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Trial registered on ANZCTR


Registration number
ACTRN12618001768280
Ethics application status
Approved
Date submitted
24/09/2018
Date registered
26/10/2018
Date last updated
26/10/2018
Date data sharing statement initially provided
26/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
6-week-exercise programme for anterior pelvic tilt in healthy male adults with different anterior pelvic tilt: a controlled trial.
Scientific title
6-week-exercise programme for anterior pelvic tilt in healthy male adults: a controlled trial.
Secondary ID [1] 296207 0
None
Universal Trial Number (UTN)
Trial acronym
6week-TE-APT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior Pelvic Tilt 309245 0
Condition category
Condition code
Physical Medicine / Rehabilitation 308120 308120 0 0
Physiotherapy
Musculoskeletal 308121 308121 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group participants will be enrolled in a therapeutic programe that has been designed for the purpose of this study. It combines a repertory of standardized exercises that have been previpusly described in scientific literature. This programe of exercises will be conducted in a Hospital and delivered by a physiotherapist who supervise and control each therapeutic session during the intervention period.

Each participant will receive 45min therapy per session, in 18 separated sessions (three sessions per week, for 6 weeks). The programe involve 2 stages The first from week 1 to three and the second from the fourth to sixth week. The sessions are individual (not in group) and based on 1) active therapeutic exercise (80% of the intervention time) and 2) manual therapy (20% of intervention time). During the first stage all participants will perform 18 therapeutic active exercises and 5 manual therapy passive exercises. During the second stage 19 therapeutic active exercises and 5 manual therapy passive exercises. Exercise progression from the first to the second stage will involve exercise-difficulty-demand and incresed number of repetitions (bouts per exercise).


The therapeutic exercises includes: a) active lumbopelvic mobility, b) global hip muscle flexibility, c) hip muscle-strengthening exercises and d) lumbopelvic sensorimotor control exercises. Four flexibility-based-exercises will be developed during the first stage and 4 bouts and 15s position position maintenance, will be perform. In the second stage one flexibility exercise 4 bouts and 15s position maintenance will be perform. Mobility exercises during the first stage are 3 and 2-4 buts and 8 to 12 repetitions per bout will be perform; in the second stage 5 exercises and 2 to 3 bouts and 6, 8 or 12 repetitions will be performed. Both mobility flexibility exercises will be performed to self-perceived mid discomfor, no pain. Strengthening exercises for hip flexors include 5 exercises in the first stage and 4 in the second stage; the number of bouts are 2-3 during the first stage and 3 in the second stage and repetitions per bout will ranged from 6-8 during the first stage to 5-6 during the second stage. Exercises intensity-progression will be adjusted based on percent body weight bearing and/or the use of elastic bands. Posterior pelvic tilt drills will be included only during the second stage with three exercises that will be repeated from 2 two 5 times.

The manual therapy includes: soft tissue massage and central lumbar vertebral posterior-anterior mobilization. Soft tissue massage includes 3 exercises both during the first stage and second stage each one of them will be performed two bouts for 30s. Lumbopelvic mobilization include lumbar soft tissue massage and lumbar z-joint mobilization

During the intervention period all the participants will be encourage to continue with their habitual routines and regular activities including physical exercise.

Adherence to the therapeutic programe will be control by session attendance registry.
Intervention code [1] 312140 0
Rehabilitation
Comparator / control treatment
The participants in the control group voluntarily decide not to enroll in the exercise programe. During the intervention period they continue with their habitual routines and regular activities including physical exercise. During the final assessment session the participants will be asked if they had modified their habitual routines during the previous 6 weeks.
Control group
Active

