Elderly PeopleNCT06375785
Two Different Exercise Methods in Geriatrics
A study testing Otago-based (slow rhythmic) exercise group and LSVT BIG-based (large amplitude) exercise group in people with Elderly People and Nursing Homes, run by Halic University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to compare slow rhythmic exercises with large amplitude exercises in elderly people Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Elderly People, Nursing Homes
- What is being tested?
- Otago-based (slow rhythmic) exercise group and LSVT BIG-based (large amplitude) exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 1 Mar 2024
- 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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Being 65 years or older
- living in a nursing home
- Knowing how to read and write Turkish
- Cognitive functions are sufficient for communication (Standardized Mini Mental Test score over 21 points)
- Being between 1-5 on the Clinical Fragility Scale
- Not taking medical medications regularly due to pain
- Volunteering to participate in the study
Who cannot join
- Having vision and hearing problems that affect communication (except for individuals who communicate with glasses and hearing aids)
- Having a disease that causes neurological, orthopedic and musculoskeletal problems
- Having uncontrolled hypotension/hypertension, cardiovascular problems, metabolic and chronic diseases
- anemic individuals
- Having severe cerebrovascular and peripheral venous insufficiency
- Having had an operation in the last year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Different Exercise Methods in Geriatrics
The aim of the study is to compare slow rhythmic exercises with large amplitude exercises in elderly people
- Conditions
- Elderly People, Nursing Homes
- Being tested
- Otago-based (slow rhythmic) exercise group, LSVT BIG-based (large amplitude) exercise group
- Keywords
- elderly people, LSVT-BIG, Otago, exercise, balance
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Otago-based (slow rhythmic) exercise groupOther
Slow Rhythmic Exercises (Otago based) A.Strength training
- Knee flexion and extension
- Ankle dorsiflexion and plantar flexion
- Toes flexion and extension
- Hip abduction and adduction B. Balance training
- Stepping backwards, walking and turning 2.Side walking 3. Octet walking 4.Tandem walking 5. Standing up from a sitting position
LSVT BIG-based (large amplitude) exercise groupOther
Large Amplitude Exercises (based on LSVT-BIG)
- Bending towards the floor and rising towards the ceiling (opening) while sitting
- While sitting, turn to the right and left with the body and reach out
- Sit down
- Step forward
- Sidestepping
- Stepping back
- Step forward and extend arm towards the ceiling
- Step sideways and extend arm towards the ceiling
- Walking with big steps
- Turning from right to left and left to right while walking
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Otago-based (slow rhythmic) exercise group | Experimental | Not described Receives: Other: Otago-based (slow rhythmic) exercise group |
| Group 2 - LSVT BIG-based (large amplitude) exercise group | Experimental | Not described Receives: Other: LSVT BIG-based (large amplitude) exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up &Go Test
This test is an assessment tool used to predict fall risk in the elderly. It is a test that measures the time between the individual getting up from the chair, walking 3 meters, and turning and sitting again. If the time taken is more than 35 seconds, it is interpreted as an increased risk of falling, while if it is less than 15 seconds, it is interpreted as a decreased risk of falling (Browne et al. 2018).
Measured: At baseline and at week 12
Performanz Balance System
It is an electronic monitoring device designed to analyze lower extremity muscle groups that affect human balance. The basic method used is to reveal the contraction behavior of the muscles by following the balance focus. The device measured the differences between dynamic and static balance, eyes open and eyes closed balance, double leg and single leg (right/left) balance, and right/left foot balance in elderly individuals. During the test, the participant was asked to stand on the balance system and maintain his balance by following the commands given. The platform is linked to computer software that allows the balance to be evaluated objectively. Thanks to this software, measurements were monitored from the researcher's tablet or laptop (Performans Arge ve Yazılım Hizmetleri A.Ş. 2020).
Measured: At baseline and at week 12
Functional Reaching Test
It is an easily applicable dynamic balance measurement technique that has features similar to functional movements. It is a test that can be completed in 5 minutes and evaluates how far the person can reach forward while in a fixed position and their stability during this time, accompanied by an observer. The participant is asked to stand in a stable upright position against a wall (not touching it). The arm is extended against the wall at 90 degrees and the location of the 3rd metacarpal bone is recorded. The participant is asked to lie forward as much as possible without taking a step, and the location of the 3rd metacarpal bone is recorded. The difference between the initial and final localizations of the 3rd metacarpal bone is measured. 3 trials are made and the average of the last two is taken. Distances below 15 cm have been found to be associated with an increased risk of falling (Weiner et al. 1992).
Measured: At baseline and at week 12
Six Minute Walking Test
It is a test used to evaluate an individual's aerobic capacity. Individuals are asked to walk as much as possible for 6 minutes in a corridor that is at least 30 meters long and has a flat and hard surface. The distance traveled in 6 minutes is recorded. While the average walking distance is 570 meters for men aged 50-70 and 540 meters for women; It is stated as 530 meters for men aged 70-80 and 470 meters for women. Test results lower than these values may be associated with a decrease in aerobic capacity (American Thoracic Society 2002).
