Diastasis Recti Abdominis (DRA)MTDRA-RCTNCT07861646
Manual Therapy for Diastasis Recti Abdominis
A study testing Standardized Manual Therapy Closure Protocol and Therapeutic Exercise for Deep Abdominal Activation in people with Diastasis Recti Abdominis (DRA) and Diastasis Recti Abdominis, run by Studio Vita at 1 site in Bosnia and Herzegovina.
Trial summary
This randomized, single-blind trial compared the effects of a standardized manual therapy closure protocol, delivered alone or combined with therapeutic exercise, with therapeutic exercise alone on inter-rectus distance (IRD) in women with diastasis recti abdominis (DRA). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Diastasis Recti Abdominis (DRA), Diastasis Recti Abdominis
- What is being tested?
- Standardized Manual Therapy Closure Protocol and Therapeutic Exercise for Deep Abdominal Activation
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteBosnia and Herzegovina
- Study dates
- 13 Feb 2026to 15 Feb 2026
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Female sex
- Age 18 years or older
- At least 4 months postpartum
- Diagnosed diastasis recti abdominis, defined as an inter-rectus distance (IRD) of at least 2 cm measured by ultrasound at one or more of the following levels: 2 cm above the umbilicus, at the umbilicus, and 2 cm below the umbilicus
- Able to understand the study procedures and provide written informed consent
- Able to attend assessments and follow the study protocol
Who cannot join
- Current pregnancy
- Abdominal surgery in the previous 4 months (including cesarean section)
- Umbilical or other abdominal hernia requiring surgical treatment
- Previous abdominoplasty or surgical repair of diastasis recti
- Neurological, rheumatological, or systemic disease affecting the musculoskeletal system
- Current oncological disease or treatment
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- Acute pain or medical conditions contraindicating exercise or abdominal loading
- Participation in another structured exercise or physiotherapy program targeting the abdominal wall or pelvic floor
- Cognitive or language barriers that prevent understanding of study instructions
Trial locations and contacts
1 site in 1 country.
Bosnia and Herzegovina1 site
APEIRON Research Institute
Banja Luka, 78000
About this study
Official title: Immediate Effects of a Standardized Manual Therapy Closure Protocol on Inter-Rectus Distance in Women With Diastasis Recti Abdominis: A Randomized Controlled Trial
This randomized, single-blind trial compared the effects of a standardized manual therapy closure protocol, delivered alone or combined with therapeutic exercise, with therapeutic exercise alone on inter-rectus distance (IRD) in women with diastasis recti abdominis (DRA). Sixty-four participants were allocated to one of three groups: a single session of the manual protocol alone; the same protocol followed immediately by therapeutic exercise; or a group performing therapeutic exercise three times per week for three months without the manual protocol. IRD was measured by ultrasound at three abdominal levels, under passive and active conditions, at diagnostic assessment (baseline), immediately after the intervention (manual therapy groups only), and after three months. Secondary outcomes included trunk mobility, respiratory chest excursion, and waist circumference.
Read the detailed description
This prospective, randomized, single-blind, parallel-group trial evaluated the effects of a standardized manual therapy protocol, delivered alone or combined with therapeutic exercise, compared with therapeutic exercise alone, on IRD in women with DRA. Participants were allocated to one of three groups: (1) a Protocol group (single session of standardized manual therapy targeting the thoracolumbar region and abdominal wall); (2) a Protocol+Exercise group (same manual protocol immediately followed by therapeutic exercise targeting deep abdominal muscle activation); or (3) an Exercise-only group of women with ultrasound-confirmed DRA who performed therapeutic exercise three times per week for three months without receiving the manual therapy protocol. All interventions in groups 1 and 2 were delivered by a single physiotherapist using a predefined technique sequence, with intensity adjusted to individual tissue tolerance. Participants with prior cesarean delivery in groups 1 and 2 received an additional protocol component addressing abdominal scar tissue.