Outcomes
Primary outcome [1] 307096 0
Functional anterior pelvic tilt in degreess will be assessed with a portable inclinometer while the participant walk at self comfortable speed for 60 seconds. Mean pelvic anterior tilt will be obtained from second 20 to 40. Before and after this time, the participant will be walking 20 seconds respectively but these data will not be used for further analysis.
Timepoint [1] 307096 0
Baseline, and after 6-weeks after intervention
Secondary outcome [1] 350673 0
Side bridge test right: side right torso endurance will be measured in seconds while the participant maintained right the side bridge position for as long as possible. The test involves static, isometric contractions of the right lateral muscles on each side of the trunk that stabilize the spine. The test is terminated once the client breaks the position or voluntary claudication.
Timepoint [1] 350673 0
Baseline, and after 6-weeks after intervention
Secondary outcome [2] 350674 0
Trunk extension endurance test: will be assesed in seconds while the participant maintain the horizontal position for as long as possible once testing commenced. The participant lie prone. The lower body was fixed to the table surface via straps at the ankles, knees, and hips for standard testing. The upper body (from just above the level of the anterior superior iliac crest) was off the surface of the plinth. Participants held their upper body off the end of the plinth. Once the participan falls below horizontal, the test is terminated.
Timepoint [2] 350674 0
Baseline, and after 6-weeks after intervention
Secondary outcome [3] 350675 0
Trunk flexion endurance test: The test timed a static, isometric contraction of the anterior muscles, stabilizing the spine until the individual exhibits fatigue and can no longer hold the assumed. The goal of the test is to hold a seated-backward-leaned position, 60-degree (hip-thigh), 90-degree hip,knees and second toe angle position, and flat-to-neutral spine position, while keeping the arms folded across the chest. for as long as possible without the benefit of the back support.
Timepoint [3] 350675 0
Baseline, and after 6-weeks after intervention
Secondary outcome [4] 350676 0
Side bridge test left: side left torso endurance will be measured in seconds while the participant maintained left the side bridge position for as long as possible. The test involves static, isometric contractions of the left lateral muscles on each side of the trunk that stabilize the spine. The test is terminated once the participant breaks the position or voluntary claudication.
Timepoint [4] 350676 0
Baseline, and after 6-weeks after intervention
Secondary outcome [5] 352961 0
Active Knee extension (AKE) Test: The subject lies supine on an examination table, head laid-back and arms folded across the chest. The lower limb not being tested will be secured to the table with a cloth strap across the thigh that is in a fully extended position.
The lower limb being tested with assistance from the subject is flexed 90 degrees. The subject then will held the position with the knee relaxed in flexion and the ankle in plantar flexion.
With the hip stabilized at 90 degrees flexion and the ankle relaxed in plantar flexion, the subject actively extend theknee while maintaining the 90 degrees hip flexion. Due to the simultaneous effort to continue knee extension a temporary myoclonus of alternating contraction and relaxation of the quadricep femoris and hamstring muscle groups occurred. At this time, the subject is then required not to force the leg past the point of initial, mild resistance. The subject is then told to slightly flex the knee until myoclonus stopped. At the first point of no shaking, the degree reading of knee flexion was observed and recorded.
The angle of knee flexion represented the point of hamstring tightness. Based ON RICHARD GAJDOSIK and GARY LUSIN Physical Theraphy Volume 63 / Number 7, July 1983 (1085-1088)
Timepoint [5] 352961 0
Baseline, and after 6-weeks after intervention

Eligibility
Key inclusion criteria
Male young, with no mobility limitation.
Participants will have anterior pelvic tilt (APT). As it is normal for healthy individuals to possess APT, the average angle of anterior pelvic tilt ranges will vary between them as well.
Minimum age
18 Years
Maximum age
40 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Low-back pain, have had recent back surgery, and/or are in the midst of an acute low-back flare-up.
Participants with strength or mobility deficiencies, where the individual cannot even lift the torso from a forward flexed position to a neutral position.
Participants with a high body mass, in which case it would be difficult for the Physiotherapist or Exercise Physiologist, to support the client's suspended upper-body weight.
Any neuromusculosqueletical issue at the hip or lower limb that represent a health risk for the participant.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealled
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants will decide the group they will be allocated.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
T-test to compare groups at baseline. Repeated measures anova for the inteaction: Time (pre-post intervention) and Group (control-intervention)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 20776 0
Spain
State/province [1] 20776 0
Madrid

