Sedentary LifestyleNCT07257731
The Effect of Reformer Pilates on Functional Capacity, Balance, and Quality of Life in Sedentary Women
A study testing Reformer Pilates Exercise Program in people with Sedentary Lifestyle and Functional Capacity, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
Trial summary
The objective of this randomized controlled trial is to evaluate the effect of Reformer Pilates exercises on functional capacity, balance, muscular endurance, and quality of life in sedentary women. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Sedentary Lifestyle, Functional Capacity
- What is being tested?
- Reformer Pilates Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2025to 15 Aug 2025
- 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 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female gender.
- Meeting the definition of sedentary (no participation in any regular exercise program within the last 6 months).
- Having sufficient ability to understand and comply with the study procedures.
- No physical or mental condition that would hinder safe participation in the study.
- Voluntarily agreeing to participate in the study and signing the informed consent form.
Who cannot join
- Presence of any neurological disorder that prevents safe exercise participation.
- Having an active sports life or currently participating in regular sports activities.
- Presence of cardiovascular, pulmonary, or serious orthopedic problems that contraindicate exercise (e.g., medical restriction by a physician).
- Being pregnant or breastfeeding.
- Presence of any acute pain or inflammatory condition.
- Having a known contraindication for Pilates exercises.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Reformer Pilates Exercises on Functional Capacity, Balance, Muscular Endurance, and Quality of Life in Sedentary Women: A Randomized Controlled Trial
The objective of this randomized controlled trial is to evaluate the effect of Reformer Pilates exercises on functional capacity, balance, muscular endurance, and quality of life in sedentary women.
A total of 57 sedentary women were randomly assigned to either the Intervention Group (N=30) or the Control Group (N=27). Participants in the intervention group underwent an 8-week Reformer Pilates exercise program, consisting of 2 sessions per week, 50 minutes each. The control group maintained their usual lifestyle without intervention. All participants' functional capacity (1-minute sit-to-stand), balance (Functional Reach Test), muscular endurance (30-second push-up and sit-up tests), and quality of life (SF-36) were measured at baseline and at the end of the 8-week period.
Read the detailed description
In the modern world, technological advances and evolving lifestyles have led to a significant global public health concern: the sedentary lifestyle. Sedentary behavior is defined by low energy expenditure ($\le 1.5$ METs) during activities like sitting or lying down. This trend contributes to the rise of chronic diseases, including cardiovascular conditions, Type 2 diabetes, and musculoskeletal disorders, placing a substantial burden on health systems.Women are particularly vulnerable to decreased physical activity due to physiological factors (e.g., pregnancy, menopause) and sociocultural aspects. This physical inactivity is linked to reduced muscle mass, bone density, poor functional capacity, and increased risk of falls. Furthermore, sedentary behaviors adversely affect psychosocial well-being, contributing to increased depression, anxiety, and a reduced overall quality of life.The Reformer Pilates method, based on principles such as core stabilization, control, and breathing, is a comprehensive exercise approach aimed at improving strength, flexibility, posture, and balance. The Reformer apparatus, with its springs and movable carriage, provides adjustable resistance and support, making it an efficient and safe exercise option, particularly for sedentary individuals. While existing literature supports the benefits of Pilates, there is a distinct gap regarding the combined effects of Reformer Pilates (not Mat Pilates) on the crucial parameters of functional capacity, balance, muscular endurance, and quality of life within the sedentary female population, using a high-evidence-level randomized controlled trial (RCT) design. This study aims to address this critical scientific gap.STUDY OBJECTIVE AND DESIGNThe primary objective of this study is to evaluate the effect of an 8-week Reformer Pilates exercise program on the levels of functional capacity, balance, muscular endurance, and quality of life in sedentary women, compared to a control group.This investigation is designed as a Randomized Controlled Trial (RCT). A total of 57 sedentary women were randomly assigned to either the Intervention Group (N=30) or the Control Group (N=27).INTERVENTION PROTOCOLIntervention Group: Participants in this group underwent an 8-week Reformer Pilates exercise program. The program involved 2 sessions per week, with each session lasting 50 minutes. All sessions were administered by the same physical therapist at a dedicated center (FLC Konsept Sağlıklı Yaşam Merkezi). The exercise protocol was standardized but personalized: the spring resistance on the Reformer apparatus was adjusted based on the individual participant's physical condition and tolerance to maximize efficiency and safety.Control Group: Participants in this group maintained their usual lifestyle and daily routine throughout the 8-week study period, without receiving any structured exercise intervention.OUTCOME MEASURESAll participants underwent comprehensive assessments at baseline and at the end of the 8-week intervention period. Measurements were taken by the same blinded physical therapist to ensure reliability and minimize bias.The primary outcome and secondary outcomes are defined as follows:Functional Capacity: Measured using the 1-Minute Sit-to-Stand Test.Balance: Measured using the Functional Reach Test.Muscular Endurance: Measured using the 30-Second Push-Up Test and the 30-Second Sit-Up Test.Quality of Life: Measured using the Short Form-36 Health Survey (SF-36) scale.
