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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]

None

Universal Trial Number (UTN)

U1111-1193-3606

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Sacroiliac dysfunction

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Reproductive Health and Childbirth

Antenatal care

Musculoskeletal

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]

Rehabilitation

Intervention code [2]

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]

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]

At physiotherapy assessment every 3 weeks until the end of pregnancy

Secondary outcome [1]

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]

At one physiotherapy assessment every 3 weeks until the end of pregnancy

Secondary outcome [2]

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]

At physiotherapy assessment every 3 weeks until the end of pregnancy

Secondary outcome [3]

To detect a corelation between therapeutic exercise with functional capabilities of pregnant women with sacroiliac dysfunction Quebec scale

Timepoint [3]

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]

Croatia

State/province [1]

Zagreb

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Clinical hospital Sveti Duh

Address [1]

Clinical hospital Sveti Duh, Sveti Duh 64, 10000 Zagreb

Country [1]

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]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethic Committee of Clinical hospital Sveti Duh

Ethics committee address [1]

Clinical hospital Sveti Duh, Sveti Duh 64, 10 000 Zagreb

Ethics committee country [1]

Croatia

Date submitted for ethics approval [1]

10/01/2017

Approval date [1]

08/02/2017

Ethics approval number [1]

N/A

Summary

Brief summary

Sacroiliac dysfunction during pregnancy leads to a reduction in quality and limit the activities of daily living pregnant women with incidence from 14% to 76.6%. The occurrence and development of sacroiliac dysfunction during pregnancy affect biomechanical and hormonal factors. Symptoms of sacroiliac dysfunction vary from minimal discomfort to harder disability during activities of daily living.
As during pregnancy due to hormonal changes disrupted ligaments function as a passive stabilizer of the pelvis is important to provide compensation by activation of muscles as active stabilizer. This is part of clinical management but without precise guidelines and standardised procedures. The tendency of this study is to investigate the role of exercise as a method of strengthening the muscles as active stabilizer sacroiliac joints during pregnancy in order to decrease the development of sacroiliac dysfunction.
Key words: pregnancy, exercise, sacroiliac dysfunction

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mrs Manuela Filipec

Address

Clinical hospital Sveti Duh, Sveti Duh 64, 10 000 Zagreb

Country

Croatia

Phone

+385913712561

Fax

+385913712206

[email protected]

Contact person for public queries

Name

Manuela Filipec

Address

Clinical hospital Sveti Duh, Sveti Duh 64, 10 000 Zagreb

Country

Croatia

Phone

+385913712561

Fax

+385913712206

[email protected]

Contact person for scientific queries

Name

Manuela Filipec

Address

Clinical hospital Sveti Duh, Sveti Duh 64, 10 000 Zagreb

Country

Croatia

Phone

+385913712561

Fax

+385913712206

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	Expert advice about therapeutic exercise during pregnancy reduces the symptoms of sacroiliac dysfunction.	2020	https://dx.doi.org/10.1515/jpm-2020-0143

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically