Healthy Volunteers (HV)NCT07134517
Examining the Effects of Reformer Pilates Exercises on Physical Fitness and Cognitive Functions in Healthy Individuals
A study testing Pilates exercise in people with Healthy Volunteers (HV), run by Inonu University.
Trial summary
Pilates is an exercise method that aims to increase body awareness and improve physical fitness through controlled movements based on mind-body integration. Reformer Pilates strengthens the mind-body connection while increasing core muscle activation through equipment-assisted exercises. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers (HV)
- What is being tested?
- Pilates exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals who do not have a regular exercise habit,
- Are between the ages of 18 and 50,
- And are inactive according to the International Physical Activity Questionnaire Short Form assessment (less than 600 MET min).
Who cannot join
- Individuals with a history of serious musculoskeletal or neurological disease,
- Receiving psychological support,
- Taking regular medication,
- With metabolic disease,
- Describing chronic pain anywhere in their body,
- Or with communication problems.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Pilates is an exercise method that aims to increase body awareness and improve physical fitness through controlled movements based on mind-body integration. Reformer Pilates strengthens the mind-body connection while increasing core muscle activation through equipment-assisted exercises. It is known that regular exercise has positive effects on cognitive functions through its neuroprotective and neuroplastic effects. However, the effects of Reformer Pilates on these functions have been studied in only a limited number of studies, particularly in healthy middle-aged individuals. The aim of this project proposal is to investigate the effectiveness of Reformer Pilates exercises on physical fitness and cognitive functions in healthy individuals. In this study, the effects of reformer Pilates on physical fitness and cognitive functions will be examined in healthy individuals aged 18-50. The intervention group will perform reformer Pilates twice a week for 8 weeks, while the control group will not participate in any physical activity. Body mass index, waist-to-height ratio, waist-to-hip ratio, cognitive reserve, cognitive functions, reaction time, physical fitness, grip strength, and general health status will be assessed at baseline and after 8 weeks. Cognitive functions will be assessed using the cognitive reserve index, and cognitive functions will be assessed using the Stroop test-anchor form and the tracking test. Stroop test-anchor form and tracking test; reaction time will be measured using a wireless system consisting of a laser LED light emitter and a central hand control unit; physical fitness will be assessed using The Senior Fitness Test; grip strength will be measured using a hand dynamometer; and general health status will be assessed using the General Health Questionnaire-12. Data analysis will be performed using SPSS version 25.0. For comparing pre- and post-treatment outcome measures within the group, analysis will be conducted using the t-test for dependent samples (if normally distributed) or the Wilcoxon signed-rank test (if not normally distributed). Effect size will be calculated to determine the impact of the exercise program. P<0.05 will be considered statistically significant.
- Conditions
- Healthy Volunteers (HV)
- Being tested
- Pilates exercise
- Keywords
- Pilates, cognitive function, physical fitness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates exerciseOther
The principles of centering, concentration, breathing, control, flow, and precision in the Pilates method will be explained to participants. Pelvic floor activity and lateral breathing will be taught and practiced, along with neutral spine alignment. The first and last 5 minutes of each session will consist of stretching exercises. Stretching exercises will begin with 3-5 repetitions, while strengthening and stabilization exercises will start with 6-8 repetitions, with the number of repetitions increasing each week based on participants' tolerance. Springs are attached according to the purpose and difficulty level of the exercises. Stretching exercises are performed with lighter resistance springs, while strengthening and stabilization exercises are performed with higher resistance springs. All movements will be demonstrated and explained to ensure the exercises are performed correctly. Verbal cues will be given for breath control and centering.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group in this study will consist of individuals who perform reformer Pilates exercises twice a week for a total of 16 sessions over an 8-week period. Receives: Other: Pilates exercise |
| Control group | No intervention | The control group will consist of individuals who do not actively participate in reformer Pilates or any other sports activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroop Test - Anchor Form
The Stroop Test, developed by Stroop in 1935, is a test used to assess selective attention, cognitive flexibility, inhibition skills, and information processing speed. Successful performance requires suppressing processes unrelated to the task and focusing on processes related to the task. There are many types of forms used in the Stroop Test. In Turkey, the Stroop Test Çapa form, whose validity and reliability were established by Emek Savaş et al., is widely used. In this study, the Stroop Test-Çapa Form will be used to assess individuals' cognitive flexibility. The test consists of a total of 60 items. A long test duration and a high number of errors indicate weak cognitive flexibility.