- Conditions
- Sedentary Lifestyle, Functional Capacity
- Being tested
- Reformer Pilates Exercise Program
- Keywords
- Reduced Functional Capacity, Physical Inactivity
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reformer Pilates Exercise ProgramBehavioural
The Reformer Pilates Exercise Program was delivered over an 8-week period, consisting of 2 supervised sessions per week. Each session lasted 50 minutes and was administered by the same licensed Physical Therapist (PT) at the FLC Konsept Healthy Living Center. The exercises utilized the Reformer apparatus. The program was standardized but individually tailored by adjusting the spring resistance based on the participant's tolerance level and physical condition to ensure safe and effective exercise progression. The intervention focused on the six core principles of Pilates, targeting core stabilization, muscle strength, muscular endurance, flexibility, and balance to improve the overall physical fitness of sedentary women.
| Study group | Role | What they receive |
|---|---|---|
| Reformer Pilates Exercise Group | Experimental | 8-Week Reformer Pilates Intervention Receives: Behavioral: Reformer Pilates Exercise Program |
| Control Group | No intervention | Usual Lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Capacity 1-Minute Sit-to-Stand Test
The 1-Minute Sit-to-Stand Test (1-MSTST) is a standardized, reliable, and valid field test designed to assess lower-body strength, muscular endurance, and functional mobility in various populations, including sedentary adults.
Procedure: The participant is instructed to stand up fully from a standard chair and sit down as many times as possible within a one-minute period, without using their arms for support.
Scoring: The total number of complete repetitions performed correctly within 60 seconds is recorded as the test score. A higher number of repetitions indicates superior functional capacity and strength, often correlated with better mobility and reduced fall risk.
Measured: Baseline and End of 8-Week Intervention
Secondary outcomes (4)
Balance Functional Reach Test
The Functional Reach Test (FRT) is a simple, single-measure clinical assessment designed to evaluate dynamic balance and postural stability by quantifying a participant's ability to intentionally displace their center of gravity forward.
Procedure: The participant stands next to a wall-mounted ruler, with the arm extended forward at 90 degrees. They are instructed to reach as far forward as possible without moving their feet or touching the wall. The measure is the maximum distance (typically in centimeters) between the initial position of the third metacarpal head and the final reached position.
Interpretation: A higher score (longer reach distance) indicates superior balance, better postural control, and is associated with a lower risk of falls. Conversely, a reduced reach distance is a reliable predictor of increased fall risk and poor functional mobility.
Measured: Baseline and End of 8-Week Intervention
Muscular Endurance 30-Second Push-Up Test
30-Second Push-Up Test: Measures the endurance of the upper body muscles (chest, shoulders, and triceps). Participants perform maximum repetitions in 30 seconds, using a modified knee-supported position for women (if applicable to your protocol). Scoring: The total number of complete and correct repetitions performed within the 30-second period for this test is recorded. A higher score indicates superior upper body muscular endurance.
Measured: Baseline and End of 8-Week Intervention
Quality of Life Short Form-36 Health Survey (SF-36)
The Short Form-36 Health Survey (SF-36) is a validated, standardized, and self-administered questionnaire measuring generic health status and health-related quality of life. It provides scores on eight distinct health domains:
Physical Functioning (PF)
Role Limitations due to Physical Health (RP)
Bodily Pain (BP)
General Health (GH)
Vitality (VT)
Social Functioning (SF)
Role Limitations due to Emotional Problems (RE)
Mental Health (MH)
These eight scales are summarized into two key components: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Scores range from 0 (worst health) to 100 (best health).
