NCT05571020

Brief Summary

The aim of this study is to investigate Mat Pilates exercise on the musculoskeletal system, body composition, and psychosocial status, Fatigue, SeverityScale, sleep quality, mood disorder. Method: Participants were randomly divided into two groups as Mat-PilatesGroup (n=16) and Control Group (n=16). Mat-PilatesGroup participants were given Mat Pilates exercise for about 1 hour per day, twice a week for 8 weeks, accompanied by a physiotherapist. Control Group participants did not participate in any exercise program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2022

Completed
Last Updated

October 12, 2022

Status Verified

October 1, 2022

Enrollment Period

4 months

First QC Date

October 3, 2022

Last Update Submit

October 7, 2022

Conditions

Outcome Measures

Primary Outcomes (18)

  • weight in kilograms

    evaluated with a bioelectrical impedance analyzer (Tanita RD-545)

    Change from Baseline weight in kilograms at 2 months

  • height in meters

    The height of the participants was measured using a fixed stadiometer with 0.5 cm precision.While the person is standing during the measurement; Measurements were taken without shoes, head upright, feet touching the wall with heels together, knees tense, body upright and head in Frankfort plane.

    2 months

  • waist circumference measurement

    Individuals were asked to stand with arms outstretched and feet together, and measurements were taken from the narrowest part of the trunk. Since it is difficult to determine the narrowest part of the trunk in obese individuals, the evaluation was made from the midpoint between the ribs and the iliac crest.

    Change from Baseline waist circumference measurement at 2 months

  • hip circumference measurement

    The widest protrusion level of the hip muscles was measured at the level of the symphysis pubis anteriorly and in the posterior region.

    Change from Baseline hip circumference measurement at 2 months

  • waist/hip ratio circumference measurement

    It was calculated by dividing the waist circumference (cm) of the individuals by the hip circumference (cm). Waist/hip Ratio is the most commonly used anthropometric method to determine fat distribution. While waist circumference of 90 cm and above determines the risk increase in men, this measurement is 80 cm and above in women. Waist circumference of 102 cm or more in men and 88 cm or more in women indicates a significant increased risk for coronary heart disease and metabolic complications.

    hange from Baseline waist/hip ratio circumference measurement at 2 months

  • Body Mass Index

    weight and height will be combined to report BMI in kg/m\^2)

    Change from Baseline Body Mass Index at 2 months

  • Body Fat Ratio

    evaluated with a bioelectrical impedance analyzer (Tanita RD-545)

    Change from Baseline Body Fat Ratio at 2 months

  • Fat Mass

    All carbohydrates, fats and proteins that are in excess of the need in the body turn into adipose tissue. A large part of this transformed warehouse is located under the skin, especially in the thigh, hip and chest area.

    Change from Baseline Fat Mass at 2 months

  • bilateral arm circumference measurement

    The midpoint between the acromion and the olecranon was found and marked on the arm. The individual was asked to stand and flex the elbow by contracting the biceps brachii muscle. Circumference measurement was taken from the widest part of the muscle.

    Change from Baseline bilateral arm circumference measurement at 2 months

  • leg circumference measurement

    The measurement was made in a standing position. Measurements were made at the midpoint between the inguinal region and the proximal part of the patella or where the muscle was most swollen. 10-15 cm above the patella corresponds to this point

    Change from Baseline bilateral leg circumference measurement at 2 months

  • Flexibility Assessment

    Trunk Flexion and Hamstring Length, Trunk Hyperextension, Trunk Lateral Flexion

    Change from Baseline Flexibility Assessment at 2 months

  • Psychosocial Status Assessment

    Quality of Life (Short Form) Scale: The scale includes a total of 36 items and 8 subsections to be answered considering the last four weeks. health status is evaluated between 0 and 100 points in total. 0 indicates worst health, 100 indicates best health.

    Change from Baseline Psychosocial Status Assessment at 2 months

  • Fatigue Severity

    Fatigue Severity Scale: The Turkish version of the Fatigue Severity Scale (ref) was used to evaluate the fatigue status of individuals. The scale assesses the state of fatigue in the last four weeks, including the day it was filled. Individuals score between 0 and 7 (for each question?) on the scale, which consists of 9 questions in total. High scores indicate increased fatigue

    Change from Baseline Fatigue Severity at 2 months

  • Sleep Quality

    Pittsburg Sleep Quality index: The Turkish version of the Pittsburg Sleep Quality Index (ref) was used for the quantitative evaluation of sleep quality. The scale consists of a total of 24 questions, 19 of which are self-report (self-report) questions and 5 of which are answered by the individual's spouse or roommate (these questions are not included in the calculation), and it evaluates the last one-month period. Self-assessment questions are related to sleep quality and do not indicate sleep disturbance and the prevalence of the disorder. The 18 items scored are grouped into seven component scores (subjective sleep quality, sleep delay, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping pills, daytime dysfunction). The total score of the seven components is equal to the total index score. Each item is scored between 0-3 and the total score varies between 0-21. A total score of five or more indicates poor sleep quality.

