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Whole-Body Vibration Training and Pilates Exercises for Healthy Women

Primary Purpose

Healthy Lifestyle, Body Weight, Fatigue

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pilates exercises
Whole body vibration
Sponsored by
Baskent University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthy Lifestyle focused on measuring exercise, Physical fitness, Health

Eligibility Criteria

25 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Individuals have not been exercising regularly in the last six months
  • Physical activity level was between 600-3000 MET min/week (Metabolic equivalent minutes/week) according to the result of the "International Physical Activity Questionnaire"
  • Bodyweight of less than 130 kg Individuals.

Exclusion Criteria:

  • History of malignancy
  • Pregnant individuals
  • Musculoskeletal pain due to orthopedic or rheumatic diseases
  • History of fractures in the past year
  • Neurological disease (stroke, epilepsy, etc.)
  • Chronic kidney or liver disease, cardiovascular diseases (cardiac arrhythmia, cardiac insufficiency, etc.)
  • Imbalance due to peripheral vestibular disorder diagnosis (Benign paroxysmal positional vertigo, Meniere's disease, etc.)
  • Individuals who not be able to tolerate vibration for more than five minutes were not included in the study

Sites / Locations

  • Baskent University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Pilates training group

Whole-body vibration (WBV) group

Control group

Arm Description

In the Pilates group, the exercises were performed with "Reformer®" for eight weeks, twice in a week, one hour per day.

In the WBV group, the training was given "Power Plate®" for eight weeks, twice in a week, and 30 minutes in a day.

The control group did not receive any training.

Outcomes

Primary Outcome Measures

Body Composition Change
The body composition of the subjects was evaluated with bioelectrical impedance analysis (Tanita BC 601,Tanita Corp., Maeno-Cho, Tokyo, Japan). Body fat proportion was recorded as a percentage.

Secondary Outcome Measures

Body Mass Index
The body composition of the subjects was evaluated with body mass index (BMI). The BMI is a person's weight in kilograms divided by the square of height in meters. A high BMI can be an indicator of high body fatness.
Waist-hip ratio
The body composition of the subjects was also evaluated with waist-hip ratio. The waist to hip ratio measurement is calculated by dividing the measurement of your waist by your hip measurement. The score recorded as centimeter.
Aerobic capacity
The aerobic capacity of the participants was evaluated with Shuttle-run test. Shuttle run test involve repetitive running back and forth, either over the same distance, or with changing distances. The shorter trial recorded as seconds.
Flexibility
The sit and reach test used for flexibility. Sit and reach test measures measures the flexibility of the lower back and hamstring muscles.The score is recorded to the nearest centimeter as the distance reached by the hand.
Balance
The balance was evaluated by Functional reach test. The test evaluated dynamic balance and limit of stability. This test measures the distance between the length of an outstretched arm in a maximal forward reach from a standing position,while maintaining a fixed base of support. The score recorded as centimeter. Higher scores indicate good level of balance.
Physical Self-Perception
Physical self-perception was assessed with Physical Self Perception Profile. The questionnaire has four subdomain subscales designed to assess perceived bodily attractiveness, sports competence, physical strength, and physical conditioning were constructed along with a general physical self-worth subscale as the basis of the Physical Self-Perception Profile.
Fatigue Severity Scale
The 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle. Each item consists of statements that are scored on a seven-point Likert type scale ranging from 1 ("strongly disagree") to 7 ("strongly agree"). The higher scores indicates severe fatigue.
Lateral Bridge test
Lateral bridge test involves static, isometric contractions of the lateral muscles on each side of the trunk that stabilize the spine. The score recorded as second. Higher scores indicate good level of endurance.
Modified Biering-Sorensen test
Modified Biering-Sorensen test measuring how many seconds the subject is able to keep the unsupported upper body (from the upper border of the iliac crest) horizontal, while placed prone with the buttocks and legs fixed to the couch by three wide canvas straps and the arms folded across the chest. The score recorded as second. Higher scores indicate good level of endurance.
Trunk flexion test
Trunk flexion test involving a static, isometric contraction of the anterior muscles, stabilizing the spine until the individual exhibits fatigue and can no longer hold the assumed position. The score recorded as second. Higher scores indicate good level of endurance.
Prone bridge test
The prone bridge test measures the muscular endurance of the abdominal muscles.The score recorded as second. Higher scores indicate good level of endurance.
Sit-ups test
The sit-ups test is a measure the endurance of the abdominal and hip-flexor muscles. The aim of this test is to perform as many sit-ups as you can in two minutes.
Modified push-up test
The modified push-up test was used to measure upper body strength endurance and trunk stability. This variation, which uses a modified technique with a clap behind the back while in the 'down' position and a touch from one hand to the other in the 'up' position.The total number of correctly completed push-ups were recorded.