Measured: Baseline and End of 8-Week Intervention
Muscular Endurance 30-Second Sit-Up Test
30-Second Sit-Up Test: Measures the endurance of the core (abdominal) musculature. Participants perform maximum repetitions in 30 seconds, typically with the knees bent and feet held, touching the elbow to the thigh for each repetition. Scoring: The total number of complete and correct repetitions performed within the 30-second period for this test is recorded. A higher score indicates superior core muscular endurance.
Measured: Baseline and End of 8-Week Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start15 May 2025
- Primary completion15 Jun 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary LifestyleStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Aydın University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ece turak, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257731
- Sponsor's protocol ID
- 126/2025
- Other IDs
- IRB Protocol Number
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data (IPD) that support the results of this study will be shared upon reasonable request to the corresponding author, following the publication of the final results. The data will be de-identified to protect participant privacy. Data will be made available for researchers who provide a methodologically sound proposal and sign a data access agreement. The types of data shared will include the full protocol, statistical analysis plan, and the raw dataset after anonymization.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reformer Pilates Exercises on Functional Capacity, Balance, Muscular Endurance, and Quality of Life in Sedentary Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07257731
- Acronym / sponsor ID
- 126/2025
- Conditions
- Sedentary Lifestyle, Functional Capacity
- Keywords
- Reduced Functional Capacity, Physical Inactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Istanbul Aydın UniversityUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 2 Dec 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.
The objective of this randomized controlled trial is to evaluate the effect of Reformer Pilates exercises on functional capacity, balance, muscular endurance, and quality of life in sedentary women.
A total of 57 sedentary women were randomly assigned to either the Intervention Group (N=30) or the Control Group (N=27). Participants in the intervention group underwent an 8-week Reformer Pilates exercise program, consisting of 2 sessions per week, 50 minutes each. The control group maintained their usual lifestyle without intervention. All participants' functional capacity (1-minute sit-to-stand), balance (Functional Reach Test), muscular endurance (30-second push-up and sit-up tests), and quality of life (SF-36) were measured at baseline and at the end of the 8-week period.
Detailed description
In the modern world, technological advances and evolving lifestyles have led to a significant global public health concern: the sedentary lifestyle. Sedentary behavior is defined by low energy expenditure ($\le 1.5$ METs) during activities like sitting or lying down. This trend contributes to the rise of chronic diseases, including cardiovascular conditions, Type 2 diabetes, and musculoskeletal disorders, placing a substantial burden on health systems.Women are particularly vulnerable to decreased physical activity due to physiological factors (e.g., pregnancy, menopause) and sociocultural aspects. This physical inactivity is linked to reduced muscle mass, bone density, poor functional capacity, and increased risk of falls. Furthermore, sedentary behaviors adversely affect psychosocial well-being, contributing to increased depression, anxiety, and a reduced overall quality of life.The Reformer Pilates method, based on principles such as core stabilization, control, and breathing, is a comprehensive exercise approach aimed at improving strength, flexibility, posture, and balance. The Reformer apparatus, with its springs and movable carriage, provides adjustable resistance and support, making it an efficient and safe exercise option, particularly for sedentary individuals. While existing literature supports the benefits of Pilates, there is a distinct gap regarding the combined effects of Reformer Pilates (not Mat Pilates) on the crucial parameters of functional capacity, balance, muscular endurance, and quality of life within the sedentary female population, using a high-evidence-level randomized controlled trial (RCT) design. This study aims to address this critical scientific gap.STUDY OBJECTIVE AND DESIGNThe primary objective of this study is to evaluate the effect of an 8-week Reformer Pilates exercise program on the levels of functional capacity, balance, muscular endurance, and quality of life in sedentary women, compared to a control group.This investigation is designed as a Randomized Controlled Trial (RCT). A total of 57 sedentary women were randomly assigned to either the Intervention Group (N=30) or the Control Group (N=27).INTERVENTION PROTOCOLIntervention Group: Participants in this group underwent an 8-week Reformer Pilates exercise program. The program involved 2 sessions per week, with each session lasting 50 minutes. All sessions were administered by the same physical therapist at a dedicated center (FLC Konsept Sağlıklı Yaşam Merkezi). The exercise protocol was standardized but personalized: the spring resistance on the Reformer apparatus was adjusted based on the individual participant's physical condition and tolerance to maximize efficiency and safety.Control Group: Participants in this group maintained their usual lifestyle and daily routine throughout the 8-week study period, without receiving any structured exercise intervention.OUTCOME MEASURESAll participants underwent comprehensive assessments at baseline and at the end of the 8-week intervention period. Measurements were taken by the same blinded physical therapist to ensure reliability and minimize bias.The primary outcome and secondary outcomes are defined as follows:Functional Capacity: Measured using the 1-Minute Sit-to-Stand Test.Balance: Measured using the Functional Reach Test.Muscular Endurance: Measured using the 30-Second Push-Up Test and the 30-Second Sit-Up Test.Quality of Life: Measured using the Short Form-36 Health Survey (SF-36) scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reformer Pilates Exercise Group | Experimental | Behavioral: Reformer Pilates Exercise Program8-Week Reformer Pilates Intervention |
| Control Group | No intervention | –Usual Lifestyle |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female gender.
