Trial Outcomes & Findings for Whole-body Vibration With or Without Localized Radiofrequency and Body Composition in Obese Female (NCT NCT01329328)
NCT ID: NCT01329328
Last Updated: 2020-09-24
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
2 months
Results posted on
2020-09-24
Participant Flow
Participant milestones
| Measure |
CONTROL
CONTROL GROUP NO INTERVENTION
|
WHOLE-BODY VIBRATION
EXERCISE ON A VIBRATION DEVICE (BIOPLATE RF, BIOS, MILAN, ITALY
|
WHOLE-BODY VIBRATION PLUS RADIOFREQUENCY
EXERCISE ON A VIBRATION DEVICE (BIOPLATE RF,BIOS, MILAN, ITALY) PLUS LOCAL ADMINISTRATION OF RADIOFREQUENCY
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
17
|
18
|
|
Overall Study
COMPLETED
|
13
|
13
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
3
|
Reasons for withdrawal
| Measure |
CONTROL
CONTROL GROUP NO INTERVENTION
|
WHOLE-BODY VIBRATION
EXERCISE ON A VIBRATION DEVICE (BIOPLATE RF, BIOS, MILAN, ITALY
|
WHOLE-BODY VIBRATION PLUS RADIOFREQUENCY
EXERCISE ON A VIBRATION DEVICE (BIOPLATE RF,BIOS, MILAN, ITALY) PLUS LOCAL ADMINISTRATION OF RADIOFREQUENCY
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
3
|
Baseline Characteristics
Whole-body Vibration With or Without Localized Radiofrequency and Body Composition in Obese Female
Baseline characteristics by cohort
| Measure |
CONTROL
n=15 Participants
NO VIBRATION EXERCISE
|
VIBRATION EXERCISE
n=17 Participants
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
|
VIBRATION EXERCISE PLUS RADIOFREQUENCY ADMINISTRATION
n=18 Participants
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
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46.3 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
49.0 years
STANDARD_DEVIATION 5.6 • n=7 Participants
|
45.4 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
46.8 years
STANDARD_DEVIATION 7.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2 monthsEvidence 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
Outcome measures
| Measure |
CONTROL
n=13 Participants
NO VIBRATION EXERCISE
|
VIBRATION EXERCISE
n=13 Participants
WHOLE-BODY VIBRATION EXERCISE ON A VIBRATION DEVICE (BIOPLATE RF, BIOS, MILAN, ITALY
vibrating platform (Bioplate RF): whole body vibration exercise with multiple positions, with or without localized delivery of heating radiofrequency
|
VIBRATION EXERCISE PLUS RADIOFREQUENCY ADMINISTRATION
n=15 Participants
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 or without localized delivery of heating radiofrequency
|
|---|---|---|---|
|
Body Composition
|
44.8 PECENTAGE OF WHOLE-BODY FAT
Standard Deviation 3.9
|
43.4 PECENTAGE OF WHOLE-BODY FAT
Standard Deviation 4.1
|
44.0 PECENTAGE OF WHOLE-BODY FAT
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: 2 monthsevidence of changes in lower limbs muscular strength following 2 months of whole-body vibration
Outcome measures
| Measure |
CONTROL
n=13 Participants
NO VIBRATION EXERCISE
|
VIBRATION EXERCISE
n=13 Participants
WHOLE-BODY VIBRATION EXERCISE ON A VIBRATION DEVICE (BIOPLATE RF, BIOS, MILAN, ITALY
vibrating platform (Bioplate RF): whole body vibration exercise with multiple positions, with or without localized delivery of heating radiofrequency
|
VIBRATION EXERCISE PLUS RADIOFREQUENCY ADMINISTRATION
n=15 Participants
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 or without localized delivery of heating radiofrequency
|
|---|---|---|---|
|
Muscular Strength
|
212.0 KILOGRAMS
Standard Deviation 43.10
|
217.3 KILOGRAMS
Standard Deviation 49.9
|
213.8 KILOGRAMS
Standard Deviation 56.5
|
Adverse Events
CONTROL
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
VIBRATION EXERCISE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
VIBRATION EXERCISE PLUS RADIOFREQUENCY ADMINISTRATION
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place