Healthy LifestyleNCT04490577
Whole-Body Vibration Training and Pilates Exercises for Healthy Women
A study testing Pilates exercises and Whole body vibration in people with Healthy Lifestyle and Body Weight, run by Baskent University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Lifestyle, Body Weight, Fatigue
- What is being tested?
- Pilates exercises and Whole body vibration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Aug 2018to 10 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Healthy Lifestyle, Body Weight, Fatigue
- Being tested
- Pilates exercises, Whole body vibration
- Keywords
- exercise, Physical fitness, Health
- Medical subject headings
- Body Weight, Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates exercisesOther
Pilates exercises are a combined exercise procedure including strengthening and stretching. Pilates exercises are performed with different equipment for example; therabands, mats, reformer, etc.
Whole body vibrationOther
Whole-body vibration gives vibration to the body with a platform at different frequencies (Power-plate). The participant performed exercises on the platform.
| Study group | Role | What they receive |
|---|---|---|
| Pilates training group | Experimental | In the Pilates group, the exercises were performed with "Reformer®" for eight weeks, twice in a week, one hour per day. Receives: Other: Pilates exercises |
| Whole-body vibration (WBV) group | Experimental | In the WBV group, the training was given "Power Plate®" for eight weeks, twice in a week, and 30 minutes in a day. Receives: Other: Whole body vibration |
| Control group | No intervention | The control group did not receive any training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-intervention and immediately after the intervention
Secondary outcomes (13)
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.
Measured: Pre-intervention and immediately after the intervention
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.
Measured: Pre-intervention and immediately after the intervention
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.
Measured: Pre-intervention and immediately after the intervention
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.
Measured: Pre-intervention and immediately after the intervention
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.
Measured: Pre-intervention and immediately after the intervention
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.
Measured: Pre-intervention and immediately after the intervention
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.
Measured: Pre-intervention and immediately after the intervention
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.
Measured: Pre-intervention and immediately after the intervention
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.
Measured: Pre-intervention and immediately after the intervention
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.
Measured: Pre-intervention and immediately after the intervention
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.
Measured: Pre-intervention and immediately after the intervention
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.
Measured: Pre-intervention and immediately after the intervention
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.
Measured: Pre-intervention and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start20 Aug 2018
- Primary completion10 Jan 2019
- Study completion10 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy LifestyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The 36 healthy participants divided into three groups.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Yuruk, Baskent University
- Investigators
- Ozlem Yuruk, Assoc. Prof., Study director, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04490577
- Sponsor's protocol ID
- KA18/268
- Status last verified
- Jul 2020
- First submitted
- 7 Jul 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04490577
- Acronym / sponsor ID
- KA18/268
- Conditions
- Healthy Lifestyle, Body Weight, Fatigue
- Keywords
- exercise, Physical fitness, Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 10 Jan 2019 (actual)
- Study completion
- 10 Jan 2019 (actual)
- First posted
- 29 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The 36 healthy participants divided into three groups.
| Arm | Type | Receives |
|---|---|---|
| Pilates training group | Experimental | Other: Pilates exercisesIn the Pilates group, the exercises were performed with "Reformer®" for eight weeks, twice in a week, one hour per day. |
| Whole-body vibration (WBV) group | Experimental | Other: Whole body vibrationIn the WBV group, the training was given "Power Plate®" for eight weeks, twice in a week, and 30 minutes in a day. |
| Control group | No intervention | –The control group did not receive any training. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilates exercisesPilates exercises are a combined exercise procedure including strengthening and stretching. Pilates exercises are performed with different equipment for example; therabands, mats, reformer, etc. | Other | Pilates training group |
| Whole body vibrationWhole-body vibration gives vibration to the body with a platform at different frequencies (Power-plate). The participant performed exercises on the platform. | Other | Whole-body vibration (WBV) group |
Primary outcome
Body Composition Change
Time frame: Pre-intervention and immediately after the intervention
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.
13 secondary outcomes
Body Mass Index
Time frame: Pre-intervention and immediately after the intervention
Waist-hip ratio
Time frame: Pre-intervention and immediately after the intervention
Aerobic capacity
Time frame: Pre-intervention and immediately after the intervention
Flexibility
Time frame: Pre-intervention and immediately after the intervention
Balance
Time frame: Pre-intervention and immediately after the intervention
Physical Self-Perception
Time frame: Pre-intervention and immediately after the intervention
Fatigue Severity Scale
Time frame: Pre-intervention and immediately after the intervention
Lateral Bridge test
Time frame: Pre-intervention and immediately after the intervention
Modified Biering-Sorensen test
Time frame: Pre-intervention and immediately after the intervention
Trunk flexion test
Time frame: Pre-intervention and immediately after the intervention
Prone bridge test
Time frame: Pre-intervention and immediately after the intervention
Sit-ups test
Time frame: Pre-intervention and immediately after the intervention
Modified push-up test
Time frame: Pre-intervention and immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ozlem Yuruk, Assoc. Prof. study director
Baskent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates exercises and Whole body vibration in people with Healthy Lifestyle and Body Weight, run by Baskent University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Composition Change (time frame: Pre-intervention and immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.