Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000229673
Ethics application status
Approved
Date submitted
18/10/2022
Date registered
3/03/2023
Date last updated
3/03/2023
Date data sharing statement initially provided
3/03/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Low intensity training with flow restriction vs. eccentric exercises on the gastrocnemius musculature to increase jumping in amateur basketball players. A randomized clinical trial
Scientific title
Low intensity training with flow restriction vs. eccentric exercises on the gastrocnemius musculature to increase jumping in amateur basketball players. A randomized clinical trial
Secondary ID [1] 308213 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
exercise 327962 0
Condition category
Condition code
Musculoskeletal 325027 325027 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomized controlled trial design was used in 18 amateur basketball players (18-45 years old) of the Molina Basketball Club, who were divided into two groups :
The intervention group (A) followed the low intensity training with flow restriction (40% intensity) with 200 mmhg occlusion applying flow restriction bands in the popliteal area.
For the distribution of groups, the division was carried out in a balanced random manner in two equal samples in 1:1 frequency. The individuals had to select an envelope without knowing the content, among which was the group.
They underwent the exercise protocols without being aware of the types of exercises they were assigned to.
The randomization process will be performed by the coaches who did not participate in this study.
This clinical trial is double-blind. Specifically, the participants are unaware of the participation group assignment and the outcome assessor is unaware of the intervention of each group.
The participants who met the inclusion criteria were 22 amateur basketball players f who signed the informed consent at the beginning of the study and divided into 2 groups: (A) Low intensity training (40% of 1RM) with flow restriction with n= 9 and (B) Eccentric exercise protocol with n= 9.
The players will be evaluated at the beginning of the first training session of week 1 and at the end of week 4 on the last day of training.
The training is planned as follows:
Warm-up: Between (10 – 15 minutes) consisting of jogging at a medium intensity for 6 minutes and exercises with the ball (tackling, throwing, etc.) for 9 minutes. At the end of the warm-up, the players go to carry out the exercises planned for each study group.
Trial intervention: group (A) low intensity training with flow restriction over the gastrocnemius muscles. Location of the band: two fingers below the apex of the patella, with 200mmHg occlusion, 40% intensity of 1 RM and intervention time of 5 minutes.
series :3
Reps:15
Rest: 30 seconds between each series
Exercises: 3
- Lunge position of the athlete.
- Push with unipodal support.
- Plantiflexion with an elastic band of 3-10 kg.
Group (B) protocol of eccentric exercises.
Series: 4
Reps: 15
Rest: 30 seconds between each series.
Exercises:3
- Alfredson exercises.
- Alfredson exercises.
- Exercises with elastic band 3 – 10kg.
the frequency/duration of the training sessions is planed in 1 x 1 hour consultation per week for 4 weeks.
-The mode of administration is planed for groups of 9 participants with one trainer.
-A member of the study team will supervising the trainer.
- No session attendance strategies are planed.


Intervention code [1] 324672 0
Rehabilitation
Comparator / control treatment
The comparator group (B) followed eccentric exercise protocol on the gastrocnemius (5 exercises each of 3 sets of 15 repetitions). An initial evaluation was applied that consists of: Perception of effort, ROM, muscle strength and the jump power.
Concretely the Group (B) protocol of eccentric exercises consists:
Series: 4
Reps: 15
Rest: 30 seconds between each series.
Exercises:3
- Alfredson exercises.
- Alfredson exercises.
- Exercises with elastic band 3 – 10kg.
Control group
Active

Outcomes
Primary outcome [1] 332846 0
Range of motion measured with the athlete position in the prone position with 90° knee flexion to take plantarflexion and dorsiflexion.
Timepoint [1] 332846 0
Baseline and four weeks post- commencement of exercise protocols.
Primary outcome [2] 332847 0
A jump platform of the DMJUMP 2.5 brand will be used through a mobile application (DMLAB) that takes the data of the jump power of the athletes. The athlete stands on the platform in a standing position; The evaluator teaches how to execute the jump, which is: arms on the hip, knee flexion and jump with both feet at the same time; the participant must make three jumps to choose the one with the best score
Timepoint [2] 332847 0
Baseline and four weeks post- commencement of exercise protocols.
Secondary outcome [1] 414864 0
Gastrocnemius perimeter measured with a meter tape with the athlete's in seated position, The measurement will be taken in the most prominent part of the muscle and the perimeter of both legs will be assessed.
Timepoint [1] 414864 0
Baseline and four weeks post- commencement of exercise protocols.

Eligibility
Key inclusion criteria
- Minimum three days of training per week
- Comply with weekly training hours (four and a half hours)
- No presence of injuries at calf level
Minimum age
16 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Professional league basketball players
- Basketball players who have had a previous injury up to 15 days old
- Presence of frequent pain at the level of the Achilles tendon
- Regular gym training (more than 3 times a week).

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
1/02/2023
Date of last participant enrolment
Anticipated
Actual
1/02/2023
Date of last data collection
Anticipated
4/03/2023
Actual
Sample size
Target
22
Accrual to date
Final
18
Recruitment outside Australia
Country [1] 25067 0
Spain
State/province [1] 25067 0

Funding & Sponsors
Funding source category [1] 312469 0
University
Name [1] 312469 0
Universidad Católica San Antonio de Murcia
Country [1] 312469 0
Spain
Primary sponsor type
University
Name
Universidad Católica San Antonio de Murcia
Address
Universidad Católica San Antonio de Murcia
Campus de los Jerónimos, Guadalupe 30107
(Murcia) - España
Country
Spain
Secondary sponsor category [1] 314052 0
None
Name [1] 314052 0
None
Address [1] 314052 0
None
Country [1] 314052 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311814 0
Universidad Católica San Antonio de Murcia
Ethics committee address [1] 311814 0
Ethics committee country [1] 311814 0
Spain
Date submitted for ethics approval [1] 311814 0
Approval date [1] 311814 0
27/01/2021
Ethics approval number [1] 311814 0

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

Contacts
Principal investigator
Name 122458 0
Prof Jasemin Todri
Address 122458 0
Universidad Católica San Antonio de Murcia
Campus de los Jerónimos, Guadalupe 30107
(Murcia) - España
Country 122458 0
Spain
Phone 122458 0
+34 968 27 88 00
Fax 122458 0
Email 122458 0
[email protected]
Contact person for public queries
Name 122459 0
Jasemin Todri
Address 122459 0
Universidad Católica San Antonio de Murcia
Campus de los Jerónimos, Guadalupe 30107
(Murcia) - España
Country 122459 0
Spain
Phone 122459 0
+34 968 27 88 00
Fax 122459 0
Email 122459 0
[email protected]
Contact person for scientific queries
Name 122460 0
Jasemin Todri
Address 122460 0
Universidad Católica San Antonio de Murcia
Campus de los Jerónimos, Guadalupe 30107
(Murcia) - España
Country 122460 0
Spain
Phone 122460 0
+34 968 27 88 00
Fax 122460 0
Email 122460 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.