Funding & Sponsors
Funding source category [1] 300403 0
Self funded/Unfunded
Name [1] 300403 0
Jurdan Mendiguchia-Sorabilla
Address [1] 300403 0
Poligono Industrial Barañain, Calle B, nave 23
Barañaín (Navarra, Spain)
PC: 31010
Country [1] 300403 0
Spain
Funding source category [2] 300759 0
Self funded/Unfunded
Name [2] 300759 0
Angel González de la Flor
Address [2] 300759 0
Hospital Universitario Quiron Salud MAdrid.
C/ Diego de Velázquez, 1
28223 Pozuelo de Alarcón, Madrid
Country [2] 300759 0
Spain
Primary sponsor type
Individual
Name
Jurdan Mendiguchia Sorabilla
Address
ZENTRUM, Poligono Industrial Barañain, Calle B, nave 23
Barañaín (Navarra Spain)
PC: 31010
Country
Spain
Secondary sponsor category [1] 300298 0
Individual
Name [1] 300298 0
Angel González de la Flor
Address [1] 300298 0
Hospital Universitario Quiron Salud MAdrid.
C/ Diego de Velázquez, 1
28223 Pozuelo de Alarcón, Madrid
Country [1] 300298 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301209 0
Comité de Ética del Hospital Universitario Fundación Jiménez Diaz
Ethics committee address [1] 301209 0
Hospital Universitario Fundación Jiménez Diaz
Avenida Reyes Católicos, 2. 28040. Madrid.
Spain
Ethics committee country [1] 301209 0
Spain
Date submitted for ethics approval [1] 301209 0
03/09/2018
Approval date [1] 301209 0
08/10/2018
Ethics approval number [1] 301209 0
PIC136-18_HUQM

Summary
Brief summary
This study will test the effectiveness of an intervention to decrease anterior pelvic tilt

Arm1: voluntary participants who decide to take part in a 6 week intervention programe which combines manual therapy and active exercises to decrease anterior pelvic tilt. 

Arm2: voluntary in-active group that continue with their habitual activities of daily living during the intervention period.

After the baseline test both groups will be advise to preserve their regular routines during the 6-week therapeutic intervention.
We hypothesized the intervention group will decrease anterior pelvic tilt more than the control group. The decreased anterior pelvic tilt in the intervention group will be proportional to the tilt magnitude, higher for those with higher anterior pelvic tilt and lower or nil for a lowered anterior pelvic tilt.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86230 0
Mr Jurdan Mendiguchia Sorabilla
Address 86230 0
Zentrum
Poligono industrial Barañain Calle B, Nave 23
31010 Barañain
Navarra
Country 86230 0
Spain
Phone 86230 0
+31 848 471 012
Fax 86230 0
Email 86230 0
jurdan27@hotmail.com
Contact person for public queries
Name 86231 0
Dr Angel Gonzalez de la Flor
Address 86231 0
Hospital Universitarion Quiron Salud Madrid
C/ Diego de Velázquez, 1
28223 Pozuelo de Alarcón,
Madrid,
Spain
Country 86231 0
Spain
Phone 86231 0
+31 914 521 900
Fax 86231 0
Email 86231 0
angelgdelaflor@gmail.com
Contact person for scientific queries
Name 86232 0
Dr Angel Gonzalez de la Flor
Address 86232 0
Hospital Universitarion Quiron Salud Madrid
c/ Diego de Velázquez, 1
28223 Pozuelo de Alarcón, Madrid
Country 86232 0
Spain
Phone 86232 0
+31 914 521 900
Fax 86232 0
Email 86232 0
angelgdelaflor@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Conflict with ethics approval and informed consent form.
What supporting documents are/will be available?
No other documents available
Summary results
No Results