    Change from Baseline Sleep Quality at 2 months

  • Mood

    Beck Depression Inventory: Individuals' emotional states were evaluated with the Turkish version of the Beck Depression Inventory (ref). BDI is a self-assessment scale designed to define and measure the severity of depression in healthy individuals and psychiatric patient groups. It consists of 21 items in total and each item is scored between 0-3. A total is obtained by summing the scores of all items. A high total score indicates a high severity of depression. 0-9 points = no depression, 10-16 points = mild depression, 17-29 points = moderate depression, 30 and above = severe depression

    Change from Baseline Mood at 2 months

  • Trunk Flexibility Assesment

    For this test, individuals were asked to stand on a 15 cm high block, bend forward without bending their knees, and try to touch the tips of their toes. The distance between the fingertip and the block surface was measured with a tape measure and recorded in centimeters. With this test, flexibility of the lumbar region, hamstring and gastrocnemius muscles was evaluated.

    Change from Baseline Trunk Flexibility Assesment at 2 months

  • Trunk Hyperextension Flexibility Assesment

    In this test, the individual stood facing the wall, keeping his pelvis and trunk in contact with the wall. For the initial value, the distance between the wall and the sternal notch was measured. After the pelvis was stabilized by the evaluator, the individual was asked to do trunk extension. The distance between the sternal notch and the wall was re-measured, subtracting the initial value from this value, and the amount of movement was recorded in centimeters.

    Change from Baseline Trunk Hyperextension Flexibility Assesment at 2 months

  • Trunk Lateral Flexion Flexibility Assesment

    The test was performed standing with the arms by the body and the feet parallel to each other and the back against the wall. First, the place of the distal end of the middle finger of the right hand on the thigh was marked. Then, the subject was asked to lateral flex the trunk without taking his back away from the wall, while sliding his hand down on the thigh. At the last point reached, the place of the distal tip of the middle finger on the thigh was marked and the distance from the initial measurement point was measured. The same operations were repeated for the left side.

    Change from Baseline Trunk Lateral Flexion Flexibility Assesment at 2 months

Study Arms (2)

Mat Pilates Group

EXPERIMENTAL

Two days a week, approximately one hour a day, for a total of eight weeks, in groups of 5-6 people, they were included in the mat pilates exercise program. Before starting the exercise program, the study group participants were informed about the principles of the pilates working system (I am not sure if this statement is correct terminologically), the training program and the 5 key elements of the pilates approach, neutral spine (head-neck-shoulder-waist-abdominal placement), lumbopelvic stabilization, Informative training on scapular stabilization, focusing and breathing was given.

Other: mat pilates

Control Group

NO INTERVENTION

Control group participants did not participate in any exercise program.

Interventions

Both groups adapted for their rides by not participating in a different exercise and meal. In the study, they were not found in any store in the control groups. In the Mat-Pates Group, information about the 5 key elements of the study and pilates team, perspective (-neck-shoulder-waist-abdominal placement), lumbopel stabilization, scapular stabilization, review and information was covered. Then, in the study groups, it was purchased from groups of 5-6 people at most for one hour a day. In order to participate in all these application activities, he continues his life without participating in any evaluation.

Mat Pilates Group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female participants between the ages of 20-60,
  • volunteer to participate in the study, healthcare workers,
  • lack of habit of exercising regularly in participants,
  • Those who can regularly participate in the exercise program to be applied

You may not qualify if:

  • have a disease that may prevent them from exercising (cardiovascular, pulmonary and orthopedic),
  • having vision and/or hearing loss, pregnancy status,
  • a history of loss of balance due to loss of consciousness or dizziness,
  • balance disorder due to the diagnosis of peripheral vestibular disease,
  • having a pacemaker or metal implant in their body

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Bülent Ecevit University

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

Location

Related Publications (2)

  • Jago R, Jonker ML, Missaghian M, Baranowski T. Effect of 4 weeks of Pilates on the body composition of young girls. Prev Med. 2006 Mar;42(3):177-80. doi: 10.1016/j.ypmed.2005.11.010. Epub 2005 Dec 27.

    PMID: 16376979BACKGROUND
  • Vaquero-Cristobal R, Alacid F, Esparza-Ros F, Lopez-Plaza D, Muyor JM, Lopez-Minarro PA. The effects of a reformer Pilates program on body composition and morphological characteristics in active women after a detraining period. Women Health. 2016 Oct;56(7):784-806. doi: 10.1080/03630242.2015.1118723. Epub 2015 Nov 19.

    PMID: 26583914BACKGROUND

MeSH Terms

Conditions

Health BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associated professor

Study Record Dates

First Submitted

October 3, 2022

First Posted

October 7, 2022

Study Start

February 10, 2021

Primary Completion

June 10, 2021

Study Completion

October 10, 2021

Last Updated

October 12, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations