Diastasis RectiNCT06715059
Tele-rehabilitation in Women With Diastasis Recti Abdominis
A study testing Tele-rehabilitation exercise program and Home-based exercise program in people with Diastasis Recti and Diastasis Recti and Weakness of the Linea Alba, run by Atlas University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this randomized controlled study is to determine the effect of motor-control based telerehabilitation exercise program on inter-recti distance, abdominal endurance, pelvic floor dysfunction, and body-image perception in women with diastasis recti abdominis. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Diastasis Recti, Diastasis Recti and Weakness of the Linea Alba
- What is being tested?
- Tele-rehabilitation exercise program and Home-based exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 2 Nov 2021to 20 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Post- partum women (min 1 - max 5 years)
Who cannot join
- Having a neurological, orthopedical or any other condition which affect postural stability.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Istanbul Atlas University
Istanbul, KAgıthane
Atlas University
Istanbul, Kağıthane, 34413
About this study
Official title: Effects of Tele-rehabilitation on Inter-Recti Distance, Postural Balance, Abdominal Endurance and Pelvic Floor Functions
The aim of this randomized controlled study is to determine the effect of motor-control based telerehabilitation exercise program on inter-recti distance, abdominal endurance, pelvic floor dysfunction, and body-image perception in women with diastasis recti abdominis.
Researchers will compare the effects of motor-control-based telerehabilitation exercise program and conventional exercise programs in women with DRA.
Read the detailed description
Diastasis of recti abdominis (DRA) is defined as a separation of the two rectus abdominis muscles along the linea alba. Increased volume in the abdominal cavity, hormonal changes during pregnancy, neurodevelopmental differences, or abdominal wall laxity may caused. It is very common during pregnancy and may continue in the postnatal period. The loss of abdominal wall stability and weakened pelvic floor muscles may occur with DRA. The abdominal wall is one of the key point for body posture, trunk and pelvic stability. The core stability exercises, pelvic floor training and trunk muscle trainings are some of the exercise regimes options for management of DRA. However, in our best knowledge, there is no study in the literature that evaluates the effect of motor-control based telerehabilitation exercise program in women with DRA.
- Being tested
- Tele-rehabilitation exercise program, Home-based exercise program
- Keywords
- inter-recti distance, postural control, pelvic floor dysfunction, body-self relation, abdominal endurance
- Medical subject headings
- Diastasis Recti And Weakness Of The Linea Alba
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-rehabilitation exercise programOther
A progressive core stability exercise program will be performed based on motor control principles via an online platform.
Home-based exercise programOther
A core stability exercise program will be performed at home.
| Study group | Role | What they receive |
|---|---|---|
| Tele-rehab group | Experimental | The participants who performed exercise program via online platform. Receives: Other: Tele-rehabilitation exercise program |
| Home-based group | Experimental | The participants who performed exercise program in the home. Receives: Other: Home-based exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-recti distance
The subjects are assessed the inter-recti distance (IRD) in the supine position, knees bent and feet resting position on the table, the subjects is going to be asked to elevate the head and shoulders upwards until the inferior angles of the scapulae were just off the table.The subjects palpated the medial edges of RA muscles and IRD was measured using finger palpation in previously marked five-point: on the umbilicus, 5 cm, and 2 cm above and below the umbilicus
Measured: baseline
Inter-recti distance
The subjects are assessed the inter-recti distance (IRD) in the supine position, knees bent and feet resting position on the table, the subjects is going to be asked to elevate the head and shoulders upwards until the inferior angles of the scapulae were just off the table.The subjects palpated the medial edges of RA muscles and IRD was measured using finger palpation in previously marked five-point: on the umbilicus, 5 cm, and 2 cm above and below the umbilicus
Measured: after 8 weeks
Secondary outcomes (6)
Abdominal muscle endurance test
The static abdominal flexion endurance test is also performed once in the same position as the IRD test. The subjects are asked to raise their head and shoulders upwards until the scapulae cleared the table and keep the position as long as possible. The time was recorded as the score of the test.
Measured: baseline
Abdominal muscle endurance test
The static abdominal flexion endurance test is also performed once in the same position as the IRD test. The subjects are asked to raise their head and shoulders upwards until the scapulae cleared the table and keep the position as long as possible. The time was recorded as the score of the test.
Measured: After 8 weeks
Pelvic floor dysfunction
Every subject will complete the Turkish version of the short-form of Pelvic Floor Distress Inventory (PFDI-20) which consists of three subscales: the Pelvic Organ Prolapse Distress Inventory short-form (POPDI6), the Urogenital Distress Inventory short-form (UDI-6), and the Colorectal-Anal Distress Inventory short-form (CRADI-8) to assess prolapse and pelvic pressure, urinary symptoms, and bowel symptoms, respectively
Measured: baseline
Pelvic floor dysfunction
Every subject will complete the Turkish version of the short-form of Pelvic Floor Distress Inventory (PFDI-20) which consists of three subscales: the Pelvic Organ Prolapse Distress Inventory short-form (POPDI6), the Urogenital Distress Inventory short-form (UDI-6), and the Colorectal-Anal Distress Inventory short-form (CRADI-8) to assess prolapse and pelvic pressure, urinary symptoms, and bowel symptoms, respectively
Measured: After 8 weeks
Body-self relation
Every subject will complete the Turkish version of Multi-Dimensional Body-Self Relations Questionnaire.
Measured: baseline
Body-self relation
Every subject will complete the Turkish version of Multi-Dimensional Body-Self Relations Questionnaire.
Measured: After 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start2 Nov 2021
- Primary completion20 Dec 2022
- Study completion20 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diastasis RectiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilal Denizoğlu Külli, Atlas University
- Investigators
- Hilal DENİZOĞLU KÜLLİ, Principal investigator, İSTANBUL ATLAS ÜNİVERSİTESİ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715059
- Sponsor's protocol ID
- hdenizkulli
- Status last verified
- Nov 2024
- First submitted
- 21 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tele-rehabilitation on Inter-Recti Distance, Postural Balance, Abdominal Endurance and Pelvic Floor Functions
- ClinicalTrials.gov ID
- NCT06715059
- Acronym / sponsor ID
- hdenizkulli
- Keywords
- inter-recti distance, postural control, pelvic floor dysfunction, body-self relation, abdominal endurance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this randomized controlled study is to determine the effect of motor-control based telerehabilitation exercise program on inter-recti distance, abdominal endurance, pelvic floor dysfunction, and body-image perception in women with diastasis recti abdominis.
Researchers will compare the effects of motor-control-based telerehabilitation exercise program and conventional exercise programs in women with DRA.
Detailed description
Diastasis of recti abdominis (DRA) is defined as a separation of the two rectus abdominis muscles along the linea alba. Increased volume in the abdominal cavity, hormonal changes during pregnancy, neurodevelopmental differences, or abdominal wall laxity may caused. It is very common during pregnancy and may continue in the postnatal period. The loss of abdominal wall stability and weakened pelvic floor muscles may occur with DRA. The abdominal wall is one of the key point for body posture, trunk and pelvic stability. The core stability exercises, pelvic floor training and trunk muscle trainings are some of the exercise regimes options for management of DRA. However, in our best knowledge, there is no study in the literature that evaluates the effect of motor-control based telerehabilitation exercise program in women with DRA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tele-rehab group | Experimental | Other: Tele-rehabilitation exercise programThe participants who performed exercise program via online platform. |
| Home-based group | Experimental | Other: Home-based exercise programThe participants who performed exercise program in the home. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Post- partum women (min 1 - max 5 years)
Key exclusion criteria (1 listed)
- Having a neurological, orthopedical or any other condition which affect postural stability.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele-rehabilitation exercise programA progressive core stability exercise program will be performed based on motor control principles via an online platform. | Other | Tele-rehab group |
| Home-based exercise programA core stability exercise program will be performed at home. | Other | Home-based group |
Primary outcome
Inter-recti distance
Time frame: baseline
The subjects are assessed the inter-recti distance (IRD) in the supine position, knees bent and feet resting position on the table, the subjects is going to be asked to elevate the head and shoulders upwards until the inferior angles of the scapulae were just off the table.The subjects palpated the medial edges of RA muscles and IRD was measured using finger palpation in previously marked five-point: on the umbilicus, 5 cm, and 2 cm above and below the umbilicus
Inter-recti distance
Time frame: after 8 weeks
The subjects are assessed the inter-recti distance (IRD) in the supine position, knees bent and feet resting position on the table, the subjects is going to be asked to elevate the head and shoulders upwards until the inferior angles of the scapulae were just off the table.The subjects palpated the medial edges of RA muscles and IRD was measured using finger palpation in previously marked five-point: on the umbilicus, 5 cm, and 2 cm above and below the umbilicus
6 secondary outcomes
Abdominal muscle endurance test
Time frame: baseline
Abdominal muscle endurance test
Time frame: After 8 weeks
Pelvic floor dysfunction
Time frame: baseline
Pelvic floor dysfunction
Time frame: After 8 weeks
Body-self relation
Time frame: baseline
Body-self relation
Time frame: After 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilal DENİZOĞLU KÜLLİ principal investigator
İSTANBUL ATLAS ÜNİVERSİTESİ
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-rehabilitation exercise program and Home-based exercise program in people with Diastasis Recti and Diastasis Recti and Weakness of the Linea Alba, run by Atlas University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-recti distance (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.