Fall RiskFallRiskNCT06891014
Effects of Regular Exercise on Sensory-motor Functions and Fall Risk in the Elderly
A study testing Combine Exercise in people with Fall Risk and Exercise, run by Cyprus International University at 1 site in Turkey (Türkiye).
Trial summary
Falls in elderly population are an important public health problem. The aim of this study is to examine the vibration, proprioception, muscle strength, static balance, reaction time and postural stability parameters of female individuals aged 65 and over who exercise regularly by comparing them with sedentary female… Read more about this study
- Who is it for?
- Ages 65 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fall Risk, Exercise, Functional Outcomes
- What is being tested?
- Combine Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Feb 2024to 22 May 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 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Sedentary individuals with an International Physical Activity Questionnaire (IPAQ) score of <600 (for control group)
- Individuals who will be participated in an eight-week regular exercise program (for the exercise group)
- Those who scored 24 or higher on the standardized Mini-Mental State Examination, individuals without communication problems, and those who were not bedridden or wheelchair-bound.
Who cannot join
- Individuals who had received any diagnosis/treatment for spinal or lower extremity problems or had undergone surgery within the last six months, as well as those with severe chronic illnesses or uncontrolled conditions (e.g., hypertension, cancer), will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cyprus International University
Mersin, Haspolat
About this study
Falls in elderly population are an important public health problem. The aim of this study is to examine the vibration, proprioception, muscle strength, static balance, reaction time and postural stability parameters of female individuals aged 65 and over who exercise regularly by comparing them with sedentary female individuals in the same age group and to determine the effect rates of these parameters on fall risk. A total of 92 individuals will evaluate in the study, including 46 participants who perform regular exercise and 46 participants with a sedentary lifestyle. Participants who performs regular exercise will determine among individuals who going to participate in a combined exercise program under the control of a physiotherapist, 2-3 days a week for 8 weeks. The socio-demographic characteristics, health conditions and exercise habits of the participants will be recorded. For evaluating the physical activity levels of the participants, the International Physical Activity Questionnaire-short form (IPAQ-SF); for vibration sense evaluation, 128-Hz frequency tuning fork; for the evaluation of proprioception sense, angle repetition test; for the isometric muscle strength assessment, digital hand dynamometer; for static balance evaluation, standing stork balance test; for reaction time evaluation, MoART measuring device; for postural stability evaluation, PROKIN-PK200W* (Tecnobody, Italy) device and for fall risk assessment, Morse fall scale and MAHC-10 fall questionnaire will be used.
- Conditions
- Fall Risk, Exercise, Functional Outcomes, Aging
- Being tested
- Combine Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combine ExerciseOther
Also called Exercise
The participants in the exercise group will be individuals over the age of 65 who applied the same exercise programs 2-3 days a week for 8 weeks under the control of two different physiotherapists independent of the study. The exercise session will be applied for one hour, including a warm-up phase, a combined exercise program including strengthening, stretching, balance and proprioceptive exercises, and a cool-down phase.
| Study group | Role | What they receive |
|---|---|---|
| Combine Exercise Group | Active comparator | Participants who will participate in a combine exercise program under the control of a physiotherapist, 2-3 days a week for 8 weeks. Receives: Other: Combine Exercise |
| Control Group | No intervention | Control Group with a sedentary lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fall Risk
Morse Fall Scale (MFS) will be used to assess fall risk. For MFS; A total score between 0-24 indicates a low risk of falling; 25-50 indicates moderate risk of falling, and total score of 51 and above indicates a high risk of falling.
Measured: Through study completion, an average of 5 months
Fall Risk
Missouri Alliance for Home Care (MAHC-10) Fall Risk Assessment Questionnaire will be used to assess fall risk. The MAHC-10 fall risk assessment questionnaire with 10 questions is method for determining the risk of falling in the home environment. The minimum score "0", indicates no risk factors while maximum score "10" indicates that all risk factors are present. A score below 4 indicates no risk of falling, a scores 4 or above indicate high risk of falling.