IRD was assessed by B-mode ultrasound at three levels (2 cm above, at, and 2 cm below the umbilicus) under passive and active conditions. In groups 1 and 2, IRD was measured three times: at diagnostic assessment (baseline), immediately after the intervention, and after three months. In group 3, IRD was measured twice: at diagnostic assessment (baseline) and after three months of exercise. Secondary outcomes were trunk forward/lateral flexion, respiratory chest excursion, and waist circumference, measured at the same time points as IRD.
- Being tested
- Standardized Manual Therapy Closure Protocol, Therapeutic Exercise for Deep Abdominal Activation
- Keywords
- Inter-Rectus Distance, Manual Therapy, Abdominal Wall, Postpartum, Ultrasonography, Therapeutic Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Manual Therapy Closure ProtocolProcedure or surgery
Also called Manual Therapy Protocol
A single, individualized manual therapy session targeting the thoracolumbar region and the lateral and anterior abdominal wall, delivered per a predefined, standardized technique sequence. All sessions in the study were delivered by the same single physiotherapist. Intensity and duration were adjusted to individual tissue tolerance without altering the core treatment concept. Participants with prior cesarean delivery received an additional standardized component addressing abdominal wall scar tissue.
Therapeutic Exercise for Deep Abdominal ActivationBehavioural
Also called Abdominis Activation Exercise
A structured session of therapeutic exercise targeting activation of the deep abdominal muscles. Unlike the manual therapy protocol, which was delivered by a single physiotherapist, the exercise sessions were led by multiple physiotherapists and other trained staff.
| Study group | Role | What they receive |
|---|---|---|
| Protocol | Active comparator | Participants received a single individualized session of a standardized manual therapy closure protocol targeting the thoracolumbar region and the abdominal wall. Inter-rectus distance was measured by ultrasound at diagnostic assessment (baseline), immediately after the protocol, and after three months. Receives: Procedure: Standardized Manual Therapy Closure Protocol |
| Protocol + Exercise 3 months | Experimental | Participants received the same standardized manual therapy closure protocol immediately followed by a structured session of therapeutic exercise targeting deep abdominal muscle activation for three months. Inter-rectus distance was measured by ultrasound at diagnostic assessment (baseline), immediately after the intervention, and after three months. Receives: Procedure: Standardized Manual Therapy Closure Protocol; Behavioral: Therapeutic Exercise for Deep Abdominal Activation |
| Usual Exercise (3 months - Observation Only) | Active comparator | Participants in this arm had ultrasound-confirmed diastasis recti abdominis. They performed therapeutic exercise three times per week for three months without receiving the standardized manual therapy protocol. Inter-rectus distance was measured by ultrasound at diagnostic assessment (baseline) and after three months of exercise. Receives: Behavioral: Therapeutic Exercise for Deep Abdominal Activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-Rectus Distance (IRD)
Distance between the medial borders of the rectus abdominis muscles, measured by B-mode ultrasound imaging at three abdominal levels (2 cm above, at, and 2 cm below the umbilicus), under both passive (rest) and active (functional loading) conditions.
Measured: Immediately before and immediately after the single intervention session (approximately 30 minutes)
Secondary outcomes (4)
Trunk Forward Flexion
Fingertip-to-floor distance measured during maximal forward trunk flexion.
Measured: Immediately before and immediately after the single intervention session
Trunk Lateral Flexion
Fingertip-to-floor distance measured during maximal lateral trunk flexion, assessed bilaterally (left and right).
Measured: Immediately before and immediately after the single intervention session
Respiratory Chest Excursion
Circumferential chest measurement using a tape measure, assessed during maximal inspiration and expiration.
Measured: Immediately before and immediately after the single intervention session
Waist Circumference
Circumferential measurement of the waist at the level 2 cm below the umbilicus.
