit to stand, functional reach, Tug Test Resistance: stair climbing Aerobic Exercises: Marching in space Cognitive: Remember 5 words, spell backward, remember 5 animals Week 7-9: Balance: Perturbation, throwing a ball, kicking a ball Resistance: Floor transfer, squatting Aerobic Exercises: Cycling Cognitive: Count even number from 1-50, calculation, addition, subtraction, multiplication division Week 10-12: Balance: Combination of All Resistance: Combination of All Aerobic Exercises: 6 minutes' walk test, marching steps, cycling Cognitive: Combination of all | Other | Balance Resistance Aerobic Cognitive Exercises (BRACE) |
| Otago's ProtocolStudy will be conducted after the approval of Ethical review board. The Otago's exercise training would be perform in 4 times a week for 12 weeks, lasting approximately 40-50 minutes each time. WEEK 1-3: Warm up: March, head movement, neck movement, back extension, trunk movement, ankle movements Strength: Front knee strengthening, Back knee strengthening, Side hip strengthening, Calf raises, Toe raises (10 repetitions each) Balance: Knee bends, Backwards walking, Walking and turning around, Sideways walking, Tandem stance (heel toe stand), Tandem walk (heel toe walk), One leg stand, Heel walking, Toe walk, Heel toe walking backwards, Sit to stand, Stair walking. (10 repetitions each) Flexibility: calf stretch, back of thigh stretch Hold for 10 to 15 seconds and repeat on other leg. Walk: 5 or 10 minutes' walk This protocol will be followed for 12 weeks with increased repetitions after every 3 week. | Other | Otago's Exercises |
Primary outcome
Berg And Balance scale
Time frame: 12 weeks
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
Time Up And Go
Time frame: 12 week
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.
MOCA
Time frame: 12 weeks
The Montreal Cognitive Assessment (MOCA) is a cognitive screening instrument developed to detect mild cognitive impairment (MCI). It is a simple 10 min paper and pencil test that assesses multiple cognitive domains including memory, language, executive functions, visuo-patial skills, calculation, abstraction, attention, concentration, and orientation. Scores on the MoCA range from zero to 30. A score of 26 and higher is considered normal. In the initial study data, normal controls had an average score of 27.4. People with mild cognitive impairment (MCI) scored an average of 22.1. People with Alzheimer's disease had an average score of 16.2.
Gait dynamic index
Time frame: 12 weeks
The DGI tests the ability of the participant to maintain walking balance while responding to different task demands, through various dynamic conditions. It includes eight items, walking on level surfaces, changing speeds, head turns in horizontal and vertical directions, walking and turning 180 degrees to stop, stepping over and around obstacles, and stair ascent and descent. Each item is scored on a scale of 0 to 3, with 3 indicating normal performance and 0 representing severe impairment. The best possible score on the DGI is a 24.
Activity specific balance scale
Time frame: 12 weeks
Activities-specific balance confidence (ABC) scale is a structured questionnaire that measures an individual's confidence during ambulatory activities without falling or experiencing a sense of unsteadiness. It's a 16-item questionnaire where patients' rate their confidence while doing activities. Scoring from 0-100 (0 is no confidence and 100 is full confidence).
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 7 Jun 2024.
- 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.
Nadia Azhar, MS-NMPT 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 Cognitive exercises (BRACE) and Otago's Protocol in people with Fall Patients, 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 7 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 7 Jun 2024. 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 And Balance scale (time frame: 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jun 2024.