Measured: At baseline and at week 12
Tinetti Balance and Gait Assessment
This functional test, which is used to determine the risk of falling in the elderly, contains 13 items for balance and 9 items for walking. In the balance test, each item is scored as 0, 1, 2. In the walking test, each item is scored as 0 or 1. A separate score can be calculated for balance and walking, as well as a total score. It is thought that those with scores of 26 and below have problems in terms of balance and walking functions, and it has been stated in studies that those with scores of 19 and below have a fivefold increased risk of falling compared to normal people (Tinetti 1986; Çifçili et al. 2004; Onat et al. 2014).
Measured: At baseline and at week 12
Secondary outcomes (5)
Activity-Specific Balance and Confidence Scale
It was developed by Powell and Myers to evaluate balance confidence at different levels of functions. It consists of 16 tasks related to daily living activities. A high score is associated with high confidence. Turkish validity and reliability study was conducted by Ayhan et al. (Ayhan et al. 2014).
Measured: At baseline and at week 12
Five Times Sit to Stand
In this test, which evaluates the functional strength of the lower extremity, movement transitions, balance and risk of falling, the individual was asked to sit and stand up 5 times as fast as he could, holding his hands across his shoulders. The elapsed time was recorded with a stopwatch (Mong et al. 2010).
Measured: At baseline and at week 12
Montreal Cognitive Assessment Test
It is an assessment scale developed to detect mild cognitive impairment. Cognitive functions evaluated in this test are attention and concentration, executive functions, memory, language, visual structuring skills, abstract thinking, calculation and orientation. It is a short and easy-to-apply scale with an application time of approximately ten minutes. The lowest score that can be obtained from the scale is 0 and the highest score is 30. A total score of 21 or above indicates that the participant is within normal limits. There are various tests used to evaluate cognitive functions in the elderly, and among these tests, the most frequently used scale is a scale that evaluates cognitive functions in different subgroups (Nasreddine et al. 2005). The Turkish validity and reliability study of the test was conducted by Ozdilek et al. (Ozdilek et al. 2014).
Measured: At baseline and at week 12
KATZ Activities of Daily Living Scale
It is one of the most appropriate assessments to evaluate functional status as a measurement of the elderly's ability to perform daily living activities independently. Elders are scored yes/no for independence in each of six functions. A score of 6 indicates full function, 4 indicates moderate impairment, and a score of 2 or less indicates severe functional impairment. The index, baseline measurements taken when the patient is well, is among the most effective scales used among older adults in a variety of care settings, compared to periodic or subsequent measurements (Shelkey et al. 2000). The Turkish validity and reliability study of the scale was conducted by Pehlivanoğlu et al. (Pehlivanoğlu et al. 2018).
Measured: At baseline and at week 12
Clinical Frailty Scale
On a scale that describes the individual from 1 (Very Fit) to 9 (Terminal Illness), each category corresponds to a written description of frailty, complete with a visual chart to aid in the clinical classification of frailty. A score of ≥5 is considered mildly frail. The scale provides predictive information about length of hospital stay and mortality in older people. The validity and reliability study of the scale was conducted by Özsürekci et al.
Measured: At baseline and at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start1 Mar 2023
- Primary completion1 Jun 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly PeopleStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Collaborators
- Fenerbahce University, Istanbul Galata University, Biruni University
- Responsible party
- Principal investigator, Gülsena Utku, Halic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375785
- Sponsor's protocol ID
- LSVT-BIG vs Otago
- Status last verified
- Apr 2024
- First submitted
- 16 Apr 2024
- Last updated
- 23 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Different Exercise Methods in Geriatrics
- ClinicalTrials.gov ID
- NCT06375785
- Acronym / sponsor ID
- LSVT-BIG vs Otago
- Conditions
- Elderly People, Nursing Homes
- Keywords
- elderly people, LSVT-BIG, Otago, exercise, balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Collaborators
- Fenerbahce University, Istanbul Galata University, Biruni University
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 19 Apr 2024 (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 aim of the study is to compare slow rhythmic exercises with large amplitude exercises in elderly people
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Otago-based (slow rhythmic) exercise group | Experimental | Other: Otago-based (slow rhythmic) exercise group |
| Group 2 - LSVT BIG-based (large amplitude) exercise group | Experimental | Other: LSVT BIG-based (large amplitude) exercise group |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Being 65 years or older
- living in a nursing home
- Knowing how to read and write Turkish
- Cognitive functions are sufficient for communication (Standardized Mini Mental Test score over 21 points)
- Being between 1-5 on the Clinical Fragility Scale
Key exclusion criteria (6 listed)
- Having vision and hearing problems that affect communication (except for individuals who communicate with glasses and hearing aids)
- Having a disease that causes neurological, orthopedic and musculoskeletal problems
- Having uncontrolled hypotension/hypertension, cardiovascular problems, metabolic and chronic diseases
