NCT05176912

Brief Summary

Aim: The aim of the study is to investigate the effects of Reformer Pilates exercises in overweight and obese woman. Method: 47 sedentary overweight and obese women aged 30-60 years will be included in the study. Subjects will be divided into two groups: Reformer Pilates and control. The exercise group will be given Reformer Pilates training session 3 times a week over an 8-weeks period. Before and after the study, the subjects will be test for body composition with the bioelectrical impedance and for upper limb strength with the hand grip dynamometer. Moreover, the strength of the back muscle will be measure with the back dynamometer and the strength of the abdominal muscle with the sit-up test. Furthermore, the endurance of trunk, abdominal and back muscles will be measure with the McGill endurance tests. The endurance of the lower limb will be measure with the 30 second sit and stand test, and the balance with the Fullerton Advanced Balance Scale. Finally, the sleep quality will be measure with the Pittsburgh Sleep Quality Index, and the anxiety with the Hospital Anxiety and Depression Scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration 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

June 6, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 4, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2024

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

3.1 years

First QC Date

December 3, 2021

Last Update Submit

July 27, 2024

Conditions

Keywords

Exercise

Outcome Measures

Primary Outcomes (1)

  • Change in the body composition to be evaluated by a bioelectrical impedance

    fat mass and fat-free mass will be evaluated

    Baseline and at the end of 8 weeks.

Secondary Outcomes (1)

  • Change in the level of upper extremity strength to be evaluated by a hand grip dynamometer.

    Baseline and at the end of 8 weeks.

Other Outcomes (9)

  • Change in the level of trunk flexor muscle endurance to be evaluated by a McGill core endurance tests.

    Baseline and at the end of 8 weeks.

  • Change in the level of back extensors muscle endurance to be evaluated by a McGill core endurance tests.

    Baseline and at the end of 8 weeks.

  • Change in the level of lateral muscle endurance to be evaluated by a McGill core endurance tests.

    Baseline and at the end of 8 weeks.

  • +6 more other outcomes

Study Arms (2)

Experimental Exercise Group

EXPERIMENTAL

Reformer Pilates exercises will given for 8 weeks, 3 days in a week.

Other: Exercise

Control Group

NO INTERVENTION

Nothing given to the control group, will be told to continue their normal life for 8 weeks.

Interventions

Reformer Pilates exercises will given for 8 weeks, 3 days in a week

Experimental Exercise Group

Eligibility Criteria

Age30 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteer female individuals between the ages of 30-60 years,
  • BMI: 25 kg/m² and above,
  • Individuals who have not surgery in the last 6 months,
  • Individuals who have a medical report stating that there is no obstacle in terms of health,
  • Individuals whose physical activity level will be determined by the International Physical Activity Questionnaire (IPAQ) will be included in the study.

You may not qualify if:

  • Individuals with any neurological, orthopedis, cardiovascular, psychological problems,
  • Individuals with any systemic disease (DM, cancer),
  • Individuals who doing regular physical activity/sport in the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Mediterranean University

Famagusta, 99628, Cyprus

Location

Related Publications (1)

  • Gokalp O, Kirmizigil B. Effects of reformer pilates on body composition, strength, and psychosomatic factors in overweight and obese women A randomized controlled trial. Sci Rep. 2025 Jul 2;15(1):23602. doi: 10.1038/s41598-025-09683-8.

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Berkiye Kirmizigil, Asst. Prof

    Eastern Mediterranean University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 3, 2021

First Posted

January 4, 2022

Study Start

June 6, 2021

Primary Completion

July 28, 2024

Study Completion

July 28, 2024

Last Updated

July 30, 2024

Record last verified: 2024-07

Locations