NCT07257731

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 2, 2025

Completed
Last Updated

December 2, 2025

Status Verified

November 1, 2025

Enrollment Period

1 month

First QC Date

November 14, 2025

Last Update Submit

November 27, 2025

Conditions

Keywords

Reduced Functional CapacityPhysical Inactivity

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and End of 8-Week Intervention

Secondary Outcomes (4)

  • Balance Functional Reach Test

    Baseline and End of 8-Week Intervention

  • Muscular Endurance 30-Second Push-Up Test

    Baseline and End of 8-Week Intervention

  • Quality of Life Short Form-36 Health Survey (SF-36)

    Baseline and End of 8-Week Intervention

  • Muscular Endurance 30-Second Sit-Up Test

    Baseline and End of 8-Week Intervention

Study Arms (2)

Reformer Pilates Exercise Group

EXPERIMENTAL

8-Week Reformer Pilates Intervention

Behavioral: Reformer Pilates Exercise Program

Control Group

NO INTERVENTION

Usual Lifestyle

Interventions

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.

Reformer Pilates Exercise Group

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale (Kadın)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Aydın Üniversitesi

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator and Physical Therapist (PT)

Study Record Dates

First Submitted

November 14, 2025

First Posted

December 2, 2025

Study Start

May 15, 2025

Primary Completion

June 15, 2025

Study Completion

August 15, 2025

Last Updated

December 2, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
6 months after the primary publication date 5 years after the primary publication date
Access Criteria
Access will be granted to qualified academic and research collaborators who submit a written, methodologically sound research proposal. Data will be shared only after ethical review and approval by the Institutional Review Board (IRB) of Istanbul Aydin University and upon the signing of a formal Data Access Agreement (DAA) with the corresponding author. Access will be provided to the anonymized Individual Participant Data (IPD), the full study protocol, the Statistical Analysis Plan (SAP), the Informed Consent Form (ICF), the Clinical Study Report (CSR), and analytic code for ethically approved and scientifically justifiable research purposes.

Locations