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Completed

NCT Number: NCT05176912

Effects of Reformer Pilates Exercise Training

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.

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Key information

Age range

30 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Eastern Mediterranean University

Famagusta, 99628, Cyprus

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Exercise

Other

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

Primary outcomes

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

    Time frame: Baseline and at the end of 8 weeks.

    fat mass and fat-free mass will be evaluated

Secondary outcomes

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

    Time frame: Baseline and at the end of 8 weeks.

    The subject sits upright in a supported chair and on a flat surface. The person is prepared with the knee and hip in 90⁰ flexion, forearm in neutral position and wrist in 0-30⁰ extension. During the measurement, the person whose grip strength is measured is asked to squeeze the arms of the dynamometer strongly.

Other outcomes

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

    Time frame: Baseline and at the end of 8 weeks.

    The trunk flexor endurance test begins with the person in a sit-up position with the back resting against a jig angled at 60 degrees from the floor. Both knees and hips are flexed 90 degrees, the arms are folded across the chest with the hands placed on the opposite shoulder, and the feet are secured. After the apparatus is removed, the person maintains the isometric posture for as long as possible.

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

    Time frame: Baseline and at the end of 8 weeks.

    The back extensors are tested with the upper body cantilevered out over the end of the test bench and with the pelvis, knees, and hips secured. The upper limbs are held across the chest with the hands resting on the opposite shoulders.

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

    Time frame: Baseline and at the end of 8 weeks.

    The lateral muscle is tested with the person lying in the full side-bridge position.

  4. Change in the strength of the back to be evaluated by back dynamometer.

    Time frame: Baseline and at the end of 8 weeks.

    Back dynamometer: The measure strength of back muscles. Subject stand with knees fully extended and head and back straight. They use over-under grip with the bar across the thighs. They should pull the bar straight up by rolling shoulders without bending them back.

  5. Change in the strength of the abdominal muscle to be evaluated by sit-up test.

    Time frame: Baseline and at the end of 8 weeks.

    Sit-up test: The measure strength of abdominal muscles. The subjects lying on the floor supine position. The knees are flexed at an angle of 90°, and an assistant supports the ankles. The subject raises upper body and then returns to the starting position.

  6. Change in the endurance of the lower extremity to be evaluated by 30 second sit and stand test.

    Time frame: Baseline and at the end of 8 weeks.

    The chair-stand test administer using a folding chair without arms, with a seat height of 17 inches (43.2 cm). The test begin with the participant seated in the middle of the chair, back straight, feet approximately shoulder-width apart and placed on the floor at an angle slightly back from the knees. Arms cross at the wrists and held against the chest. At the signal 'go', the participant rise to a full stand and then return back to the seated position. The participants encourage to complete as many full stands as possible within 30-s time limit.

  7. Change in the balance to be evaluated by Fullerton Advanced Balance Scale.

    Time frame: Baseline and at the end of 8 weeks.

    The Fullerton Test is mainly intended to identify highly-active older adults who are at an increased risk to experience fall-related injuries due to sensory impairments. The test uses both dynamic and static balance under different situations to identify balance deficits in older adults.

  8. Change in the sleep quality to be evaluated by Pittsburgh Sleep Quality Index.

    Time frame: Baseline and at the end of 8 weeks.

    The Pittsburgh Sleep Quality Index, a self-administered questionnaire, includes four open-ended questions and 14 questions to be answered using event-frequency and semantic scales. The tool looks at seven areas; subjective sleep quality, sleep latency (the time it takes to fall asleep), sleep duration, habitual sleep efficiency (the ratio of total sleep time to time in bed), sleep disturbances, the use of sleep-promoting medication, and daytime dysfunction.

  9. Change in the anxiety level to be evaluated by Hospital Anxiety and Depression Scale (HADS) .

    Time frame: Baseline and at the end of 8 weeks.

    The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measureanxiety and depression (7 items for each subscale). Thetotal score is the sum of the 14 items, and for each sub-scale the score is the sum of the respective seven items(ranging from 0-21).

Sponsors and collaborators

Lead sponsor

Eastern Mediterranean University

Other

Registry information

Official study title

Effects of Reformer Pilates Exercise Training in Overweight and Obese Women

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 4, 2022
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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