Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000536864
Ethics application status
Approved
Date submitted
19/02/2020
Date registered
6/05/2021
Date last updated
6/05/2021
Date data sharing statement initially provided
6/05/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of sprint training on health outcomes in individuals with obesity
Scientific title
Effect of sprint training on hormone and metabolic responses, oxidative stress, inflammation and bone health in individuals with obesity.
Secondary ID [1] 300602 0
None
Universal Trial Number (UTN)
Trial acronym
STOB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 316355 0
Condition category
Condition code
Metabolic and Endocrine 314614 314614 0 0
Normal metabolism and endocrine development and function
Diet and Nutrition 314615 314615 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exercise testing
The exercise testing was conducted on three different days (D1, D2, and D3) separated by 48h between each testing session. The exercise testing was performed at the beginning of the training program, after 6 weeks and at the end of the 12 weeks.
The maximal incremental exercise test On D1, participants underwent an incremental exercise test to exhaustion on a cycle ergometer (Ergoline, ER900, Germany) to determine Maximal Aerobic Power (MAP) and peak oxygen uptake (VO2peak). During the test, respiratory-gas exchange was measured breath-by-breath using a calibrated portable telemetric system (Cosmed K4b2, Rome, Italy) and data was reported as an average of 30-s intervals. Heart rate (HR) was recorded through an ECG Screening. Participants began cycling at 75W for 4 minutes, and then 2 stages of 6 minutes at 90W and 110W and afterward the power output was progressively increased by 20 W every 2 min until exhaustion. The achievement of VO2peak has been based on at least 3 of the following criteria: a plateau in oxygen consumption despite an increase in exercise intensity, a respiratory exchange ratio greater than 1.1, a maximal heart rate above 90% of the predicted maximal theoretical heart rate (220 – age in years), and the apparent exhaustion of the subject.
Force–velocity test (F/V)
On D2, the F/V test was performed on a cycle ergometer (Monark, Sweden) using a technique adapted from earlier studies. Participants warmed-up for 10 min at 60W. After 5 min of passive recovery, they underwent a succession of supramaximal bouts of approximately 6 s. The braking force administrated at the beginning of the sprint cycling was 2kg and then it was increased by 2 kg after each bout until inability to pursue the test. 5 min of passive recovery was taken after each cycling sprint. Power output was calculated by multiplying the load and speed, and a power curve was then compiled for each bout. The optimal load (Lmax) corresponding to the test was used for the cycling sprint test (CST) on D3 and the maximal power (Ppeak) was used for the training programme.
CST
On D3, participants arrived at the laboratory after a 12-hour fast. They were provided a standardized breakfast (650 Kcal, 55% carbohydrates, 33% lipids, and 12% proteins) before performing the test. They warmed up for 15 min at 60 W and performed the CST test, which consisted of performing 7 repetitions of 6-s "all out" sprints, on cycle ergometer (Monark, Sweden) interspersed with 90 s of passive recovery. They were asked to cycle as fast as possible during the whole test. The velocity was recorded throughout the trials and served to determine the mean power output (Pmean): the mean of repetitions and the maximal power output (Pmax): the best power outputs developed during the CST.
The percent Work decrement (WD%) was calculated according to this formula, since the percentage decrement calculation seems to be the most valid and reliable method of quantifying fatigue :
WD% = 100 - (Total work / ideal work × 100)
The total work was the sum of all sprint bouts work and the ideal work was the work corresponding the highest bouts performance.
Training Program
Participants underwent 12 weeks of training supervised sessions. The program was divided into 2 same parts (2 x 6 weeks) between which, mid-training assessment for Force/Velocity test was performed in order to adjust training load.
The SIT protocol training consisted of 4 sessions per week. Each session began with 10 min warm-up at 60 W and ended with 5 min cool-down for a total session time of ~ 30 min. Exercise session included 3 sets of repeated 3 × 10s of "all out" sprints. Participants were asked to pedal at maximal velocity against a resistance corresponding to 75%-100% Ppeak separated by 90s of passive recovery between cycling bouts and 5 min of passive recovery between each set. Progressive overload was applied by increasing the number of sprint repetitions and/or 5% Ppeak.
The training program was performed in the laboratory and supervised by two sport scientists.
Each training session was delivered two-on-two and the adherence was monitored for each participant.
Intervention code [1] 316911 0
Lifestyle
Comparator / control treatment
A control group (CG) invloved young males with obesity. CG will not trained and but only participate to the testing procedures.
Control group
Active

Outcomes
Primary outcome [1] 322946 0
- Gut hormones (blood analysis): ghrelin, glucagon-like peptide 1, peptide YY, pancreatic
polypeptide, cholecystokinin, and leptin.
Timepoint [1] 322946 0
Baseline, 6 weeks (primary timepoint) and 12 weeks after intervention commencement
Primary outcome [2] 323189 0
-Inflammation (blood analysis): interleukin-1 (IL-1), IL-6 and tumour necrosis factor-alpha (TNF-a), resistin, vaspin, omentin-1, RBP-4, apelin, visfatin and MCP-1
Timepoint [2] 323189 0
Baseline, 6 weeks (primary timepoint) and 12 weeks after intervention commencement
Primary outcome [3] 323190 0
- Oxydative stress (blood analysis): CAT catalase, GPx glutathione peroxidase, GSH glutathione, LPx lipid peroxidation, MDA malondialdehyde, MPO myeloperoxidase, pCarb protein carbonyl, POVPC/PGPC 1-palmitoyl-2-(5-oxovaleroyl)-sn-glycero-3-phosphorylcholine, SOD1/SOD2 superoxide dismutase, TBARS thiobarbituric acid-reactive substances, TEAC trolox equivalentantioxidant capacity,
Timepoint [3] 323190 0
Baseline, 6 weeks (primary timepoint) and 12 weeks after intervention commencement
Secondary outcome [1] 380339 0
Changes in body fat percentage (DEXA)
Timepoint [1] 380339 0
Baseline, 6 weeks and 12 weeks after intervention commencement

