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Trial registered on ANZCTR


Registration number
ACTRN12613000287730
Ethics application status
Approved
Date submitted
5/03/2013
Date registered
12/03/2013
Date last updated
12/03/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of high intensity exercise training and vibration recovery on key health outcomes and weight control in overweight/obese people
Scientific title
Effectiveness of high intensity exercise training and vibration recovery on key health outcomes and weight control in overweight/obese people
Secondary ID [1] 282067 0
None
Universal Trial Number (UTN)
U1111-1140-1566
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
overweight/obese people 288554 0
Condition category
Condition code
Metabolic and Endocrine 288883 288883 0 0
Metabolic disorders
Physical Medicine / Rehabilitation 288884 288884 0 0
Other physical medicine / rehabilitation
Diet and Nutrition 288904 288904 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: High Intensity Interval Training (HIIT; 6 sets and then progressively increased to 10 sets over time x 1 min of high intensity aerobic training cycling on a stationary ergometer at 90%Heart rate Max) followed by 4 min of pasive recovery after each of the 1 min sets.
Arm 2: the same HIIT followed by vibration recovery (1 min of inter-set recovery at a frequency of 25 Hz and a peak to peak displacement of 4 mm).
In both groups caloric intake (55% complex carbohydrates, 30% fat, and 15% protein) will be reduced to obtain a negative balance of 500 kcal/day. The training sessions will be performed three times a week for 8 weeks and in all cases one-on-one supervised by an exercise physiologist
Intervention code [1] 286666 0
Rehabilitation
Intervention code [2] 286676 0
Lifestyle
Intervention code [3] 286677 0
Treatment: Other
Comparator / control treatment
Arm 3:Usual-care control group that will continue with their daily activities (without structured exercise) and with a negative balance of 500 kcal/day.
Control group
Active

Outcomes
Primary outcome [1] 289015 0
Insulinemia and HOMA index calculated as fasting serum insulin level (Milliunits per Liter) multiplied by fasting plasma glucose level (mmol/l)/22.5.
Biochemical determinations will be always carried out in
blood drawn in the morning after an overnight fast of 12 h.
Blood samples were cooled in ice water and immediately
centrifuged at 1000g for 45 min at 48C.
Timepoint [1] 289015 0
Baseline and after 8-week intervention
Primary outcome [2] 289016 0
Body composition (percentage of body fat and fat-free mass) assessed by means of Bio-electrical impedance using Bodystat Copyright 1500 analyzer (Bodystat Ltd, Douglas, Isle of Man, UK).
Timepoint [2] 289016 0
Baseline and after the 8-week intervention
Secondary outcome [1] 301566 0
waist circumference
Timepoint [1] 301566 0
at baseline and end-of-study (at 8 weeks).
Secondary outcome [2] 301567 0
body mass index (BMI)
Timepoint [2] 301567 0
at baseline and end-of-study (at 8 weeks).
Secondary outcome [3] 301568 0
resting blood pressure assessed using automatic sphygmomanometer
Timepoint [3] 301568 0
baseline and end-of-study (at 8 weeks).
Secondary outcome [4] 301569 0
Triglycerides, total, HDL and LDL cholesterol. Serum assay using Reflotron plus (Reflotron Registered Trademark plus, Bio-Stat Diagnostic Systems, Pepper Road, Hazel Grove, Strockport, Cheshire SK7 5BW (USA).
Timepoint [4] 301569 0
baseline and end-of-study (at 8 weeks).
Secondary outcome [5] 301570 0
High sensitivity-C-reactive protein. Serum assay using Reflotron plus (Reflotron Registered Trademark plus, Bio-Stat Diagnostic Systems, USA).
Timepoint [5] 301570 0
baseline and end-of-study (at 8 weeks).
Secondary outcome [6] 301572 0
Fitness (6-min walk test, hand-grip strength -using a Takei dynamometer- and lower-limb strength -measured by a load cell (Model 333A) connected to an A/D converting system (MuscleLab Registered Trademark, Ergotest AS, Langesund, Norway-)
Timepoint [6] 301572 0
Baseline and after 8 week intervention

Eligibility
Key inclusion criteria
a) BMI greater than or equal to 25 kg/m2
b) Sedentary participants (determined by means of the International Questionnaire of Physical Activity)
Minimum age
20 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include history or evidence of advanced cardiovascular (including SBP > 160 mmHG and DBP > 100 mmHG), renal or hepatic diseases, retinopathy, nephropathy, or neuropathy, orthopedic or other limitations that may interfere with their ability to exercise safely. Participants with Type I or II diabetes also will be excluded. Moreover, participants receiving physical therapy were excluded to avoid possible interactions with the present intervention.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4897 0
Spain
State/province [1] 4897 0
Seville

