Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000255785
Ethics application status
Approved
Date submitted
23/09/2021
Date registered
11/02/2022
Date last updated
11/02/2022
Date data sharing statement initially provided
11/02/2022
Date results provided
11/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of vibrotherapy on body fatness and blood parameters in elderly adults
Scientific title
Effect of vibrotherapy on body composition, hemorheological and biochemical blood parameters in elderly adults
Secondary ID [1] 303407 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiovascular diseases 322737 0
metabolic syndrome 322738 0
overweight 322739 0
ageing 323743 0
Condition category
Condition code
Physical Medicine / Rehabilitation 320329 320329 0 0
Other physical medicine / rehabilitation
Metabolic and Endocrine 322262 322262 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The objective of this study is to investigate the impact of variable frequency, low amplitude cycloidal vibration therapy in elderly adults (aged 60-70) and to estimate the change in participants’ body composition, hematological, rheological, protein blood parameters and fibrinogen concentration.
The patients will receive vibrotherapy treatments 30 vibration therapies during three months, in the morning, once a day, five times a week. They will be obligated to participate in three courses while one course comprises ten vibration treatments and ten days of resting. One vibration treatment will last 29 minutes and include 8 microprograms. The treatments will be performed in a prone position with the use of the RAM Vitberg+ Base Module (active medical device, class IIa) enhanced with the module RAM Vitberg+ Metabolism (active medical device, class I). The whole RAM Vitberg+ system combines the general action following the WBV rule (Whole Body Vibration – oscillations of a general character) with local action applying additional therapeutical module in which the vibration impulse of RAM Vitberg+Metabolism is directed towards the areas of: epigastrium, mid-abdomen, pubic region, inguinal region, lateral and hypochondriac regions of abdomen, superficial fascia and the layer between subcutaneous tissue and abdominal muscles. The indexes of the applied vibration change in time according to the characteristics of the program. Each intervention is the same medical program written by the manufacturer of the medical device, which includes various frequencies and amplitudes that change over time during the intervention. The therapeutical stimulus consists of cycloid vibrations, produced in three perpendicular directions (3D), inducing intermittent pulsations with variable values of frequency (f), amplitude (A), and acceleration (a), that ranges between 25-52 Hz, 0.1-0.5 mm, and 6.9-13.5 m/s2, respectively.
All of the trainings will be carried out at the same time of day (in the morning) by the same, qualified physiotherapist (with minimum 5 years' experience), in a room with the same temperature and humidity. Each volunteer will be qualified by a physician before participation in the study. The session attendance checklists will be used to monitor adherence to the intervention. The therapy will take place at Physiotherapy Practice in Skawina, Poland and will be supervised by the members of the University of Physical Education in Krakow, Poland.
Intervention code [1] 321098 0
Rehabilitation
Intervention code [2] 321099 0
Treatment: Devices
Comparator / control treatment
A group without vibration therapy: the participants in the control group will not receive any treatments during this study and will be asked not to alter their nutritional habits, taken medicines, or level of physical activity during the experiment.
Control group
Active

Outcomes
Primary outcome [1] 328182 0
Influence of vibrotherapy treatment on the body composition (fat free mass (FFM) (kg), body fat mass (BF) (kg), percentage of body fat (BF) (%), total body water (TBW) (%)) assessed by the bioimpedance method.
Timepoint [1] 328182 0
Baseline, after 30th treatment (post-enrolment).
Primary outcome [2] 328183 0
Influence of vibrotherapy treatment on the complete blood count assessed as a composite of: hemoglobin (Hb) (g/dL), hematocrit (Hct) (%), red blood cells (RBC) (T/L), white blood cells (WBC) (109/L), platelets (PLT) (109/L), mean platelet volume (MPV) (fl), platelet distribution width (PDW) (%), plateletcrit (PCT) (%), mean corpuscular volume (MCV) (fl), mean corpuscular hemoglobin (MCH) (pg), mean corpuscular hemoglobin concentration (MCHC) (g/dL), red blood cell distribution width (RDW-CV) (%), and red blood cell distribution width, standard deviation (RDW-SD) (fl) assessed in blood sample with a hematology analyzer.
Timepoint [2] 328183 0
Baseline, after 30th treatment (post-enrolment).
Primary outcome [3] 328184 0
Influence of vibrotherapy treatment on fibrinogen (g/L) assessed in blood sample by spectrophotometric method.
Timepoint [3] 328184 0
Baseline, after 30th treatment (post-enrolment).
Secondary outcome [1] 397948 0
Influence of vibrotherapy treatment on the erythrocyte aggregation (assessed as a composite of aggregation index (AI) (%), total extent of aggregation (AMP, amplitude) (a.u.), half time kinetics of aggregation (T1/2) (s)), assessed in blood sample by a laser-optical rotational cell analyzer as primary outcome.
Timepoint [1] 397948 0
Baseline, after 30th treatment (post-enrolment) as primary timepoint.
Secondary outcome [2] 404630 0
Influence of vibrotherapy treatment on the protein values in the plasma (composite of proteins, albumins, alfa-1-globulins, alfa-2-globulins, ß-1-globulins, ß-2-globulins, gamma-globulins (g/L)) assessed by biuret method.
Timepoint [2] 404630 0
Baseline, after 30th treatment (post-enrolment).
Secondary outcome [3] 404631 0
Influence of vibrotherapy treatment on the level of quality of life assessed by 36-Item Short Form Health Survey (SF-36).
Timepoint [3] 404631 0
Baseline, after 30th treatment (post-enrolment).
Secondary outcome [4] 406176 0
Influence of vibrotherapy treatment on the body mass index (BMI) (kg/m2) assesed according to the following formula: BMI = weight (kg)/height2 (m2) as primary outcome. Height measured without shoes, in a standing position to the nearest 1 mm, with the head in the Frankfurt plane, using an anthropometer. Weight obtained in the standing position with a standardized medical scale, with an accuracy of 100 g.
Timepoint [4] 406176 0
Baseline, after 30th treatment (post-enrolment) as primary timepoint.

