ANZCTR - Registration

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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]

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

Condition category

Condition code

Metabolic and Endocrine

Metabolic disorders

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Diet and Nutrition

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]

Rehabilitation

Intervention code [2]

Lifestyle

Intervention code [3]

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]

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]

Baseline and after 8-week intervention

Primary outcome [2]

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]

Baseline and after the 8-week intervention

Secondary outcome [1]

waist circumference

Timepoint [1]

at baseline and end-of-study (at 8 weeks).

Secondary outcome [2]

body mass index (BMI)

Timepoint [2]

at baseline and end-of-study (at 8 weeks).

Secondary outcome [3]

resting blood pressure assessed using automatic sphygmomanometer

Timepoint [3]

baseline and end-of-study (at 8 weeks).

Secondary outcome [4]

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]

baseline and end-of-study (at 8 weeks).

Secondary outcome [5]

High sensitivity-C-reactive protein. Serum assay using Reflotron plus (Reflotron Registered Trademark plus, Bio-Stat Diagnostic Systems, USA).

Timepoint [5]

baseline and end-of-study (at 8 weeks).

Secondary outcome [6]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/02/2013

Actual

1/02/2013

Date of last participant enrolment

Anticipated

31/03/2013

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Spain

State/province [1]

Seville

Funding & Sponsors

Funding source category [1]

University

Name [1]

Department of Physical Education and Sport. University of Seville

Address [1]

Facultad Ciencias de la Educacion. c/ Pirotecnia s/n. E-41013. Seville (Spain)

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Seville

Ethics committee address [1]

Vicerrectorado de Investigacion. Universidad de Sevilla. Pabellon de Brasil. Paseo de las Delicias s/n. Sevilla

Ethics committee country [1]

Spain

Date submitted for ethics approval [1]

25/01/2013

Approval date [1]

01/03/2013

Ethics approval number [1]

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

Dr Borja Sanudo

Address

Department of Physical Education and Sport. University of Seville. C/ Pirotecnia s/n. E-41013. Seville

Country

Spain

Phone

+34652387090

Fax

bsancor@us.es

Contact person for public queries

Name

Borja Sanudo

Address

Department of Physical Education and Sport. University of Seville. C/ Pirotecnia s/n. E-41013. Seville

Country

Spain

Phone

+34652387090

Fax

bsancor@us.es

Contact person for scientific queries

Name

Borja Sanudo

Address

Department of Physical Education and Sport. University of Seville. C/ Pirotecnia s/n. E-41013. Seville

Country

Spain

Phone

+34652387090

Fax

bsancor@us.es

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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