Obesity
Conditions
Keywords
whole-body vibration, radiofrequency, muscular strength, exercise, body composition
Brief summary
The aim of this study is to evaluate the effect of whole-body vibration in the presence or absence of localized radiofrequency on body composition in obese female subjects. Moreover, strength tests will be performed. The study hypothesis is that whole-body vibration induces positive changes in body composition i.e., reduction of fat mass and increase of lean mass with associated increase in performance. The possible additive role of radiofrequency will also be assessed.
Detailed description
* recruitment of female obese subjects * baseline assessment (body composition with dual energy x-ray absorptiometry (DXA) and strength tests) * 2-mo whole body vibration training (2 sessions a week, 30 min per session) with or without local delivery of radiofrequency (two randomly selected groups) * final assessment (body composition with DXA and strength tests) * data collation and analysis
Interventions
DEVICEvibrating platform (Bioplate RF)
whole body vibration exercise with multiple positions, with or without localized delivery of heating radiofrequency
Sponsors
Bios S.r.l.
Universita di Verona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI: \>25 * normal locomotion * informed consent form signed
Exclusion criteria
* acute illness * endocrine pathologies or diabetes mellitus * vascular pathology * pacemaker * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Composition | 2 months | Evidence of changes in body composition (three-compartment model as assessed by dual-energy X-ray absorptiometry) after two months of whole-body vibration with or without application of localized radiofrequency |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscular Strength | 2 months | evidence of changes in lower limbs muscular strength following 2 months of whole-body vibration |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CONTROL NO VIBRATION EXERCISE | 15 |
| VIBRATION EXERCISE WHOLE-BODY VIBRATION EXERCISE ON A VIBRATION DEVICE (BIOPLATE RF, BIOS, MILAN, ITALY
vibrating platform (Bioplate RF): whole body vibration exercise with multiple positions, without localized delivery of heating radiofrequency | 17 |
| VIBRATION EXERCISE PLUS RADIOFREQUENCY ADMINISTRATION WHOLE-BODY VIBRATION EXERCISE ON A VIBRATION DEVICE (BIOPLATE RF, BIO, MILAN, ITALY PLUS LOCAL ADMINISTRATION OF RADIOFREQUENCY
vibrating platform (Bioplate RF): whole body vibration exercise with multiple positions, with localized delivery of heating radiofrequency | 18 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 4 | 3 |
Baseline characteristics
| Characteristic | CONTROL | VIBRATION EXERCISE | VIBRATION EXERCISE PLUS RADIOFREQUENCY ADMINISTRATION | Total |
|---|---|---|---|---|
| Age, Continuous | 46.3 years STANDARD_DEVIATION 5.6 | 49.0 years STANDARD_DEVIATION 5.6 | 45.4 years STANDARD_DEVIATION 10.4 | 46.8 years STANDARD_DEVIATION 7.8 |
| Sex: Female, Male Female | 15 Participants | 17 Participants | 18 Participants | 50 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 17 | 0 / 18 |
| serious Total, serious adverse events | 0 / 15 | 0 / 17 | 0 / 18 |
Outcome results
Primary
Body Composition
Evidence of changes in body composition (three-compartment model as assessed by dual-energy X-ray absorptiometry) after two months of whole-body vibration with or without application of localized radiofrequency
Time frame: 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CONTROL | Body Composition | 44.8 PECENTAGE OF WHOLE-BODY FAT | Standard Deviation 3.9 |
| VIBRATION EXERCISE | Body Composition | 43.4 PECENTAGE OF WHOLE-BODY FAT | Standard Deviation 4.1 |
| VIBRATION EXERCISE PLUS RADIOFREQUENCY ADMINISTRATION | Body Composition | 44.0 PECENTAGE OF WHOLE-BODY FAT | Standard Deviation 3.7 |
Secondary
Muscular Strength
evidence of changes in lower limbs muscular strength following 2 months of whole-body vibration
Time frame: 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CONTROL | Muscular Strength | 212.0 KILOGRAMS | Standard Deviation 43.1 |
| VIBRATION EXERCISE | Muscular Strength | 217.3 KILOGRAMS | Standard Deviation 49.9 |
| VIBRATION EXERCISE PLUS RADIOFREQUENCY ADMINISTRATION | Muscular Strength | 213.8 KILOGRAMS | Standard Deviation 56.5 |