Effects of Regular Exercise on Sensory-motor Functions and Fall Risk in the Elderly (FallRisk)

March 20, 2025 updated by: Prof. Dr. Sıddıka Fatma Uygur, Cyprus International University
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
92

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Haspolat
      • Mersin, Haspolat, Turkey
        • Cyprus International University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Combine Exercise Group
Participants who will participate in a combine exercise program under the control of a physiotherapist, 2-3 days a week for 8 weeks.
Other: Combine 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.
Other Names:
  • Exercise
No Intervention: Control Group
Control Group with a sedentary lifestyle

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 5 months
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.
Through study completion, an average of 5 months
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"
Through study completion, an average of 5 months
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.
Through study completion, an average of 5 months
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.
Through study completion, an average of 5 months
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.
Through study completion, an average of 5 months
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.
Through study completion, an average of 5 months
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.
Through study completion, an average of 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cyprus International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mehmet Miçooğulları, PhD, Cyprus International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 12, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 12, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 22, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • -020-1285

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Can be shared upon request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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