Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000751279p
Ethics application status
Not yet submitted
Date submitted
29/04/2018
Date registered
4/05/2018
Date last updated
4/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise program of the gluteal muscles and its effect on the vertical jump.
Scientific title
Effectiveness of gluteal exercise programs and the effects on vertical jump in amateur sport players: a simple blind randomized controlled trial.
Secondary ID [1] 294741 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gluteal muscle development in amateur atheletes 307625 0
Condition category
Condition code
Musculoskeletal 306693 306693 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two groups will be randomize in control group and the exercise
- Group control: The first measurement will be made at the beginning of the study using “my jump 2” App and while the participants are doing the Squat jump test (SJ).
The Second measurement will be done 8 weeks later while the participants will carry on their usual training routine without performing any type of gluteal exercises.
Finally another measurement will be done 4 weeks after the last one in the same


-Exercise group: The first measurement will be made at the beginning of the study using “my jump 2” App and while the participants are doing the Squat jump test (SJ).
The Second measurement will be done 8 weeks later while the participants perform a program of specific gluteal muscle exercises four times a week.
Finally another measurement will be done 4 weeks after the last one, while the participants continue with their normal routine and stop doing the specific gluteal muscle exercises.


Squat jump test: Requires the athlete to ‘pause’ in a flexed semi-squat position for several seconds before initiating the upward/concentric phase and jump. Both hands will be place on the hips during all the jump process. Then, the athlete will jump as much as he/she can.

Description of the gluteal muscle exercises:
1. Unilateral supine bridge
2. Side plank with added hip abduction
3. Quadruped bent knee hip extension
4. Split Squat
5. Side lying hip abduction

All those exercises have been select based in different studies proving their efficacy on gluteus medius activation.
- Frequency/ duration of the intervention: 5 exercises in total, 3x10 (series x repetitions), 4 days per week for 8 weeks.
- mode of administration: each subject will perform all the exercises at home supervised for the investigator by phone.
- the target intensity: own weight
- who will be administering the intervention: investigator (physiotherapist)
- strategies used to monitor adherence: supervised for the investigator by phone.
Intervention code [1] 301041 0
Lifestyle
Comparator / control treatment
-No treatment in group control
-Exercise program in the exercise group
Control group
Active

Outcomes
Primary outcome [1] 305697 0
Change in the vertical jump test after the 8 weeks of gluteal muscle exercise program as assessed by 'My jump 2' app. This application measures the vertical jump in centimeters by filming the jump.
Timepoint [1] 305697 0
8 weeks later intervention commencement
Secondary outcome [1] 346192 0
Maintenance of the gain after 4 weeks of no gluteal exercises program. After this 4 weeks, a new measure on vertical jump will be made using “my jump 2 App”. Vertical jump will be measure in centimeters by filming the jump
Timepoint [1] 346192 0
4 weeks after primary timepoint

Eligibility
Key inclusion criteria
Healthy men and women, amateur athletes between 18-35 years old. They usually perform the vertical jump in their usual sport routine and they perform this sport activities 2-4 times per week around 2hours per session. In addition they must present a body mass index (BMI) between 19-25.
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subjects with a BMI out of the inclusion criteria (19-25). Also subjects with any symtomatic pathology affecting the lower limbs in the last year and/or painful injuries affecting cervical and lumbar spine in the last Six months.

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)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/05/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 10357 0
Spain
State/province [1] 10357 0
Madrid

Funding & Sponsors
Funding source category [1] 299344 0
University
Name [1] 299344 0
University of Alcalá (UAH)
Country [1] 299344 0
Spain
Primary sponsor type
University
Name
University of Alcalá (UAH)
Address
Plaza San Diego, s/n 28801 - Alcalá de Henares (Madrid) Spain
Country
Spain
Secondary sponsor category [1] 298622 0
None
Name [1] 298622 0
Address [1] 298622 0
Country [1] 298622 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 300250 0
Ethics committee address [1] 300250 0
Ethics committee country [1] 300250 0
Date submitted for ethics approval [1] 300250 0
07/05/2018
Approval date [1] 300250 0
Ethics approval number [1] 300250 0

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

Contacts
Principal investigator
Name 83050 0
Mrs Gerardo Vidal-Aragón Gil
Address 83050 0
Centro Médico Healthing
Calle de Serrano, 61.
28006
Madrid
Spain
Country 83050 0
Spain
Phone 83050 0
+34697373156
Fax 83050 0
Email 83050 0
[email protected]
Contact person for public queries
Name 83051 0
Gerardo Vidal-Aragón Gil
Address 83051 0
Centro Médico Healthing
Calle de Serrano, 61.
28006
Madrid
Spain
Country 83051 0
Spain
Phone 83051 0
+34697373156
Fax 83051 0
Email 83051 0
[email protected]
Contact person for scientific queries
Name 83052 0
Gerardo Vidal-Aragón Gil
Address 83052 0
Centro Médico Healthing
Calle de Serrano, 61.
28006
Madrid
Spain
Country 83052 0
Spain
Phone 83052 0
+34697373156
Fax 83052 0
Email 83052 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.