Frail Elderly SyndromeNCT04615533
Validity Reliability of FrailBESTest in Older Adults
An observational study of Frail Elderly Syndrome and Balance; Distorted, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
Fraility; It is an age-related biological syndrome. It is characterized by decreased resistance to stressors due to changes in functional reserves and physiological systems. BESTest, which is frequently used in the literature, was modified and Frail'BESTest was developed to detect balance problems in fragile… Read more about this study
- Who is it for?
- Ages 65 to 95 years
- Conditions the study is for
- Frail Elderly Syndrome, Balance; Distorted, Assessment, Self
- What is being tested?
- Frail older adults, assessment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Oct 2020to 1 Jan 2022
- Phase
- Observational
- 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 65 to 95 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Individuals aged 65 and over, Volunteering to participate in research, No cooperation and communication problem
Who may be able to join
- Individuals aged 65 and over,
- Your willingness to participate in research Elderly individuals with a diagnosis of frailty
- No cooperation and communication problems
Who cannot join
- Individuals with neurological and orthopedic problems Uncontrollable hypertension
- Those with cardiac disease
- Those with cooperation and communication problems
Trial locations and contacts
1 site in 1 country.
About this study
Fraility; It is an age-related biological syndrome. It is characterized by decreased resistance to stressors due to changes in functional reserves and physiological systems.
BESTest, which is frequently used in the literature, was modified and Frail'BESTest was developed to detect balance problems in fragile individuals. The test consists of 6 subtitles. These are participation, reaction, movement ability, sensory organization, biomechanical constraints, gait symmetry. When looking at the literature, the Turkish version of Frail'BESTest has not been found. For this reason, the aim of study is to examine the validity and reliability of the Turkish version of Frail'BESTest in elderly individuals and to question the effectiveness of its clinical use and to bring it to the use of other researchers.
Read the detailed description
Fraility; It is an age-related biological syndrome. It is characterized by decreased resistance to stressors due to changes in functional reserves and physiological systems.Especially, the increase in the incidence of falls, loss of mobility, dependence in basic life activities, increase in hospitalizations and increased incidence of death make the diagnosis and treatment of frailty important in elderly individuals.
BESTest, which is frequently used in the literature, was modified and Frail'BESTest was developed to detect balance problems in fragile individuals. The test consists of 6 subtitles. These are participation, reaction, movement ability, sensory organization, biomechanical constraints, gait symmetry. When looking at the literature, the Turkish version of Frail'BESTest has not been found. For this reason, the aim of study is to examine the validity and reliability of the Turkish version of Frail'BESTest in elderly individuals and to question the effectiveness of its clinical use and to bring it to the use of other researchers.
- Conditions
- Frail Elderly Syndrome, Balance; Distorted, Assessment, Self
- Being tested
- Frail older adults, assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frail older adults, assessmentOther
Frail'BESTest, Clinical Frailty Scale, Mini BESTest, Berg Balance Scale, Tinnetti Balance and gait sacale
| Study group | Role | What they receive |
|---|---|---|
| Frail older adults, assessment | Frail older adults, assessment Frail'BESTest, Clinical Frailty Scale, Mini BESTest, Berg Balance Scale, Tinetti Blance and Gait Scale Receives: Other: Frail older adults, assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frail'BESTest
The test consists of 6 subtitles. These are participation, reaction, movement ability, sensory organization, biomechanical constraints, gait symmetry.
Measured: Day 1
Clinical Frailty Scale
Scale evaluates physical weaknesses such as comorbidity, cognitive impairment, and disability. Scale scoring is from 1 (very favorable) to 9 (terminally ill)
Measured: Day 1
Mini BESTest
The Mini-BESTest consists of 14 items and evaluates 4 different components of dynamic balance (1) antispatient postural adjustments, (2) reactive postural control, (3) sensory orientation and (4) dynamic walking).
Measured: Day 1
Berg Balance Test
The BBS consists of 14 items to directly monitor the maintenance of body balance during performance
Measured: Day 1
Tinetti Balance and Gait Test
In the test used to evaluate balance, walking score is maximum 12 points, balance score is maximum 16 points and a total of 28 points
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 posted4 Nov 2020
- Study start25 Oct 2020
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frail Elderly SyndromeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Abit Kocaman, Kırıkkale University
- Investigators
- Ayşe Abit Kocaman, Principal investigator, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615533
- Sponsor's protocol ID
- Frail'BESTest
- Status last verified
- Jan 2022
- First submitted
- 29 Oct 2020
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kubicki A, Brika M, Coquisart L, Basile G, Laroche D, Mourey F. The Frail'BESTest. An Adaptation of the "Balance Evaluation System Test" for Frail Older Adults. Description, Internal Consistency and Inter-Rater Reliability. Clin Interv Aging. 2020 Jul 30;15:1249-1262. doi: 10.2147/CIA.S247332. eCollection 2020.