Measured: Through study completion, an average of 5 months
Vibration Sense
Vibration sense will be assesed from the 1st metatarsal head of the dominant and non-dominant feet using a tuning fork (128 Hz, Mesitas Istanbul, Turkiye). Participants will be asked to start the digital stopwatch in their hand when they felt the vibration and to stop the stopwatch when the vibration ended. The assessment will be repeated three times and the average value will calculate. The values obtained will record in seconds (s). The sensation of vibration felt for more than 10 seconds will be categorized as "normal," felt for 1-9 seconds as "reduced," and felt for less than 1 second as "absent"
Measured: Through study completion, an average of 5 months
Proprioception Sense
Ankle proprioception sense will be evaluated using the angle repetition test. A 180-degree platform drawn at 1° intervals will be used for ankle dorsiflexion and plantar flexion movements. The target angles for the test will be determined as 10° for dorsiflexion movement and 20° for plantar flexion. Before the evaluation, the participants will be asked to perceive that position by passively bringing their feet to the target angles (dorsiflexion: 10°, plantar flexion: 20°). Then, the participants will be asked to actively find the target angles for dorsiflexion and plantar flexion separately, starting from the 0° point with their eyes closed. The margin of error between the reached angles and target angles will be recorded in degrees (°). Measurements will be repeated three times in the side-lying position for both ankles, and the average values will be recorded.
Measured: Through study completion, an average of 5 months
Isometric Muscle Strength
The ankle dorsi flexor, plantar flexor, invertor and evertor isometric muscle strength will be measured using a digital dynamometer (Model-01165, Lafeyette Instrument®, USA) in the supine position, with the knee joint stabilised in extended position with the help of a belt. Three consecutive measurements will be recorded in kilogram and will be averaged. Thirty seconds rest intervals will be given between each measurement.
Measured: Through study completion, an average of 5 months
Static Balance
The "Standing Stork Balance Test (SSBT)" will be used to assess static balance. The participant stands barefoot with their hands on their hips. They lift one leg and place the sole of the lifted foot against the inside of the opposite knee. The timer starts as soon as the participant is in position and stops when: The participant's heel touches the ground. The lifted foot moves away from the knee. The participant loses balance or moves their hands from their hips. Each participant will be performed the test three times and the average time for each leg was recorded as seconds for each sides.
Measured: Through study completion, an average of 5 months
Reaction Time
Foot reaction time will be measured using the MoART (Multi-Operational Apparatus for Reaction Time) Lafayette Reaction Measuring device (Lafayette Instrument Company, Model no. 35601, USA), which is generally used for hand reaction assessments. In this study, the device will be modified for ankle reaction time measurements. For plantar flexor reaction time, the response mode will be set to "press," and for dorsiflexor reaction time, it will be set to "release." Three measurements will be taken for each test on both sides, and the average will be recorded in milliseconds (msec). All measurements will be performed in a quiet environment with participants seated on a back-supported chair.
Measured: Through study completion, an average of 5 months
Postural Stability
The PROKIN-PK200W* (Tecnobody, Italy) device will be used to evaluate postural stability. Four different half-spherical heads can be placed under the mobile platform: easy/shallow, medium, hard/deep or rectangular. In the current study, two measurements will be taken in 30 seconds in bipedal stance with the hands on the waist using the easy head of the device and the average values will be recorded. A total of five different data will be obtained from the participants: total oscillation amount (circumference value), percentage value of the area gap showing the percentage of the area drawn according to the reference circle, oscillation speed, average oscillations in the antero-posterior (AP) and medio-lateral (ML) directions.
