Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001352594
Ethics application status
Approved
Date submitted
24/09/2024
Date registered
8/11/2024
Date last updated
8/11/2024
Date data sharing statement initially provided
8/11/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Long-term adaptations of high-intensity interval training
Scientific title
Long-Term Physiological Adaptations Induced by Short-Interval High-Intensity Exercises: an RCT comparing active and passive recovery in trained young adults
Secondary ID [1] 313035 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiorespiratory Fitness 335440 0
Body Power 335442 0
Body Composition 335254 0
Body Strength 335441 0
Agility 335599 0
Condition category
Condition code
Musculoskeletal 332002 332002 0 0
Normal musculoskeletal and cartilage development and function
Public Health 331827 331827 0 0
Health promotion/education
Cardiovascular 332001 332001 0 0
Normal development and function of the cardiovascular system
Physical Medicine / Rehabilitation 332000 332000 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
High-intensity interval training combining running and free-body exercises.
The intervention includes an active recovery of nearly 60% of the participant's maximal heart rate, while passive recovery does not include exercise during rest time. The active recovery includes walking (or running) at a speed related to 60% HRmax, within an apposite gym space. The space dimension is adapted allowing participants to run at the prescribed speed (number of laps in the rest time).
A trained kinesiologist supervises exercise.
A group-based training of four participants is administered.
Each session lasts about 50 minutes and the protocol includes two weekly sessions.
The intervention lasts 8 weeks.
Participants fill out an exercise diary during each session, in which the number of repetitions and the external load are reported. In addition, the heart rate is monitored by a Bluetooth device and the average and peak levels are reported. Finally, after 30 minutes at the end of each session, participants are instructed to report the perceived effort through a validated scale.
Training exercises follow:
session 1) shuttle run (4 meters), squat to press, mountain climber, renegade row, jumping split lunges, 8 sip low skips, push-up;
session 2) dumbell woodchopper, high knees skips, kettlebell swing, agility drills, side shuttle (3 meters), squat jump, plank leg raises, burpees.
Intervention code [1] 329584 0
Behaviour
Intervention code [2] 329585 0
Treatment: Other
Intervention code [3] 329734 0
Lifestyle
Comparator / control treatment
Control treatment performs a passive recovery, with no physical effort during the recovery between each series and exercise. Other treatment conditions do not vary between intervention and control during the protocol.
Control group
Active

Outcomes
Primary outcome [1] 339602 0
Limb muscle and fat areas are assessed together as a composite primary outcome.
Timepoint [1] 339602 0
Baseline and three days post-intervention completion
Primary outcome [2] 339601 0
Intra and extracellular water, are assessed together as a composite primary outcome.
Timepoint [2] 339601 0
Baseline and three days post-intervention completion
Primary outcome [3] 339448 0
Body fat and fat-free mass, are assessed together as a composite primary outcome.
Timepoint [3] 339448 0
Baseline and three days post-intervention completion
Secondary outcome [1] 440560 0
Physical performance: Handgrip strength
Timepoint [1] 440560 0
Baseline and four days post-intervention completion
Secondary outcome [2] 440561 0
Physical performance: Power
Timepoint [2] 440561 0
Baseline and four days post-intervention completion
Secondary outcome [3] 440562 0
Physical performance: Agility
Timepoint [3] 440562 0
Baseline and four days post-intervention completion
Secondary outcome [4] 440031 0
Physical performance: maximal oxygen consumption (VO2 peak)
Timepoint [4] 440031 0
Baseline and five days post-intervention completion

Eligibility
Key inclusion criteria
Healthy people with no diseases that could affect physical performance; at least five years of sports experience; Medical certification for participation in high-intensity exercise; 7 days of was-out before the first evaluation
Minimum age
18 Years
Maximum age
32 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participation in other exercises or sports; lacks more than one protocol training; onset of any injection or condition that could affect physical performance

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)
Allocation by software
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A priori sample size was computed with the following parameters:
alpha=0.05, 1-beta= 0.8, delta=0.707, correlation among measures = 0.7.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/09/2023
Date of last participant enrolment
Anticipated
Actual
10/10/2023
Date of last data collection
Anticipated
Actual
29/12/2023
Sample size
Target
20
Accrual to date
Final
18
Recruitment outside Australia
Country [1] 26572 0
Italy
State/province [1] 26572 0
Bologna

Funding & Sponsors
Funding source category [1] 317477 0
University
Name [1] 317477 0
University of Bologna
Country [1] 317477 0
Italy
Primary sponsor type
University
Name
University of Bologna
Address
Country
Italy
Secondary sponsor category [1] 319769 0
None
Name [1] 319769 0
Address [1] 319769 0
Country [1] 319769 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316191 0
University of Bologna ethics committee
Ethics committee address [1] 316191 0
Ethics committee country [1] 316191 0
Italy
Date submitted for ethics approval [1] 316191 0
24/02/2023
Approval date [1] 316191 0
03/03/2023
Ethics approval number [1] 316191 0
0058589

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

Contacts
Principal investigator
Name 137082 0
Mr Mario Mauro
Address 137082 0
Alma Mater Studiorum - University of Bologna, Department of Life Quality Sciences, Corso d'Augusto, 237, 47921 Rimini RN
Country 137082 0
Italy
Phone 137082 0
+393388259249
Fax 137082 0
Email 137082 0
[email protected]
Contact person for public queries
Name 137083 0
Stefania Toselli
Address 137083 0
Alma Mater Studiorum - University of Bologna, Department of Life Quality Sciences, Corso d'Augusto, 237, 47921 Rimini RN
Country 137083 0
Italy
Phone 137083 0
+393397450159
Fax 137083 0
Email 137083 0
[email protected]
Contact person for scientific queries
Name 137084 0
Mario Mauro
Address 137084 0
Alma Mater Studiorum - University of Bologna, Department of Life Quality Sciences, Corso d'Augusto, 237, 47921 Rimini RN
Country 137084 0
Italy
Phone 137084 0
+393388259249
Fax 137084 0
Email 137084 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Sharing with other researchers for IPD meta-analysis or any research purpose.

Conditions for requesting access:
• -

What individual participant data might be shared?
• Individual participant data of published results only, in an anonymous format.

What types of analyses could be done with individual participant data?
• any purpose

When can requests for individual participant data be made (start and end dates)?
From:
From 2nd September 2024. Data will be available indefinitely (no end date).

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Data is available via the website at the following DOI:
10.5281/zenodo.13627555

Are there extra considerations when requesting access to individual participant data?
No


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.