Full Information

First Posted
July 7, 2020
Last Updated
July 24, 2020
Sponsor
Baskent University
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1. Study Identification

Unique Protocol Identification Number
NCT04490577
Brief Title
Whole-Body Vibration Training and Pilates Exercises for Healthy Women
Official Title
Comparison of the Effects of Whole-Body Vibration Training and Pilates Exercises on Physical Fitness, Fatigue and Physical Self Perception in Healthy Women
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
August 20, 2018 (Actual)
Primary Completion Date
January 10, 2019 (Actual)
Study Completion Date
January 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aimed to compare the effects of whole-body vibration (WBV) training and Pilates exercises on physical fitness, fatigue, and physical self-perception in healthy women. This study was carried out on 36 healthy sedentary female subjects. Subjects were divided into three groups; Pilates training group, WBV training group, and control group. In the Pilates group, the exercises were performed with "Reformer®" for eight weeks, twice in a week, 45-min per day. In the WBV group, the training was given "Power Plate®" for eight weeks, twice in a week, and 30 minutes in a day. The control group did not receive any training.
Detailed Description
This study aimed to compare the effects of whole-body vibration (WBV) training and Pilates exercises on physical fitness, fatigue, and physical self-perception in healthy women aged between 25-45 years. The study was conducted between August 2018-January 2019 in a health and physiotherapy clinic. This study was carried out on 36 healthy sedantary female subjects. Before starting the study, the subjects were divided into three groups in a randomized manner using "Random Online Allocation Software" (www.Graphpad.com) Group 1: Pilates training group Group 2: WBV training group Group 3: Control group Pilates training group: The exercises were performed with "Reformer®" for eight weeks, twice in a week, 45-min per day. Warm-up and cool-down exercises were performed before and after the training. WBV training group: The training was given "Power Plate®" for eight weeks, twice in a week, and 30 minutes in a day. Warm-up and cool-down exercises were performed before and after the training. Control group: The control group did not receive any training. The body composition of the subjects was evaluated with body mass index, waist-hip ratio and bioelectrical impedance analysis; functional capacity with Shuttle Run Test; core endurance with lateral bridge test, modified Biering-Sorensen test, trunk flexion test and prone bridge test and functional core strength with sit-ups and modified push-up tests. The stability of the core muscles was also measured with a pressure biofeedback instrument. The Sit and Reach test was used to assess flexibility and the Functional Reach Test was used for balance. Fatigue was evaluated with The Fatigue Severity Scale and physical self-perception was assessed with the Physical Self Perception Profile. The subjects were evaluated pre-intervention and immediately after the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Lifestyle, Body Weight, Fatigue
Keywords
exercise, Physical fitness, Health