PubMed 32801673
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity Reliability of FrailBESTest in Older Adults
- ClinicalTrials.gov ID
- NCT04615533
- Acronym / sponsor ID
- Frail'BESTest
- Conditions
- Frail Elderly Syndrome, Balance; Distorted, Assessment, Self
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 25 Oct 2020 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 4 Nov 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.
Fraility; It is an age-related biological syndrome. It is characterized by decreased resistance to stressors due to changes in functional reserves and physiological systems.
BESTest, which is frequently used in the literature, was modified and Frail'BESTest was developed to detect balance problems in fragile individuals. The test consists of 6 subtitles. These are participation, reaction, movement ability, sensory organization, biomechanical constraints, gait symmetry. When looking at the literature, the Turkish version of Frail'BESTest has not been found. For this reason, the aim of study is to examine the validity and reliability of the Turkish version of Frail'BESTest in elderly individuals and to question the effectiveness of its clinical use and to bring it to the use of other researchers.
Detailed description
Fraility; It is an age-related biological syndrome. It is characterized by decreased resistance to stressors due to changes in functional reserves and physiological systems.Especially, the increase in the incidence of falls, loss of mobility, dependence in basic life activities, increase in hospitalizations and increased incidence of death make the diagnosis and treatment of frailty important in elderly individuals.
BESTest, which is frequently used in the literature, was modified and Frail'BESTest was developed to detect balance problems in fragile individuals. The test consists of 6 subtitles. These are participation, reaction, movement ability, sensory organization, biomechanical constraints, gait symmetry. When looking at the literature, the Turkish version of Frail'BESTest has not been found. For this reason, the aim of study is to examine the validity and reliability of the Turkish version of Frail'BESTest in elderly individuals and to question the effectiveness of its clinical use and to bring it to the use of other researchers.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Frail older adults, assessment | – | Other: Frail older adults, assessmentFrail older adults, assessment Frail'BESTest, Clinical Frailty Scale, Mini BESTest, Berg Balance Scale, Tinetti Blance and Gait Scale |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Individuals aged 65 and over, Volunteering to participate in research, No cooperation and communication problem
Key inclusion criteria (3 listed)
- Individuals aged 65 and over,
Key exclusion criteria (3 listed)
- Individuals with neurological and orthopedic problems Uncontrollable hypertension
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 |
|---|---|---|
| Frail older adults, assessmentFrail'BESTest, Clinical Frailty Scale, Mini BESTest, Berg Balance Scale, Tinnetti Balance and gait sacale | Other | Frail older adults, assessment |
Primary outcome
Frail'BESTest
Time frame: Day 1
The test consists of 6 subtitles. These are participation, reaction, movement ability, sensory organization, biomechanical constraints, gait symmetry.
Clinical Frailty Scale
Time frame: Day 1
Scale evaluates physical weaknesses such as comorbidity, cognitive impairment, and disability. Scale scoring is from 1 (very favorable) to 9 (terminally ill)
Mini BESTest
Time frame: Day 1
The Mini-BESTest consists of 14 items and evaluates 4 different components of dynamic balance (1) antispatient postural adjustments, (2) reactive postural control, (3) sensory orientation and (4) dynamic walking).
Berg Balance Test
Time frame: Day 1
The BBS consists of 14 items to directly monitor the maintenance of body balance during performance
Tinetti Balance and Gait Test
Time frame: Day 1
In the test used to evaluate balance, walking score is maximum 12 points, balance score is maximum 16 points and a total of 28 points
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 21 Jan 2022.
- Background: PubMed 32801673Kubicki A, Brika M, Coquisart L, Basile G, Laroche D, Mourey F. The Frail'BESTest. An Adaptation of the "Balance Evaluation System Test" for Frail Older Adults. Description, Internal Consistency and Inter-Rater Reliability. Clin Interv Aging. 2020 Jul 30;15:1249-1262. doi: 10.2147/CIA.S247332. eCollection 2020.
- 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.
Ayşe Abit Kocaman principal investigator
Kırıkkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frail Elderly Syndrome and Balance; Distorted, run by Kırıkkale University at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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 21 Jan 2022. 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 Turkey (Türkiye). 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?
Frail'BESTest (time frame: Day 1). 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?
On the ClinicalTrials.gov record for NCT04615533, which also lists 1 linked publication.
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 21 Jan 2022.