Effects of Reformer Pilates Exercise Training

Physical Performance Clinical Trial

Official title:

Effects of Reformer Pilates Exercise Training in Overweight and Obese Women

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05176912
• Other study ID #: 2021/02
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 3, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: December 2021
• Source: Eastern Mediterranean University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 47
• Est. completion date: December 1, 2022
• Est. primary completion date: July 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Physical Performance

Intervention

Other:
• Exercise
Reformer Pilates exercises will given for 8 weeks, 3 days in a week

Locations

Country	Name	City	State
Cyprus	Eastern Mediterranean University	Famagusta

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Mediterranean University

Country where clinical trial is conducted

Cyprus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in the level of trunk flexor muscle endurance to be evaluated by a McGill core endurance tests.	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.	Baseline and at the end of 8 weeks.
Other	Change in the level of back extensors muscle endurance to be evaluated by a McGill core endurance tests.	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.	Baseline and at the end of 8 weeks.
Other	Change in the level of lateral muscle endurance to be evaluated by a McGill core endurance tests.	The lateral muscle is tested with the person lying in the full side-bridge position.	Baseline and at the end of 8 weeks.
Other	Change in the strength of the back to be evaluated by back dynamometer.	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.	Baseline and at the end of 8 weeks.
Other	Change in the strength of the abdominal muscle to be evaluated by sit-up test.	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.	Baseline and at the end of 8 weeks.
Other	Change in the endurance of the lower extremity to be evaluated by 30 second sit and stand test.	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.	Baseline and at the end of 8 weeks.
Other	Change in the balance to be evaluated by Fullerton Advanced Balance Scale.	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.	Baseline and at the end of 8 weeks.
Other	Change in the sleep quality to be evaluated by Pittsburgh Sleep Quality Index.	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.	Baseline and at the end of 8 weeks.
Other	Change in the anxiety level to be evaluated by Hospital Anxiety and Depression Scale (HADS) .	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).	Baseline and at the end of 8 weeks.
Primary	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	Change in the level of upper extremity strength to be evaluated by a hand grip dynamometer.	The subject sits upright in a supported chair and on a flat surface. The person is prepared with the knee and hip in 90° flexion, forearm in neutral position and wrist in 0-30° extension. During the measurement, the person whose grip strength is measured is asked to squeeze the arms of the dynamometer strongly.	Baseline and at the end of 8 weeks.