NCT07134517

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 21, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

August 21, 2025

Status Verified

August 1, 2025

Enrollment Period

5 months

First QC Date

July 14, 2025

Last Update Submit

August 19, 2025

Conditions

Keywords

Pilatescognitive functionphysical fitness

Outcome Measures

Primary Outcomes (1)

  • 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.

    8 weeks

Secondary Outcomes (10)

  • Tracking test

    8 weeks

  • Reaction time (Time)

    8 weeks

  • Reaction time (Count)

    8 weeks

  • Assessment of Physical Fitness

    8 weeks

  • Grip Strength Test

    8 weeks

  • +5 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

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.

Intervention group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Exercise Movement Techniques

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Central Study Contacts

Büşra Candiri, Assistant+ Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 14, 2025

First Posted

August 21, 2025

Study Start

September 1, 2025

Primary Completion

February 1, 2026

Study Completion

March 1, 2026

Last Updated

August 21, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share