Eligibility
Key inclusion criteria
Age between 60 and 70, written consent to take part in the examinations, lack of contraindications for undertaking physical activity
Minimum age
60 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Lack of the consent to participate in the examinations, motion limitations that could make vibrotherapy impossible, advanced illnesses of blood vessels (aneurysm, thrombosis, ath-erosclerosis), conditions after recent heart attacks and strokes, conditions after bone frac-tures till complete adhesion, conditions after breaking tendons, ligaments and muscles till fully regenerated, after treatments: endoprosthesis, implantation, reconstruction and other surgeries till completely healed, acute infections caused by bacteria, fungi or viruses in-cluding skin infections, abscesses, non-controlled hypertension, advanced renal calculi and gallstones, acute condition of multiple sclerosis, epilepsy, illnesses with vertigo, in-sufficient mental fitness, syringomyelia, hemorrhage, increased body temperature, and active cancer.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Volunteers are randomly assigned to the groups: sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The distribution of results for the analyzed variables will be checked applying the Shapiro–Wilk test. For single measurements, the signifcance of group-related differences will be assessed using independent-sample tests, Student’s t-test or the Mann–Whitney U test. In vibration group (VG) and control group (CG) the values of differences will be assessed between the first and second examinations and the level of statistical significance will be estimated with the pairs order Wilcoxon test. Comparing the impact of vibration treatments on changes in the analyzed variables among the compared groups, the analysis of variance with repeated measures (ANOVA) will be used, examining the infuence of the main factors, i.e., Group (Vibration and Control), Treatment (infuence of Vibration Therapy) and Group × Treatment interaction for variables of normal distribution. The statistical signifcance of differences will be assumed for the level of p < 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/02/2019
Date of last participant enrolment
Anticipated
Actual
22/04/2019
Date of last data collection
Anticipated
Actual
22/07/2019
Sample size
Target
90
Accrual to date
Final
90
Recruitment outside Australia
Country [1] 23948 0
Poland
State/province [1] 23948 0

Funding & Sponsors
Funding source category [1] 307821 0
University
Name [1] 307821 0
University of Physical Education in Kraków, Poland
Country [1] 307821 0
Poland
Primary sponsor type
Individual
Name
Prof. Agnieszka Suder
Address
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country
Poland
Secondary sponsor category [1] 308529 0
Individual
Name [1] 308529 0
M. Sc. Anna Kabata-Pizuch
Address [1] 308529 0
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country [1] 308529 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307827 0
The Ethical Committee of Regional Medical Chamber in Krakow, Poland
Ethics committee address [1] 307827 0
Ethics committee country [1] 307827 0
Poland
Date submitted for ethics approval [1] 307827 0
10/12/2018
Approval date [1] 307827 0
22/01/2019
Ethics approval number [1] 307827 0
3/KBL/OIL/2019

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

Contacts
Principal investigator
Name 108642 0
Prof Agnieszka Suder
Address 108642 0
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow, Poland
Country 108642 0
Poland
Phone 108642 0
+48126831104
Fax 108642 0
Email 108642 0
[email protected]
Contact person for public queries
Name 108643 0
Anna Kabata-Pizuch
Address 108643 0
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow, Poland
Country 108643 0
Poland
Phone 108643 0
+48126831104
Fax 108643 0
Email 108643 0
[email protected]
Contact person for scientific queries
Name 108644 0
Agnieszka Suder
Address 108644 0
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow, Poland
Country 108644 0
Poland
Phone 108644 0
+48126831104
Fax 108644 0
Email 108644 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
EmbaseAlterations of Body Composition, Blood Morphology and Fibrinogen Concentration after Vibration Therapy in Older Adult Women: A Randomized Controlled Trial.2023https://dx.doi.org/10.3390/jcm12206620
N.B. These documents automatically identified may not have been verified by the study sponsor.