Eligibility
Key inclusion criteria
- Sedentary males
- Age between 18 and 40 years old
- Body mass index (BMI) > 30 kg.m-2
- metabolically healthy
Minimum age
18 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Participants were required to be
- sedentary (exercising less than 30 min/week) and nonsmokers
- moderate to no consumption of alcohol and caffeine.
- After a medical screening, none of them had identified cardiomyopathy, endocrine disorders, or orthopedic problems that would limit their participation in the training program.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The person who determined if a subject was eligible for inclusion in the trial was unaware, when this decision was made, to which group the subject would be allocated.
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
A priori power analysis (desired power = 0.80, and alpha error = 0.05) was computed to estimate a statistically significant group by a time-interaction effect based on previous research. The analysis revealed a sample size of n = 10.76 per group. To account for potential dropouts, 17 participants were included in each of the two study groups.
Data are presented as means ± standard deviations (M±SD). After normality of data distribution was confirmed using the Shapiro-Wilk test, differences within and between groups were calculated using a two-way analysis of variance (ANOVA) for repeated measures. If the group x time interactions were significant, a Newman-Keul’s post hoc test was calculated. Relationships between parameters were assessed using Pearson’s product-moment correlation coefficient (r). Additionally, effect sizes (ES) were determined from ANOVA output by converting partial eta-squared to Cohen’s d. Moreover, within-group ES were computed using the following equation: ES = (mean post – mean pre)/SD (Cohen, 1988). In accordance with Hopkins et al., ES were considered trivial (< 0.2), small (0.2-0.6), moderate (0.6-1.2), large (1.2-2.0) and very large (2.0-4.0) (Hopkins et al. 2009). The level of significance was set at p<0.05. All statistical analyses were computed using SPSS for Windows, version 16.0 (SPSS Inc, USA).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
10/03/2021
Date of last participant enrolment
Anticipated
29/05/2021
Actual
Date of last data collection
Anticipated
15/11/2021
Actual
Sample size
Target
40
Accrual to date
33
Final
Recruitment outside Australia
Country [1] 22366 0
Tunisia
State/province [1] 22366 0
Tunis

Funding & Sponsors
Funding source category [1] 305024 0
Self funded/Unfunded
Name [1] 305024 0
Prof. H. ZOUHAL
Country [1] 305024 0
France
Funding source category [2] 305220 0
Self funded/Unfunded
Name [2] 305220 0
Dr. Ben Abderrahman Abderraouf
Country [2] 305220 0
Tunisia
Primary sponsor type
Individual
Name
Prof. H. ZOUHAL
Address
University of Rennes 2
Av Henri Le Moal
35044 Rennes-Cedex
France
Country
France
Secondary sponsor category [1] 305384 0
Individual
Name [1] 305384 0
Dr. A. Ben Abderrahman
Address [1] 305384 0
ISSEP Ksar Essaid, University of La Manouba,
1000, Tunis
Tunisia
Country [1] 305384 0
Tunisia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305419 0
Ethics Committee of the Medical Sport Center and Sport Sciences (Tunis, Tunisia) and the University of Sciences El Manar (Tunis, Tunisia)
Ethics committee address [1] 305419 0
Ethics committee country [1] 305419 0
Tunisia
Date submitted for ethics approval [1] 305419 0
10/12/2019
Approval date [1] 305419 0
30/01/2020
Ethics approval number [1] 305419 0

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

Contacts
Principal investigator
Name 100318 0
Prof Hassane ZOUHAL
Address 100318 0
University of Rennes 2,
Place Henri le Moal
35044 Rennes-Cedex
France
Country 100318 0
France
Phone 100318 0
+33 6 74 60 54 19
Fax 100318 0
Email 100318 0
[email protected]
Contact person for public queries
Name 100319 0
Hassane ZOUHAL
Address 100319 0
University of Rennes 2,
Place Henri le Moal
35044 Rennes-Cedex
France
Country 100319 0
France
Phone 100319 0
+33 6 74 60 54 19
Fax 100319 0
Email 100319 0
[email protected]
Contact person for scientific queries
Name 100320 0
Hassane ZOUHAL
Address 100320 0
University of Rennes 2,
Place Henri le Moal
35044 Rennes-Cedex
France
Country 100320 0
France
Phone 100320 0
+33 6 74 60 54 19
Fax 100320 0
Email 100320 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Age - Anthropometric measurements - Physical performances - Blood data analysis
When will data be available (start and end dates)?
Start : March, 30th 2020
End : June, 30th 2020
Available to whom?
For scientific researchers who request data
Available for what types of analyses?
Meta-analysis
How or where can data be obtained?
By request to :
[email protected]


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
No additional documents have been identified.