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Trial registered on ANZCTR


Registration number
ACTRN12617000556347
Ethics application status
Approved
Date submitted
21/02/2017
Date registered
20/04/2017
Date last updated
13/12/2019
Date data sharing statement initially provided
5/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Influence of the exercise on reduction of sacroiliac dysfunction in pregnancy
Scientific title
Influence of the exercise on reduction of sacroiliac dysfunction in pregnancy
Secondary ID [1] 291651 0
None
Universal Trial Number (UTN)
U1111-1193-3606
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sacroiliac dysfunction 302176 0
Condition category
Condition code
Physical Medicine / Rehabilitation 301786 301786 0 0
Physiotherapy
Reproductive Health and Childbirth 302300 302300 0 0
Antenatal care
Musculoskeletal 302301 302301 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study group will be trained on exercises to stabilize the sacroiliac joints by researchers. Training subjects will include four exercises to stabilise the sacroiliac joints which respondents performed at individual one-on-one session in hospital within a time period of 20 minutes (5 minutes each) two times a week until the end of pregnancy under the supervision of a physiotherapist.
Exercise 1. In four-legged position performed to exercise posterior pelvic tilt. The initial position would be four-legged relying on his hands and knees and pelvis in the neutral position. From neutral position of the pelvis performed to move posterior pelvic tilt and then return the pelvis to the neutral position.
Exercise 2. Stabilization of sacroiliac joints performed to the four-legged position. The initial position would be four-legged relying on his hands and knees, whereby the position of flexion of the knee and hip movement performed retroflexion thigh alternately with each upper leg.
Exercise 3. Stabilization of sacroiliac joints performed to and in a sitting position. The initial position would be sitting without back with feet on the ground. From the position of flexion of the knee and hip will be delivered movement anteflexion thigh but a shift in the thigh posterior direction towards sacroiliac joint. Exercise should be performed alternately by the right, and then the left foot.
Exercise 4. In the sitting position performed to exercise contraction of the gluteal muscles and posterior pelvic tilt. The starting position would have been sitting without back with feet on the ground. Then is performed the contraction of the gluteus and posterior pelvic tilt. Then would follow the return of the pelvis in the neutral position and relaxation gluteal muscles.
Every three weeks would be applied clinically functional tests: Patrik-Faber's test, distraction test, 4P test, palpation of ramus os pubis and test palpation of the dorsal ligaments for detecting sacroiliac dysfunction in pregnancy, VAS scale for detecting the intensity of pain and Quebec scale for assessing the degree of disability.
Intervention code [1] 297252 0
Rehabilitation
Intervention code [2] 297737 0
Treatment: Other
Comparator / control treatment
The control group continued to adhere to their normal lifestyle without education exercises to stabilize the sacroiliac joints.
Every three weeks would be applied clinically functional tests: Patrik-Faber's test, distraction test, 4P test, palpation of ramus os pubis and test palpation of the dorsal ligaments for detecting sacroiliac dysfunction in pregnancy, VAS scale for detecting the intensity of pain and Quebec scale for assessing the degree of disability.
Control group
Active

Outcomes
Primary outcome [1] 301186 0
To detect the effectiveness of therapeutic exercise in pregnancy on reducing sacroiliac dysfunction by clinical funcional test (Patrik-Faber's test, distraction test, 4P test, palpation of ramus os pubis and test palpation of the dorsal ligaments), VAS scale (for detecting the intensity of pain) and Quebec scale (for assessing the degree of disability)
Timepoint [1] 301186 0
At physiotherapy assessment every 3 weeks until the end of pregnancy
Secondary outcome [1] 331974 0
To determine the incidence of sacroiliac dysfunction during pregnancy in primiparas / multiparas and singleton / multifetal pregnancy by clinical funcional test (Patrik-Faber's test, distraction test, 4P test, palpation of ramus os pubis and test palpation of the dorsal ligaments)
Timepoint [1] 331974 0
At one physiotherapy assessment every 3 weeks until the end of pregnancy
Secondary outcome [2] 331975 0
Change in symptoms of sacroiliac dysfunction from baseline to end of exercise intervention in primiparas / multiparas and singleton / multifetal pregnancy by VAS scale (for detecting the intensity of pain) and Quebec scale (for assessing the degree of disability)
Timepoint [2] 331975 0
At physiotherapy assessment every 3 weeks until the end of pregnancy
Secondary outcome [3] 331976 0
To detect a corelation between therapeutic exercise with functional capabilities of pregnant women with sacroiliac dysfunction Quebec scale
Timepoint [3] 331976 0
At physiotherapy assessment every 3 weeks until the end of pregnancy