Measured: 8 weeks
Secondary outcomes (10)
Tracking test
It was developed by Reitan (1955). It measures executive functions such as working memory, complex attention, planning, and set-shifting abilities. It consists of two sections, A and B. Section A contains circles with numbers scattered on an A4 sheet of paper. In section A, participants are asked to connect the numbers inside the circles in order (1-2-3-...) by drawing a line. In section B, there are circles scattered on an A4 sheet of paper, but these circles contain both numbers and letters. In this section, participants are asked to connect the numbers and letters inside the circles in alternating order (1-A-2-B-...), one number followed by one letter. Section A assesses processing speed, while Section B assesses set-shifting, response inhibition, and interference resistance skills.
Measured: 8 weeks
Reaction time (Time)
Upper and lower extremity reaction time will be measured using a wireless system consisting of a laser LED light emitter and a central hand control unit. For the lower extremity reaction time assessment, individuals are asked to extinguish four randomly lit LEDs placed on the ground at 1-meter intervals as quickly as possible within a 30-second time frame while standing on one foot. The assessment will be recorded separately for the right and left legs. The unit extinguishing time in milliseconds are recorded. For the upper extremity reaction time assessment, participants are asked to extinguish five LEDs on a table as quickly as possible with one hand while in a sitting position. The right and left hands are evaluated separately. The unit extinguishing time in milliseconds are recorded.
Measured: 8 weeks
Reaction time (Count)
Upper and lower extremity reaction time will be measured using a wireless system consisting of a laser LED light emitter and a central hand control unit. For the lower extremity reaction time assessment, individuals are asked to extinguish four randomly lit LEDs placed on the ground at 1-meter intervals as quickly as possible within a 30-second time frame while standing on one foot. The assessment will be recorded separately for the right and left legs. The number of LEDs that can be extinguished within 30 seconds,and the number of LEDs missed after the 5-second light emission period are recorded. For the upper extremity reaction time assessment, participants are asked to extinguish five LEDs on a table as quickly as possible with one hand while in a sitting position. The right and left hands are evaluated separately.
Measured: 8 weeks
Assessment of Physical Fitness
The Senior Fitness Test will be used to assess physical fitness. It consists of six functional tests that measure strength, endurance, balance, agility, and flexibility.
Measured: 8 weeks
Grip Strength Test
Hand grip strength will be measured using a hand dynamometer. Participants will sit with their shoulders adducted alongside their torso, elbows flexed at 90°, forearms in a neutral position, and wrists in 0-30° extension and 0-15° ulnar deviation. Each participant will perform two trials with each hand, with a 30-second rest between trials. The highest score obtained from the dominant hand will be recorded for analysis.
Measured: 8 weeks
General Health Survey-12
A self-report tool developed by David Goldberg to screen individuals' mental health and determine their overall psychological health level. It is used to identify conditions such as depression, anxiety, impaired social functioning, and psychological stress at an early stage. It was developed to identify individuals at risk of mental health issues in non-clinical populations and is frequently used in community screenings, primary care settings, and epidemiological studies.
Measured: 8 weeks
Cognitive Reserve Index Questionnaire
Nucci et al. developed and standardized the Cognitive Reserve Index Questionnaire to measure an individual's cognitive reserve in three dimensions: education, work activity, and participation in leisure activities. This questionnaire is applied among items by taking into account the frequency of an individual's participation in cognitively challenging activities throughout their life. The validity and reliability of the questionnaire for the Turkish population were established by Özakbaş et al. in 2021.It's a questionnaire that collects information under three main headings. Scores from all three domains are normalized and combined to calculate an overall cognitive reserve score. Low scores indicate low cognitive reserve, while high scores indicate high cognitive reserve.
Measured: 8 weeks
Body mass index
Body mass index is calculated by dividing body weight by the square of height in meters (kg/m2).
Measured: 8 weeks
Waist/Height Ratio
Waist circumference is measured in centimeters at the narrowest part of the waist, at the level of the lowest rib at the end of exhalation, over underwear while the individual is standing, using a loose, non-stretchable tape measure. Height is also measured in centimeters, and waist circumference is divided by height, calculating the waist-to-height ratio.
Measured: 8 weeks
Waist-hip ratio
Waist-hip ratio will be determined by dividing waist circumference (cm) by hip circumference (cm) and recorded in centimeters.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers (HV)Studies of the same condition, open and under way.
- More trials run by Inonu 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BÜŞRA CANDİRİ, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07134517
- Sponsor's protocol ID
- 2025/8028
- Status last verified
- Aug 2025
- First submitted
- 14 Jul 2025
- Last updated
- 21 Aug 2025
- Results posted
- 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 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effects of Reformer Pilates Exercises on Physical Fitness and Cognitive Functions in Healthy Individuals
- ClinicalTrials.gov ID
- NCT07134517
- Acronym / sponsor ID
- 2025/8028
- Conditions
- Healthy Volunteers (HV)
- Keywords
- Pilates, cognitive function, physical fitness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 21 Aug 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.
