Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000114842
Ethics application status
Approved
Date submitted
20/12/2019
Date registered
4/02/2021
Date last updated
4/02/2021
Date data sharing statement initially provided
4/02/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the effectiveness of whole body vibration training in healthy untrained females
Scientific title
Effects of 12-week Whole Body Vibration (WBV) training on hemorheological parameters, indicators of oxidative stress, bone turnover and endothelial functions markers, cognitive abilities and lower limb explosive performance capacity in healthy untrained women.
Secondary ID [1] 297578 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Musculoskeletal function 311835 0
Hemorheological properties of blood 316164 0
Cognitive function 316165 0
Condition category
Condition code
Musculoskeletal 310433 310433 0 0
Normal musculoskeletal and cartilage development and function
Blood 314459 314459 0 0
Normal development and function of platelets and erythrocytes
Mental Health 314460 314460 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study was attended by female students of the University of Physical Education in Krakow aged 19 to 25. There were 3 study groups: interventional and 2 active control groups. Allocation of subjects into different groups was done through volunteer sampling - the participants were recruited via posted advertisement at the university and assigned to the group to which they volunteered. Women from the interventional group took part in 36 individual training sessions on the vibrating platform (3 times a week for 3 months). Wole body vibration (WBV) training was carried out using the Fitvibe Excel Pro vibrating platform (Germany), which generates vertical vibrations with a frequency in the range of 20-60 Hz and an amplitude of 2 and 4 mm. The training protocol included warm-up, the main part consisting of static and dynamic exercises, and calming exercises at the end of the workout. Warm up included 6 modified jumping jacks, 3 hip circles in both directions, 6 lunges (3 for each leg). Static exercises included holding a standing position, holding a squat position, holding a strap in a standing position with shoulders raised. Dynamic exercises included deep squats, split squats for each leg. Calming exercises comprised of upward facing dog yoga pose and rolling like a ball. The duration of a single exercise on vibration platform was 1 minute. Between each exercise there was a 1-minute break during which women walked around the room. During dynamic squats the pace was 25 movements per minute (metronome was used). The vibration amplitude (2 mm) as well as the duration of exercises and breaks between them did not change throughout the whole duration of the training cycle. During the first 12 training sessions, the vibration frequency was 40 Hz, then increased by 5 Hz after 12 consecutive sessions (40-45-50 Hz). All trainings were supervised by a physiotherapist or a trained person and were conducted individually. To assess adherence to the intervention a session attendance checklist was used. The intervention took place at University of Physical Education in Krakow in a specially prepared room where the vibrating platform was located. This room had the same temperature and humidity during the whole training cycle.
Intervention code [1] 313811 0
Treatment: Devices
Comparator / control treatment
There were 2 active control groups. One group followed the same training protocol as the interventional group but without vibrating platform. The other control group performed no exercises at all and didn't attend any sessions, apart from 2 appointments (at the beginning and the end of the research period) for evaluation of studied indicators.
Control group
Active

Outcomes
Primary outcome [1] 319338 0
Assessment of changes in rheological properties of blood such as the erythrocyte elongation index (EI), erythrocyte aggregation indexes (AI), i.e. AMP - total aggregation, T1/2 - half time of total aggregation and fibrinogen which were determined using Analizator Laser-assisted Optical Rotational Cell Analyser (LORCA) RR Mechatronics.
Timepoint [1] 319338 0
Baseline, after 1 WBV (whole body vibration) training, before last WBV training and after last WBV training (12 weeks after intervention commencement)
Primary outcome [2] 319339 0
Assessment of lower limb explosive performance capacity using a dynamometric platform (AMTI)
Timepoint [2] 319339 0
Baseline, 12 weeks after intervention commencement
Primary outcome [3] 319340 0
Assessment of the basic plasma level of brain-derived neurotrophic factor (BDNF) in blood serum by enzyme-linked immunosorbent method (ELISA) using high-sensitivity reagent kits from DRG Instruments Gmbh (Germany) and SunRed Bio (China).