- anemic individuals
- Having severe cerebrovascular and peripheral venous insufficiency
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 |
|---|---|---|
| Otago-based (slow rhythmic) exercise groupSlow Rhythmic Exercises (Otago based) A.Strength training 1. Knee flexion and extension 2. Ankle dorsiflexion and plantar flexion 3. Toes flexion and extension 4. Hip abduction and adduction B. Balance training 1. Stepping backwards, walking and turning 2.Side walking 3. Octet walking 4.Tandem walking 5. Standing up from a sitting position | Other | Group 1 - Otago-based (slow rhythmic) exercise group |
| LSVT BIG-based (large amplitude) exercise groupLarge Amplitude Exercises (based on LSVT-BIG) 1. Bending towards the floor and rising towards the ceiling (opening) while sitting 2. While sitting, turn to the right and left with the body and reach out 3. Sit down 4. Step forward 5. Sidestepping 6. Stepping back 7. Step forward and extend arm towards the ceiling 8. Step sideways and extend arm towards the ceiling 9. Walking with big steps 10. Turning from right to left and left to right while walking | Other | Group 2 - LSVT BIG-based (large amplitude) exercise group |
Primary outcome
Timed Up &Go Test
Time frame: At baseline and at week 12
This test is an assessment tool used to predict fall risk in the elderly. It is a test that measures the time between the individual getting up from the chair, walking 3 meters, and turning and sitting again. If the time taken is more than 35 seconds, it is interpreted as an increased risk of falling, while if it is less than 15 seconds, it is interpreted as a decreased risk of falling (Browne et al. 2018).
Performanz Balance System
Time frame: At baseline and at week 12
It is an electronic monitoring device designed to analyze lower extremity muscle groups that affect human balance. The basic method used is to reveal the contraction behavior of the muscles by following the balance focus. The device measured the differences between dynamic and static balance, eyes open and eyes closed balance, double leg and single leg (right/left) balance, and right/left foot balance in elderly individuals. During the test, the participant was asked to stand on the balance system and maintain his balance by following the commands given. The platform is linked to computer software that allows the balance to be evaluated objectively. Thanks to this software, measurements were monitored from the researcher's tablet or laptop (Performans Arge ve Yazılım Hizmetleri A.Ş. 2020).
Functional Reaching Test
Time frame: At baseline and at week 12
It is an easily applicable dynamic balance measurement technique that has features similar to functional movements. It is a test that can be completed in 5 minutes and evaluates how far the person can reach forward while in a fixed position and their stability during this time, accompanied by an observer. The participant is asked to stand in a stable upright position against a wall (not touching it). The arm is extended against the wall at 90 degrees and the location of the 3rd metacarpal bone is recorded. The participant is asked to lie forward as much as possible without taking a step, and the location of the 3rd metacarpal bone is recorded. The difference between the initial and final localizations of the 3rd metacarpal bone is measured. 3 trials are made and the average of the last two is taken. Distances below 15 cm have been found to be associated with an increased risk of falling (Weiner et al. 1992).
Six Minute Walking Test
Time frame: At baseline and at week 12
It is a test used to evaluate an individual's aerobic capacity. Individuals are asked to walk as much as possible for 6 minutes in a corridor that is at least 30 meters long and has a flat and hard surface. The distance traveled in 6 minutes is recorded. While the average walking distance is 570 meters for men aged 50-70 and 540 meters for women; It is stated as 530 meters for men aged 70-80 and 470 meters for women. Test results lower than these values may be associated with a decrease in aerobic capacity (American Thoracic Society 2002).
Tinetti Balance and Gait Assessment
Time frame: At baseline and at week 12
This functional test, which is used to determine the risk of falling in the elderly, contains 13 items for balance and 9 items for walking. In the balance test, each item is scored as 0, 1, 2. In the walking test, each item is scored as 0 or 1. A separate score can be calculated for balance and walking, as well as a total score. It is thought that those with scores of 26 and below have problems in terms of balance and walking functions, and it has been stated in studies that those with scores of 19 and below have a fivefold increased risk of falling compared to normal people (Tinetti 1986; Çifçili et al. 2004; Onat et al. 2014).
5 secondary outcomes
Activity-Specific Balance and Confidence Scale
Time frame: At baseline and at week 12
Five Times Sit to Stand
Time frame: At baseline and at week 12
Montreal Cognitive Assessment Test
Time frame: At baseline and at week 12
KATZ Activities of Daily Living Scale
Time frame: At baseline and at week 12
Clinical Frailty Scale
Time frame: At baseline and at week 12
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 23 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Otago-based (slow rhythmic) exercise group and LSVT BIG-based (large amplitude) exercise group in people with Elderly People and Nursing Homes, run by Halic 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 7 inclusion and 6 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 23 Apr 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 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?
Timed Up &Go Test (time frame: At baseline and at week 12). 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 23 Apr 2024.