Pilates is an exercise method that aims to increase body awareness and improve physical fitness through controlled movements based on mind-body integration. Reformer Pilates strengthens the mind-body connection while increasing core muscle activation through equipment-assisted exercises. It is known that regular exercise has positive effects on cognitive functions through its neuroprotective and neuroplastic effects. However, the effects of Reformer Pilates on these functions have been studied in only a limited number of studies, particularly in healthy middle-aged individuals. The aim of this project proposal is to investigate the effectiveness of Reformer Pilates exercises on physical fitness and cognitive functions in healthy individuals. In this study, the effects of reformer Pilates on physical fitness and cognitive functions will be examined in healthy individuals aged 18-50. The intervention group will perform reformer Pilates twice a week for 8 weeks, while the control group will not participate in any physical activity. Body mass index, waist-to-height ratio, waist-to-hip ratio, cognitive reserve, cognitive functions, reaction time, physical fitness, grip strength, and general health status will be assessed at baseline and after 8 weeks. Cognitive functions will be assessed using the cognitive reserve index, and cognitive functions will be assessed using the Stroop test-anchor form and the tracking test. Stroop test-anchor form and tracking test; reaction time will be measured using a wireless system consisting of a laser LED light emitter and a central hand control unit; physical fitness will be assessed using The Senior Fitness Test; grip strength will be measured using a hand dynamometer; and general health status will be assessed using the General Health Questionnaire-12. Data analysis will be performed using SPSS version 25.0. For comparing pre- and post-treatment outcome measures within the group, analysis will be conducted using the t-test for dependent samples (if normally distributed) or the Wilcoxon signed-rank test (if not normally distributed). Effect size will be calculated to determine the impact of the exercise program. P<0.05 will be considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Pilates exerciseThe intervention group in this study will consist of individuals who perform reformer Pilates exercises twice a week for a total of 16 sessions over an 8-week period. |
| Control group | No intervention | –The control group will consist of individuals who do not actively participate in reformer Pilates or any other sports activities. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Individuals who do not have a regular exercise habit,
- Are between the ages of 18 and 50,
- And are inactive according to the International Physical Activity Questionnaire Short Form assessment (less than 600 MET min).
Key exclusion criteria (6 listed)
- Individuals with a history of serious musculoskeletal or neurological disease,
- Receiving psychological support,
- Taking regular medication,
- With metabolic disease,
- Describing chronic pain anywhere in their body,
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 |
|---|---|---|
| Pilates exerciseThe principles of centering, concentration, breathing, control, flow, and precision in the Pilates method will be explained to participants. Pelvic floor activity and lateral breathing will be taught and practiced, along with neutral spine alignment. The first and last 5 minutes of each session will consist of stretching exercises. Stretching exercises will begin with 3-5 repetitions, while strengthening and stabilization exercises will start with 6-8 repetitions, with the number of repetitions increasing each week based on participants' tolerance. Springs are attached according to the purpose and difficulty level of the exercises. Stretching exercises are performed with lighter resistance springs, while strengthening and stabilization exercises are performed with higher resistance springs. All movements will be demonstrated and explained to ensure the exercises are performed correctly. Verbal cues will be given for breath control and centering. | Other | Intervention group |
Primary outcome
Stroop Test - Anchor Form
Time frame: 8 weeks
The Stroop Test, developed by Stroop in 1935, is a test used to assess selective attention, cognitive flexibility, inhibition skills, and information processing speed. Successful performance requires suppressing processes unrelated to the task and focusing on processes related to the task. There are many types of forms used in the Stroop Test. In Turkey, the Stroop Test Çapa form, whose validity and reliability were established by Emek Savaş et al., is widely used. In this study, the Stroop Test-Çapa Form will be used to assess individuals' cognitive flexibility. The test consists of a total of 60 items. A long test duration and a high number of errors indicate weak cognitive flexibility.
10 secondary outcomes
Tracking test
Time frame: 8 weeks
Reaction time (Time)
Time frame: 8 weeks
Reaction time (Count)
Time frame: 8 weeks
Assessment of Physical Fitness
Time frame: 8 weeks
Grip Strength Test
Time frame: 8 weeks
General Health Survey-12
Time frame: 8 weeks
Cognitive Reserve Index Questionnaire
Time frame: 8 weeks
Body mass index
Time frame: 8 weeks
Waist/Height Ratio
Time frame: 8 weeks
Waist-hip ratio
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates exercise in people with Healthy Volunteers (HV), run by Inonu University.
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 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: opening soon, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Büşra Candiri, Assistant+ Professor (+905073780717, busracandiri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroop Test - Anchor Form (time frame: 8 weeks). 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 21 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.