Measured: Through study completion, an average of 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start12 Feb 2024
- Primary completion12 Feb 2024
- Study completion22 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Fall RiskStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Cross-Sectional Case Control
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cyprus International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Sıddıka Fatma Uygur, Cyprus International University
- Investigators
- Mehmet Miçooğulları, PhD, Principal investigator, Cyprus International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06891014
- Sponsor's protocol ID
- -020-1285
- Acronym
- FallRisk
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Can be shared upon request.
Publications
Park H, Kim KJ, Komatsu T, Park SK, Mutoh Y. Effect of combined exercise training on bone, body balance, and gait ability: a randomized controlled study in community-dwelling elderly women. J Bone Miner Metab. 2008;26(3):254-9. doi: 10.1007/s00774-007-0819-z. Epub 2008 May 11.
PubMed 18470666Sherrington C, Lord SR, Finch CF. Physical activity interventions to prevent falls among older people: update of the evidence. J Sci Med Sport. 2004 Apr;7(1 Suppl):43-51. doi: 10.1016/s1440-2440(04)80277-9.
PubMed 15214601Loureiro V, Gomes M, Loureiro N, Aibar-Almazan A, Hita-Contreras F. Multifactorial Programs for Healthy Older Adults to Reduce Falls and Improve Physical Performance: Systematic Review. Int J Environ Res Public Health. 2021 Oct 15;18(20):10842. doi: 10.3390/ijerph182010842.
PubMed 34682586Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, Clemson LM, Lamb SE. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD007146. doi: 10.1002/14651858.CD007146.pub3.
PubMed 22972103Toledo DR, Barela JA. Sensory and motor differences between young and older adults: somatosensory contribution to postural control. Rev Bras Fisioter. 2010 May-Jun;14(3):267-75. English, Portuguese.
PubMed 20730372He H, Luo C, Chang X, Shan Y, Cao W, Gong J, Klugah-Brown B, Bobes MA, Biswal B, Yao D. The Functional Integration in the Sensory-Motor System Predicts Aging in Healthy Older Adults. Front Aging Neurosci. 2017 Jan 5;8:306. doi: 10.3389/fnagi.2016.00306. eCollection 2016.
PubMed 28111548
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Regular Exercise on Sensory-motor Functions and Fall Risk in the Elderly
- ClinicalTrials.gov ID
- NCT06891014
- Acronym / sponsor ID
- FallRisk / -020-1285
- Conditions
- Fall Risk, Exercise, Functional Outcomes, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Cyprus International UniversityUniversity, hospital or other
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 12 Feb 2024 (actual)
- Study completion
- 22 May 2024 (actual)
- First posted
- 24 Mar 2025 (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.
Falls in elderly population are an important public health problem. The aim of this study is to examine the vibration, proprioception, muscle strength, static balance, reaction time and postural stability parameters of female individuals aged 65 and over who exercise regularly by comparing them with sedentary female individuals in the same age group and to determine the effect rates of these parameters on fall risk. A total of 92 individuals will evaluate in the study, including 46 participants who perform regular exercise and 46 participants with a sedentary lifestyle. Participants who performs regular exercise will determine among individuals who going to participate in a combined exercise program under the control of a physiotherapist, 2-3 days a week for 8 weeks. The socio-demographic characteristics, health conditions and exercise habits of the participants will be recorded. For evaluating the physical activity levels of the participants, the International Physical Activity Questionnaire-short form (IPAQ-SF); for vibration sense evaluation, 128-Hz frequency tuning fork; for the evaluation of proprioception sense, angle repetition test; for the isometric muscle strength assessment, digital hand dynamometer; for static balance evaluation, standing stork balance test; for reaction time evaluation, MoART measuring device; for postural stability evaluation, PROKIN-PK200W* (Tecnobody, Italy) device and for fall risk assessment, Morse fall scale and MAHC-10 fall questionnaire will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Cross-Sectional Case Control
| Arm | Type | Receives |
|---|---|---|
| Combine Exercise Group | Active comparator | Other: Combine ExerciseParticipants who will participate in a combine exercise program under the control of a physiotherapist, 2-3 days a week for 8 weeks. |
| Control Group | No intervention | –Control Group with a sedentary lifestyle |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Sedentary individuals with an International Physical Activity Questionnaire (IPAQ) score of <600 (for control group)
- Individuals who will be participated in an eight-week regular exercise program (for the exercise group)
- Those who scored 24 or higher on the standardized Mini-Mental State Examination, individuals without communication problems, and those who were not bedridden or wheelchair-bound.