Timepoint [3] 319340 0
Baseline, after 1 WBV (whole body vibration) training, before last WBV training and after last WBV training (12 weeks after intervention commencement)
Secondary outcome [1] 367837 0
Evaluation of changes in bone turnover markers (PINP - N-Terminal, Propeptide of Type I Collagen and CTx - Serum C-telopeptide) in blood serum by enzyme-linked immunosorbent method (ELISA) using high-sensitivity reagent kits from DRG Instruments Gmbh (Germany) and SunRed Bio (China).
Timepoint [1] 367837 0
Baseline, after 12 weeks after intervention commencement.
Secondary outcome [2] 367840 0
Evaluation of changes in levels of oxidative stress markers: total antioxidative status/capacity - ImAnOx (TAS/TAC), Total Oxidative Status (TOS) in blood serum by enzyme-linked immunosorbent method (ELISA) using high-sensitivity reagent kits from DRG Instruments Gmbh (Germany) and SunRed Bio (China).
Timepoint [2] 367840 0
Baseline, after 1 WBV (whole body vibration) training, before last WBV training and after last WBV training (12 weeks after intervention commencement)
Secondary outcome [3] 367841 0
Assessment of peripheral blood pressure using digital blood pressure cuff
Timepoint [3] 367841 0
Interventional and active control groups were assessed before and after every WBV training. No treatment group was assessed at the beginning and the end of the research period.
Secondary outcome [4] 367890 0
Assessment of body mass composition (Bioelectrical Impedance Analysis - BIA)
Timepoint [4] 367890 0
Baseline and 12 weeks after intervention commencement
Secondary outcome [5] 378244 0
Assessment of cognitive abilities using Stroop Test
Timepoint [5] 378244 0
Baseline, after 12 weeks after intervention commencement
Secondary outcome [6] 379792 0
Assessment of hematological parameters of the blood: Hemoglobin, g/dL; Hematocrit, %; Erythrocytes (x1012/L); Leukocyte count (x109/L); Platelet count (x109/L)
Timepoint [6] 379792 0
Baseline, 12 weeks after intervention commencement
Secondary outcome [7] 379793 0
Evaluation of changes in the level of calcidiol (D-OH 25) in blood serum by enzyme-linked immunosorbent method (ELISA) using high-sensitivity reagent kits from DRG Instruments Gmbh (Germany) and SunRed Bio (China).
Timepoint [7] 379793 0
Baseline, after 12 weeks after intervention commencement
Secondary outcome [8] 379794 0
Assessment of selected body circumference (in a standing position using a nonstretchable measuring tape)
Timepoint [8] 379794 0
Baseline and 12 weeks after intervention commencement
Secondary outcome [9] 379795 0
Assessment of the level of Insulin-like growth factor 1 (IGF-1) in blood serum by enzyme-linked immunosorbent method (ELISA) using high-sensitivity reagent kits from DRG Instruments Gmbh (Germany) and SunRed Bio (China).
Timepoint [9] 379795 0
Baseline, after 1 WBV (whole body vibration) training, before last WBV training and after last WBV training (12 weeks after intervention commencement)
Secondary outcome [10] 379796 0
Assessment of the level of cortisol in blood serum by enzyme-linked immunosorbent method (ELISA) using high-sensitivity reagent kits from DRG Instruments Gmbh (Germany) and SunRed Bio (China).
Timepoint [10] 379796 0
Baseline, after 1 WBV (whole body vibration) training, before last WBV training and after last WBV training (12 weeks after intervention commencement)
Secondary outcome [11] 379797 0
Evaluation of changes in levels of tissue damage markers (8-hydroxy-2'-deoxyguanosine (8-OHdG), myoglobin) in blood serum by enzyme-linked immunosorbent method (ELISA) using high-sensitivity reagent kits from DRG Instruments Gmbh (Germany) and SunRed Bio (China).
Timepoint [11] 379797 0
Baseline, after 1 WBV (whole body vibration) training, before last WBV training and after last WBV training (12 weeks after intervention commencement)
Secondary outcome [12] 379798 0
Evaluation of changes in the level of inflammatory marker (High-sensitivity C-reactive Protein, hsCRP) in blood serum performed by immunoturbidimetry using a Cobas c 502 analyzer (Roche Diagnostics, USA).