Measured: Immediately before and immediately after the single intervention session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start13 Feb 2026
- Primary completion15 Feb 2026
- Study completion15 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diastasis Recti Abdominis (DRA)Studies 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
- Model description
- Participants were randomly allocated to one of three parallel groups: (1) a Protocol group receiving a single session of standardized manual therapy alone; (2) a Protocol+Exercise group receiving the same manual therapy session immediately followed by therapeutic exercise; and (3) an Exercise-only group performing the same therapeutic exercise without the manual therapy protocol. Each participant received only one intervention type; outcomes were assessed immediately before and after the single intervention session.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Studio Vita
- Sponsor type
- University, hospital or other
- Collaborators
- Faculty of Health Studies, University of Rijeka, Pan-European University for Multidiscipline & Virtual Studies
- Responsible party
- Principal investigator, Ana Banić, Studio Vita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861646
- Sponsor's protocol ID
- DRA2026-01
- Other IDs
- I .3-89-1126
- Acronym
- MTDRA-RCT
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of a Standardized Manual Therapy Closure Protocol on Inter-Rectus Distance in Women With Diastasis Recti Abdominis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07861646
- Acronym / sponsor ID
- MTDRA-RCT / DRA2026-01
- Keywords
- Inter-Rectus Distance, Manual Therapy, Abdominal Wall, Postpartum, Ultrasonography, Therapeutic Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Studio VitaUniversity, hospital or other
- Collaborators
- Faculty of Health Studies, University of Rijeka, Pan-European University for Multidiscipline & Virtual Studies
- Study start
- 13 Feb 2026 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 15 Feb 2026 (actual)
- First posted
- 6 Oct 2026 (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.
This randomized, single-blind trial compared the effects of a standardized manual therapy closure protocol, delivered alone or combined with therapeutic exercise, with therapeutic exercise alone on inter-rectus distance (IRD) in women with diastasis recti abdominis (DRA). Sixty-four participants were allocated to one of three groups: a single session of the manual protocol alone; the same protocol followed immediately by therapeutic exercise; or a group performing therapeutic exercise three times per week for three months without the manual protocol. IRD was measured by ultrasound at three abdominal levels, under passive and active conditions, at diagnostic assessment (baseline), immediately after the intervention (manual therapy groups only), and after three months. Secondary outcomes included trunk mobility, respiratory chest excursion, and waist circumference.
Detailed description
This prospective, randomized, single-blind, parallel-group trial evaluated the effects of a standardized manual therapy protocol, delivered alone or combined with therapeutic exercise, compared with therapeutic exercise alone, on IRD in women with DRA. Participants were allocated to one of three groups: (1) a Protocol group (single session of standardized manual therapy targeting the thoracolumbar region and abdominal wall); (2) a Protocol+Exercise group (same manual protocol immediately followed by therapeutic exercise targeting deep abdominal muscle activation); or (3) an Exercise-only group of women with ultrasound-confirmed DRA who performed therapeutic exercise three times per week for three months without receiving the manual therapy protocol. All interventions in groups 1 and 2 were delivered by a single physiotherapist using a predefined technique sequence, with intensity adjusted to individual tissue tolerance. Participants with prior cesarean delivery in groups 1 and 2 received an additional protocol component addressing abdominal scar tissue.
IRD was assessed by B-mode ultrasound at three levels (2 cm above, at, and 2 cm below the umbilicus) under passive and active conditions. In groups 1 and 2, IRD was measured three times: at diagnostic assessment (baseline), immediately after the intervention, and after three months. In group 3, IRD was measured twice: at diagnostic assessment (baseline) and after three months of exercise. Secondary outcomes were trunk forward/lateral flexion, respiratory chest excursion, and waist circumference, measured at the same time points as IRD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants were randomly allocated to one of three parallel groups: (1) a Protocol group receiving a single session of standardized manual therapy alone; (2) a Protocol+Exercise group receiving the same manual therapy session immediately followed by therapeutic exercise; and (3) an Exercise-only group performing the same therapeutic exercise without the manual therapy protocol. Each participant received only one intervention type; outcomes were assessed immediately before and after the single intervention session.