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
The 36 healthy participants divided into three groups.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pilates training group
Arm Type
Experimental
Arm Description
In the Pilates group, the exercises were performed with "Reformer®" for eight weeks, twice in a week, one hour per day.
Arm Title
Whole-body vibration (WBV) group
Arm Type
Experimental
Arm Description
In the WBV group, the training was given "Power Plate®" for eight weeks, twice in a week, and 30 minutes in a day.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group did not receive any training.
Intervention Type
Other
Intervention Name(s)
Pilates exercises
Intervention Description
Pilates exercises are a combined exercise procedure including strengthening and stretching. Pilates exercises are performed with different equipment for example; therabands, mats, reformer, etc.
Intervention Type
Other
Intervention Name(s)
Whole body vibration
Intervention Description
Whole-body vibration gives vibration to the body with a platform at different frequencies (Power-plate). The participant performed exercises on the platform.
Primary Outcome Measure Information:
Title
Body Composition Change
Description
The body composition of the subjects was evaluated with bioelectrical impedance analysis (Tanita BC 601,Tanita Corp., Maeno-Cho, Tokyo, Japan). Body fat proportion was recorded as a percentage.
Time Frame
Pre-intervention and immediately after the intervention
Secondary Outcome Measure Information:
Title
Body Mass Index
Description
The body composition of the subjects was evaluated with body mass index (BMI). The BMI is a person's weight in kilograms divided by the square of height in meters. A high BMI can be an indicator of high body fatness.
Time Frame
Pre-intervention and immediately after the intervention
Title
Waist-hip ratio
Description
The body composition of the subjects was also evaluated with waist-hip ratio. The waist to hip ratio measurement is calculated by dividing the measurement of your waist by your hip measurement. The score recorded as centimeter.
Time Frame
Pre-intervention and immediately after the intervention
Title
Aerobic capacity
Description
The aerobic capacity of the participants was evaluated with Shuttle-run test. Shuttle run test involve repetitive running back and forth, either over the same distance, or with changing distances. The shorter trial recorded as seconds.
Time Frame
Pre-intervention and immediately after the intervention
Title
Flexibility
Description
The sit and reach test used for flexibility. Sit and reach test measures measures the flexibility of the lower back and hamstring muscles.The score is recorded to the nearest centimeter as the distance reached by the hand.
Time Frame
Pre-intervention and immediately after the intervention
Title
Balance
Description
The balance was evaluated by Functional reach test. The test evaluated dynamic balance and limit of stability. This test measures the distance between the length of an outstretched arm in a maximal forward reach from a standing position,while maintaining a fixed base of support. The score recorded as centimeter. Higher scores indicate good level of balance.
Time Frame
Pre-intervention and immediately after the intervention
Title
Physical Self-Perception
Description
Physical self-perception was assessed with Physical Self Perception Profile. The questionnaire has four subdomain subscales designed to assess perceived bodily attractiveness, sports competence, physical strength, and physical conditioning were constructed along with a general physical self-worth subscale as the basis of the Physical Self-Perception Profile.
Time Frame
Pre-intervention and immediately after the intervention
Title
Fatigue Severity Scale
Description
The 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle. Each item consists of statements that are scored on a seven-point Likert type scale ranging from 1 ("strongly disagree") to 7 ("strongly agree"). The higher scores indicates severe fatigue.
Time Frame
Pre-intervention and immediately after the intervention
Title
Lateral Bridge test
Description
Lateral bridge test involves static, isometric contractions of the lateral muscles on each side of the trunk that stabilize the spine. The score recorded as second. Higher scores indicate good level of endurance.
Time Frame
Pre-intervention and immediately after the intervention
Title
Modified Biering-Sorensen test
Description
Modified Biering-Sorensen test measuring how many seconds the subject is able to keep the unsupported upper body (from the upper border of the iliac crest) horizontal, while placed prone with the buttocks and legs fixed to the couch by three wide canvas straps and the arms folded across the chest. The score recorded as second. Higher scores indicate good level of endurance.
Time Frame
Pre-intervention and immediately after the intervention
Title
Trunk flexion test
Description
Trunk flexion test involving a static, isometric contraction of the anterior muscles, stabilizing the spine until the individual exhibits fatigue and can no longer hold the assumed position. The score recorded as second. Higher scores indicate good level of endurance.
Time Frame
Pre-intervention and immediately after the intervention
Title
Prone bridge test
Description
The prone bridge test measures the muscular endurance of the abdominal muscles.The score recorded as second. Higher scores indicate good level of endurance.
Time Frame
Pre-intervention and immediately after the intervention
Title
Sit-ups test
Description
The sit-ups test is a measure the endurance of the abdominal and hip-flexor muscles. The aim of this test is to perform as many sit-ups as you can in two minutes.
Time Frame
Pre-intervention and immediately after the intervention
Title
Modified push-up test
Description
The modified push-up test was used to measure upper body strength endurance and trunk stability. This variation, which uses a modified technique with a clap behind the back while in the 'down' position and a touch from one hand to the other in the 'up' position.The total number of correctly completed push-ups were recorded.
Time Frame
Pre-intervention and immediately after the intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Individuals have not been exercising regularly in the last six months Physical activity level was between 600-3000 MET min/week (Metabolic equivalent minutes/week) according to the result of the "International Physical Activity Questionnaire" Bodyweight of less than 130 kg Individuals. Exclusion Criteria: History of malignancy Pregnant individuals Musculoskeletal pain due to orthopedic or rheumatic diseases History of fractures in the past year Neurological disease (stroke, epilepsy, etc.) Chronic kidney or liver disease, cardiovascular diseases (cardiac arrhythmia, cardiac insufficiency, etc.) Imbalance due to peripheral vestibular disorder diagnosis (Benign paroxysmal positional vertigo, Meniere's disease, etc.) Individuals who not be able to tolerate vibration for more than five minutes were not included in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ozlem Yuruk, Assoc. Prof.
Organizational Affiliation
Baskent University
Official's Role
Study Director
Facility Information:
Facility Name
Baskent University
City
Ankara
ZIP/Postal Code
06810
Country
Turkey

12. IPD Sharing Statement

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Whole-Body Vibration Training and Pilates Exercises for Healthy Women

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