Eligibility
Key inclusion criteria
Primiparous / multiparous, singleton / multiple pregnancy, gestational age greater than 10 weeks and less than 34 weeks
Minimum age
25 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Surgical procedures in the area of the spine and pelvis, previous episodes of sacroiliac dysfunction before pregnancy, ankylosing spondylitis, and any other disease whose symptoms can cause symptoms of sacroiliac dysfunction

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)
After informed consent randomly selected espondents will be randomized into two groups.
Allocation concealment was done by central randomisation by phone/fax/computer selected
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For the incidence of sacroiliac dysfunction in pregnancy it will be used calculate the frequency. To determine the significance of the connection in frequencies would be used chi squared test. The corelation between the development of sacroiliac dysfunction and exercise in pregnancy and parity determined to Pearson's correlation coefficient. For the determination of the significance of the contribution of exercise and length of exercise in pregnancy would be used method of multiple regression analysis. In interpreting the results statistically significant would be considered the value of P <0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/06/2019
Actual
3/05/2017
Date of last participant enrolment
Anticipated
Actual
25/04/2018
Date of last data collection
Anticipated
19/04/2020
Actual
6/06/2018
Sample size
Target
374
Accrual to date
Final
500
Recruitment outside Australia
Country [1] 8684 0
Croatia
State/province [1] 8684 0
Zagreb

Funding & Sponsors
Funding source category [1] 295699 0
Hospital
Name [1] 295699 0
Clinical hospital Sveti Duh
Country [1] 295699 0
Croatia
Primary sponsor type
Hospital
Name
Clinical hospital Sveti Duh
Address
Clinical hospital Sveti Duh, Sveti Duh 64, 10 000 Zagreb
Country
Croatia
Secondary sponsor category [1] 294539 0
None
Name [1] 294539 0
None
Address [1] 294539 0
None
Country [1] 294539 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297005 0
Ethic Committee of Clinical hospital Sveti Duh
Ethics committee address [1] 297005 0
Ethics committee country [1] 297005 0
Croatia
Date submitted for ethics approval [1] 297005 0
10/01/2017
Approval date [1] 297005 0
08/02/2017
Ethics approval number [1] 297005 0
N/A

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

Contacts
Principal investigator
Name 72690 0
Mrs Manuela Filipec
Address 72690 0
Clinical hospital Sveti Duh, Sveti Duh 64, 10 000 Zagreb
Country 72690 0
Croatia
Phone 72690 0
+385913712561
Fax 72690 0
+385913712206
Email 72690 0
manuela.filipec@gmail.com
Contact person for public queries
Name 72691 0
Manuela Filipec
Address 72691 0
Clinical hospital Sveti Duh, Sveti Duh 64, 10 000 Zagreb
Country 72691 0
Croatia
Phone 72691 0
+385913712561
Fax 72691 0
+385913712206
Email 72691 0
manuela.filipec@gmail.com
Contact person for scientific queries
Name 72692 0
Manuela Filipec
Address 72692 0
Clinical hospital Sveti Duh, Sveti Duh 64, 10 000 Zagreb
Country 72692 0
Croatia
Phone 72692 0
+385913712561
Fax 72692 0
+385913712206
Email 72692 0
manuela.filipec@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
Data will not be available because of decision of Clinical hospital "Sveti Duh".


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
SourceTitleYear of PublicationDOI
EmbaseExpert advice about therapeutic exercise during pregnancy reduces the symptoms of sacroiliac dysfunction.2020https://dx.doi.org/10.1515/jpm-2020-0143
N.B. These documents automatically identified may not have been verified by the study sponsor.