Key exclusion criteria (1 listed)
- Individuals who had received any diagnosis/treatment for spinal or lower extremity problems or had undergone surgery within the last six months, as well as those with severe chronic illnesses or uncontrolled conditions (e.g., hypertension, cancer), will be excluded from the study.
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 |
|---|---|---|
| Combine ExerciseAlso: ExerciseThe participants in the exercise group will be individuals over the age of 65 who applied the same exercise programs 2-3 days a week for 8 weeks under the control of two different physiotherapists independent of the study. The exercise session will be applied for one hour, including a warm-up phase, a combined exercise program including strengthening, stretching, balance and proprioceptive exercises, and a cool-down phase. | Other | Combine Exercise Group |
Primary outcome
Fall Risk
Time frame: Through study completion, an average of 5 months
Morse Fall Scale (MFS) will be used to assess fall risk. For MFS; A total score between 0-24 indicates a low risk of falling; 25-50 indicates moderate risk of falling, and total score of 51 and above indicates a high risk of falling.
Fall Risk
Time frame: Through study completion, an average of 5 months
Missouri Alliance for Home Care (MAHC-10) Fall Risk Assessment Questionnaire will be used to assess fall risk. The MAHC-10 fall risk assessment questionnaire with 10 questions is method for determining the risk of falling in the home environment. The minimum score "0", indicates no risk factors while maximum score "10" indicates that all risk factors are present. A score below 4 indicates no risk of falling, a scores 4 or above indicate high risk of falling.
Vibration Sense
Time frame: Through study completion, an average of 5 months
Vibration sense will be assesed from the 1st metatarsal head of the dominant and non-dominant feet using a tuning fork (128 Hz, Mesitas Istanbul, Turkiye). Participants will be asked to start the digital stopwatch in their hand when they felt the vibration and to stop the stopwatch when the vibration ended. The assessment will be repeated three times and the average value will calculate. The values obtained will record in seconds (s). The sensation of vibration felt for more than 10 seconds will be categorized as "normal," felt for 1-9 seconds as "reduced," and felt for less than 1 second as "absent"
Proprioception Sense
Time frame: Through study completion, an average of 5 months
Ankle proprioception sense will be evaluated using the angle repetition test. A 180-degree platform drawn at 1° intervals will be used for ankle dorsiflexion and plantar flexion movements. The target angles for the test will be determined as 10° for dorsiflexion movement and 20° for plantar flexion. Before the evaluation, the participants will be asked to perceive that position by passively bringing their feet to the target angles (dorsiflexion: 10°, plantar flexion: 20°). Then, the participants will be asked to actively find the target angles for dorsiflexion and plantar flexion separately, starting from the 0° point with their eyes closed. The margin of error between the reached angles and target angles will be recorded in degrees (°). Measurements will be repeated three times in the side-lying position for both ankles, and the average values will be recorded.
Isometric Muscle Strength
Time frame: Through study completion, an average of 5 months
The ankle dorsi flexor, plantar flexor, invertor and evertor isometric muscle strength will be measured using a digital dynamometer (Model-01165, Lafeyette Instrument®, USA) in the supine position, with the knee joint stabilised in extended position with the help of a belt. Three consecutive measurements will be recorded in kilogram and will be averaged. Thirty seconds rest intervals will be given between each measurement.