Timepoint [12] 379798 0
Baseline, after 1 WBV (whole body vibration) training, before last WBV training and after last WBV training (12 weeks after intervention commencement)
Secondary outcome [13] 379799 0
Evaluation of changes in levels of endothelial function markers (Vascular Endothelial Growth Factor - VEGF, nitric oxide synthase 3 - eNOS) in blood serum by enzyme-linked immunosorbent method (ELISA) using high-sensitivity reagent kits from DRG Instruments Gmbh (Germany) and SunRed Bio (China).
Timepoint [13] 379799 0
Baseline, after 1 WBV (whole body vibration) training, before last WBV training and after last WBV training (12 weeks after intervention commencement)

Eligibility
Key inclusion criteria
No contraindications to whole body vibration training
Female aged 18-25
Non-training people or with low level of physical activity
Similar eating habits
BMI 18,5–24,99
Giving informed written consent
Minimum age
18 Years
Maximum age
25 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Lack of logical contact with the patient
Declaration of undertaking increased physical activity within 1 month before starting the study
Smoking tobacco
Regular intake of antioxidant vitamins and other dietary supplements at least 1 month before the start of the study
Use of hormonal contraceptives
Diagnosed with polycystic ovary syndrome or anovulatory cycles
Pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
6/02/2017
Date of last participant enrolment
Anticipated
Actual
12/03/2018
Date of last data collection
Anticipated
Actual
28/06/2018
Sample size
Target
50
Accrual to date
Final
46
Recruitment outside Australia
Country [1] 22103 0
Poland
State/province [1] 22103 0

Funding & Sponsors
Funding source category [1] 302126 0
University
Name [1] 302126 0
Univeristy of Physical Education in Cracow
Country [1] 302126 0
Poland
Primary sponsor type
Individual
Name
Halina Gattner
Address
University of Physical Education in Cracow
Doctoral Studies at the Physiotherapy Department
al. Jana Pawla II 78
31-571 Kraków
Country
Poland
Secondary sponsor category [1] 301963 0
Individual
Name [1] 301963 0
Justyna Adamiak
Address [1] 301963 0
University of Physical Education in Cracow
Physiotherapy Department
al. Jana Pawla II 78
31-571 Kraków
Country [1] 301963 0
Poland
Secondary sponsor category [2] 304493 0
Individual
Name [2] 304493 0
Anna Piotrowska
Address [2] 304493 0
University of Physical Education in Cracow
Physiotherapy Department
al. Jana Pawla II 78
31-571 Kraków
Country [2] 304493 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302807 0
Komisja Bioetyczna przy Okregowej Izbie Lekarskiej w Krakowie
Ethics committee address [1] 302807 0
Ethics committee country [1] 302807 0
Poland
Date submitted for ethics approval [1] 302807 0
Approval date [1] 302807 0
12/12/2016
Ethics approval number [1] 302807 0
Nr 224/KBL/OIL/2016

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91466 0
Mrs Halina Gattner
Address 91466 0
University of Physical Education in Cracow
Doctoral Studies at the Physiotherapy Department
al. Jana Pawla II 78
31-571 Kraków
Country 91466 0
Poland
Phone 91466 0
+48669157451
Fax 91466 0
Email 91466 0
[email protected]
Contact person for public queries
Name 91467 0
Justyna Adamiak
Address 91467 0
University of Physical Education in Cracow
Physiotherapy Department
al. Jana Pawla II 78
31-571 Kraków
Country 91467 0
Poland
Phone 91467 0
+48502262630
Fax 91467 0
Email 91467 0
[email protected]
Contact person for scientific queries
Name 91468 0
Halina Gattner
Address 91468 0
University of Physical Education in Cracow
Doctoral Studies at the Physiotherapy Department
al. Jana Pawla II 78
31-571 Kraków
Country 91468 0
Poland
Phone 91468 0
+48669157451
Fax 91468 0
Email 91468 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffect of Whole-Body Vibration on Serum Levels of Brain Derived Neurotrophic Factor and Cortisol in Young, Healthy Women.2022https://dx.doi.org/10.3390/ijerph192316108
EmbaseEffect of Whole-Body Vibration Training on Hemorheological Blood Indices in Young, Healthy Women.2023https://dx.doi.org/10.3390/ijerph20043232
N.B. These documents automatically identified may not have been verified by the study sponsor.