- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07257731
The Effect of Reformer Pilates on Functional Capacity, Balance, and Quality of Life in Sedentary Women
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey (Türkiye)
- İstanbul Aydın Üniversitesi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Reformer Pilates Exercise Group
8-Week Reformer Pilates Intervention
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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.
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No Intervention: Control Group
Usual Lifestyle
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Baseline and End of 8-Week Intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balance Functional Reach Test
Time Frame: Baseline and End of 8-Week Intervention
|
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. |
Baseline and End of 8-Week Intervention
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Muscular Endurance 30-Second Push-Up Test
Time Frame: Baseline and End of 8-Week Intervention
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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.
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Baseline and End of 8-Week Intervention
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Quality of Life Short Form-36 Health Survey (SF-36)
Time Frame: Baseline and End of 8-Week Intervention
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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). |
Baseline and End of 8-Week Intervention
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Muscular Endurance 30-Second Sit-Up Test
Time Frame: Baseline and End of 8-Week Intervention
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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.
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Baseline and End of 8-Week Intervention
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 126/2025
- IRB Protocol Number (Other Identifier: Istanbul Aydin University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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