Static Balance
Time frame: Through study completion, an average of 5 months
The "Standing Stork Balance Test (SSBT)" will be used to assess static balance. The participant stands barefoot with their hands on their hips. They lift one leg and place the sole of the lifted foot against the inside of the opposite knee. The timer starts as soon as the participant is in position and stops when: The participant's heel touches the ground. The lifted foot moves away from the knee. The participant loses balance or moves their hands from their hips. Each participant will be performed the test three times and the average time for each leg was recorded as seconds for each sides.
Reaction Time
Time frame: Through study completion, an average of 5 months
Foot reaction time will be measured using the MoART (Multi-Operational Apparatus for Reaction Time) Lafayette Reaction Measuring device (Lafayette Instrument Company, Model no. 35601, USA), which is generally used for hand reaction assessments. In this study, the device will be modified for ankle reaction time measurements. For plantar flexor reaction time, the response mode will be set to "press," and for dorsiflexor reaction time, it will be set to "release." Three measurements will be taken for each test on both sides, and the average will be recorded in milliseconds (msec). All measurements will be performed in a quiet environment with participants seated on a back-supported chair.
Postural Stability
Time frame: Through study completion, an average of 5 months
The PROKIN-PK200W* (Tecnobody, Italy) device will be used to evaluate postural stability. Four different half-spherical heads can be placed under the mobile platform: easy/shallow, medium, hard/deep or rectangular. In the current study, two measurements will be taken in 30 seconds in bipedal stance with the hands on the waist using the easy head of the device and the average values will be recorded. A total of five different data will be obtained from the participants: total oscillation amount (circumference value), percentage value of the area gap showing the percentage of the area drawn according to the reference circle, oscillation speed, average oscillations in the antero-posterior (AP) and medio-lateral (ML) directions.
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 24 Mar 2025.
- Results publication: PubMed 18470666Park H, Kim KJ, Komatsu T, Park SK, Mutoh Y. Effect of combined exercise training on bone, body balance, and gait ability: a randomized controlled study in community-dwelling elderly women. J Bone Miner Metab. 2008;26(3):254-9. doi: 10.1007/s00774-007-0819-z. Epub 2008 May 11.
- Results publication: PubMed 15214601Sherrington C, Lord SR, Finch CF. Physical activity interventions to prevent falls among older people: update of the evidence. J Sci Med Sport. 2004 Apr;7(1 Suppl):43-51. doi: 10.1016/s1440-2440(04)80277-9.
- Results publication: PubMed 34682586Loureiro V, Gomes M, Loureiro N, Aibar-Almazan A, Hita-Contreras F. Multifactorial Programs for Healthy Older Adults to Reduce Falls and Improve Physical Performance: Systematic Review. Int J Environ Res Public Health. 2021 Oct 15;18(20):10842. doi: 10.3390/ijerph182010842.
- Results publication: PubMed 22972103Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, Clemson LM, Lamb SE. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD007146. doi: 10.1002/14651858.CD007146.pub3.
- Results publication: PubMed 20730372Toledo DR, Barela JA. Sensory and motor differences between young and older adults: somatosensory contribution to postural control. Rev Bras Fisioter. 2010 May-Jun;14(3):267-75. English, Portuguese.
- Results publication: PubMed 28111548He H, Luo C, Chang X, Shan Y, Cao W, Gong J, Klugah-Brown B, Bobes MA, Biswal B, Yao D. The Functional Integration in the Sensory-Motor System Predicts Aging in Healthy Older Adults. Front Aging Neurosci. 2017 Jan 5;8:306. doi: 10.3389/fnagi.2016.00306. eCollection 2016.
- Individual participant dataSharing planned: Yes. Can be shared upon request.
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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.
Mehmet Miçooğulları, PhD principal investigator
Cyprus 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 Combine Exercise in people with Fall Risk and Exercise, run by Cyprus International 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 1 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 24 Mar 2025. 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?
Fall Risk (time frame: Through study completion, an average of 5 months). The study lists 8 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 NCT06891014, which also lists 6 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 24 Mar 2025.