- Meeting the definition of sedentary (no participation in any regular exercise program within the last 6 months).
- Having sufficient ability to understand and comply with the study procedures.
- No physical or mental condition that would hinder safe participation in the study.
- Voluntarily agreeing to participate in the study and signing the informed consent form.
Key exclusion criteria (6 listed)
- Presence of any neurological disorder that prevents safe exercise participation.
- Having an active sports life or currently participating in regular sports activities.
- Presence of cardiovascular, pulmonary, or serious orthopedic problems that contraindicate exercise (e.g., medical restriction by a physician).
- Being pregnant or breastfeeding.
- Presence of any acute pain or inflammatory condition.
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 |
|---|---|---|
| Reformer Pilates Exercise ProgramThe Reformer Pilates Exercise Program was delivered over an 8-week period, consisting of 2 supervised sessions per week. Each session lasted 50 minutes and was administered by the same licensed Physical Therapist (PT) at the FLC Konsept Healthy Living Center. The exercises utilized the Reformer apparatus. The program was standardized but individually tailored by adjusting the spring resistance based on the participant's tolerance level and physical condition to ensure safe and effective exercise progression. The intervention focused on the six core principles of Pilates, targeting core stabilization, muscle strength, muscular endurance, flexibility, and balance to improve the overall physical fitness of sedentary women. | Behavioural | Reformer Pilates Exercise Group |
Primary outcome
Functional Capacity 1-Minute Sit-to-Stand Test
Time frame: Baseline and End of 8-Week Intervention
The 1-Minute Sit-to-Stand Test (1-MSTST) is a standardized, reliable, and valid field test designed to assess lower-body strength, muscular endurance, and functional mobility in various populations, including sedentary adults. Procedure: The participant is instructed to stand up fully from a standard chair and sit down as many times as possible within a one-minute period, without using their arms for support. Scoring: The total number of complete repetitions performed correctly within 60 seconds is recorded as the test score. A higher number of repetitions indicates superior functional capacity and strength, often correlated with better mobility and reduced fall risk.
4 secondary outcomes
Balance Functional Reach Test
Time frame: Baseline and End of 8-Week Intervention
Muscular Endurance 30-Second Push-Up Test
Time frame: Baseline and End of 8-Week Intervention
Quality of Life Short Form-36 Health Survey (SF-36)
Time frame: Baseline and End of 8-Week Intervention
Muscular Endurance 30-Second Sit-Up Test
Time frame: Baseline and End of 8-Week Intervention
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 2 Dec 2025.
- Individual participant dataSharing planned: Yes. The individual participant data (IPD) that support the results of this study will be shared upon reasonable request to the corresponding author, following the publication of the final results. The data will be de-identified to protect participant privacy. Data will be made available for researchers who provide a methodologically sound proposal and sign a data access agreement. The types of data shared will include the full protocol, statistical analysis plan, and the raw dataset after anonymization.
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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 Reformer Pilates Exercise Program in people with Sedentary Lifestyle and Functional Capacity, run by Istanbul Aydın 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 5 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 2 Dec 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?
Functional Capacity 1-Minute Sit-to-Stand Test (time frame: Baseline and End of 8-Week Intervention). 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 2 Dec 2025.