| Arm | Type | Receives |
|---|---|---|
| Protocol | Active comparator | Procedure: Standardized Manual Therapy Closure ProtocolParticipants received a single individualized session of a standardized manual therapy closure protocol targeting the thoracolumbar region and the abdominal wall. Inter-rectus distance was measured by ultrasound at diagnostic assessment (baseline), immediately after the protocol, and after three months. |
| Protocol + Exercise 3 months | Experimental | Procedure: Standardized Manual Therapy Closure Protocol, Behavioral: Therapeutic Exercise for Deep Abdominal ActivationParticipants received the same standardized manual therapy closure protocol immediately followed by a structured session of therapeutic exercise targeting deep abdominal muscle activation for three months. Inter-rectus distance was measured by ultrasound at diagnostic assessment (baseline), immediately after the intervention, and after three months. |
| Usual Exercise (3 months - Observation Only) | Active comparator | Behavioral: Therapeutic Exercise for Deep Abdominal ActivationParticipants in this arm had ultrasound-confirmed diastasis recti abdominis. They performed therapeutic exercise three times per week for three months without receiving the standardized manual therapy protocol. Inter-rectus distance was measured by ultrasound at diagnostic assessment (baseline) and after three months of exercise. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Female sex
- Age 18 years or older
- At least 4 months postpartum
- Diagnosed diastasis recti abdominis, defined as an inter-rectus distance (IRD) of at least 2 cm measured by ultrasound at one or more of the following levels: 2 cm above the umbilicus, at the umbilicus, and 2 cm below the umbilicus
- Able to understand the study procedures and provide written informed consent
Key exclusion criteria (9 listed)
- Current pregnancy
- Abdominal surgery in the previous 4 months (including cesarean section)
- Umbilical or other abdominal hernia requiring surgical treatment
- Previous abdominoplasty or surgical repair of diastasis recti
- Neurological, rheumatological, or systemic disease affecting the musculoskeletal system
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 |
|---|---|---|
| Standardized Manual Therapy Closure ProtocolAlso: Manual Therapy ProtocolA single, individualized manual therapy session targeting the thoracolumbar region and the lateral and anterior abdominal wall, delivered per a predefined, standardized technique sequence. All sessions in the study were delivered by the same single physiotherapist. Intensity and duration were adjusted to individual tissue tolerance without altering the core treatment concept. Participants with prior cesarean delivery received an additional standardized component addressing abdominal wall scar tissue. | Procedure or surgery | Protocol, Protocol + Exercise 3 months |
| Therapeutic Exercise for Deep Abdominal ActivationAlso: Abdominis Activation ExerciseA structured session of therapeutic exercise targeting activation of the deep abdominal muscles. Unlike the manual therapy protocol, which was delivered by a single physiotherapist, the exercise sessions were led by multiple physiotherapists and other trained staff. | Behavioural | Protocol + Exercise 3 months, Usual Exercise (3 months - Observation Only) |
Primary outcome
Inter-Rectus Distance (IRD)
Time frame: Immediately before and immediately after the single intervention session (approximately 30 minutes)
Distance between the medial borders of the rectus abdominis muscles, measured by B-mode ultrasound imaging at three abdominal levels (2 cm above, at, and 2 cm below the umbilicus), under both passive (rest) and active (functional loading) conditions.
4 secondary outcomes
Trunk Forward Flexion
Time frame: Immediately before and immediately after the single intervention session
Trunk Lateral Flexion
Time frame: Immediately before and immediately after the single intervention session
Respiratory Chest Excursion
Time frame: Immediately before and immediately after the single intervention session
Waist Circumference
Time frame: Immediately before and immediately after the single intervention session
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 6 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Manual Therapy Closure Protocol and Therapeutic Exercise for Deep Abdominal Activation in people with Diastasis Recti Abdominis (DRA) and Diastasis Recti Abdominis, run by Studio Vita at 1 site in Bosnia and Herzegovina.
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 6 inclusion and 9 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 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bosnia and Herzegovina. 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-Rectus Distance (IRD) (time frame: Immediately before and immediately after the single intervention session (approximately 30 minutes)). 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 6 Oct 2026.