Funding & Sponsors
Funding source category [1] 286842 0
University
Name [1] 286842 0
Department of Physical Education and Sport. University of Seville
Address [1] 286842 0
Facultad Ciencias de la Educacion. c/ Pirotecnia s/n. E-41013. Seville (Spain)
Country [1] 286842 0
Spain
Primary sponsor type
University
Name
University of Seville
Address
Facultad de Ciencias de la Educacion. C/ Pirotecnia s/n. E- 41013. Seville
Country
Spain
Secondary sponsor category [1] 285631 0
None
Name [1] 285631 0
Address [1] 285631 0
Country [1] 285631 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288907 0
University of Seville
Ethics committee address [1] 288907 0
Vicerrectorado de Investigacion. Universidad de Sevilla. Pabellon de Brasil. Paseo de las Delicias s/n. Sevilla
Ethics committee country [1] 288907 0
Spain
Date submitted for ethics approval [1] 288907 0
25/01/2013
Approval date [1] 288907 0
01/03/2013
Ethics approval number [1] 288907 0

Summary
Brief summary
Exercise plays a key role in the prevention and treatment of overweight and reduction of body weight by lifestyle intervention is often modest. High intensity interval training (HIIT) characterized by repeated efforts at near-maximal to supramaximal work rates, interspersed with periods of recovery, has recently been used as an alternative to traditional endurance training to alter cardiorespiratory fitness and muscle metabolism. However, the optimal prescription with regards to intensity, work and rest duration, and number of intervals have yet to be elucidated. Alternatively, whole body vibration (WBV), which is a novel training intervention, has been proven to be a safe and effective exercise modality for improving body composition and muscle strength in deconditioned individuals. Numerous studies have indicated that WBV can decrease fat mass and increase muscle mass but also upregulate the nitric oxide dilator system and improve endothelial function which may indicate that WBV may be an effective intervention for improving health-related outcomes. To our knowledge this is the first study designed to combine both therapies; consequently, the aim of this study was to extend the previous findings examining the effects of short-term HIIT on overweight/obese people. Secondly, to determine whether vibration recovery lead to additional benefits in this population group. Methods: Fifty participants will be randomly assigned to either a HIIT training group with vibration recovery (WBVT), HIIT training group with passive recovery (HIIT) or usual-care control group (CON). Body composition (waist circumference, waist to hip ratio –WHR-, weight, height, percentage of body fat and fat-free mass), heart rate (HR), lipid-related cardiovascular risk factors (i.e. cholesterol, triglycerides, HDL, LDL, LDL/HDL and atherogenic index), Insulinemia and HOMA-index, high sensitivity-C-reactive protein and functional capacity as measured by time 6-minute walking test, hand-grip strength and lower-limb maximal strength will be assessed at baseline and after 8-weeks. Since all patients were overweight or obese, caloric intake (55% complex carbohydrates, 30% fat, and 15% protein) will be reduced to obtain a negative balance of 500 kcal/day. Requirements will be calculated by adding the estimated energy expenditure from PA to basal metabolism. WBVT participants will perform 6-10 sets x 1 min of HIIT at 90% heart rate max) followed by 6-10 x 1 min of inter-set vibration recovery at a frequency of 25 Hz and a peak to peak displacement of 4 mm. HIIT groups will perform the same HIIT followed by 4 min of passive recovery while the control group will continue their daily activities with the nutritional advice. As WBV increases leg blood flow and reduces fat mass, we hypothesize that it would provide additional therapeutic benefits to people with overweight characterized by impeded leg blood flow and abdominal obesity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38290 0
Dr Borja Sanudo
Address 38290 0
Department of Physical Education and Sport. University of Seville. C/ Pirotecnia s/n. E-41013. Seville
Country 38290 0
Spain
Phone 38290 0
+34652387090
Fax 38290 0
Email 38290 0
bsancor@us.es
Contact person for public queries
Name 38291 0
Dr Borja Sanudo
Address 38291 0
Department of Physical Education and Sport. University of Seville. C/ Pirotecnia s/n. E-41013. Seville
Country 38291 0
Spain
Phone 38291 0
+34652387090
Fax 38291 0
Email 38291 0
bsancor@us.es
Contact person for scientific queries
Name 38292 0
Dr Borja Sanudo
Address 38292 0
Department of Physical Education and Sport. University of Seville. C/ Pirotecnia s/n. E-41013. Seville
Country 38292 0
Spain
Phone 38292 0
+34652387090
Fax 38292 0
Email 38292 0
bsancor@us.es

No information has been provided regarding IPD availability
Summary results
No Results