Diastasis Rectus AbdominisNCT06530589
Effects of Tupler's Technique on the Management of Diastasis Rectus Abdominis.
A study testing Tupler's Technique and Traditional Exercises in people with Diastasis Rectus Abdominis, run by Riphah International University at 2 sites in Pakistan.
Trial summary
Diastasis Rectus Abdominis is the condition in which two abdominal muscles rectus abdominis separated and cause widening and thinning of Linea alba. The Tupler's Technique is Evidence Based intervention for the management of Diastasis Rectus Abdominis. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diastasis Rectus Abdominis
- What is being tested?
- Tupler's Technique and Traditional Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Aug 2024to 31 Dec 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 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primiparous and multiparous females (Vaginal delivery).
- Greater than and equal to 12 weeks post-partum
- Age limit will be18-30 years
- BMI under or equa to 29kg/m2
- Visiting with the complain of low back pain
- Diastasis of rectus abdominis at the level of umbilicus with mild, moderate and severe condition.
Who cannot join
- Other musculoskeletal disease (disc prolapse and disc bulge)
- Trauma of bowel and bladder
- Heart and respiratory conditions including sneezing and excessive coughing
- Any pelvic floor, abdominal and spinal surgery
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Allied Hospital Faisalabad
Faisalābad, Punjab Province, 38000
Madinah Teaching Hospital Faisalabad
Faisalābad, Punjab Province, 38000
About this study
Official title: Effects of Tupler's Technique on the Management of Diastasis Rectus Abdominis in Post-Partum Females.
Diastasis Rectus Abdominis is the condition in which two abdominal muscles rectus abdominis separated and cause widening and thinning of Linea alba. The Tupler's Technique is Evidence Based intervention for the management of Diastasis Rectus Abdominis. The purpose of this study is to see the Effectiveness of Tupler's Technique on the Management of Diastasis Rectus Abdomins in Post-Partum Females.
Read the detailed description
Literature suggest that during pregnancy due to hormonal changes such as increased in Relaxin, estrogen and progesterone level and also increased in the size of uterus affect the aponeurosis connection of abdominal muscles and due to these changes Diastasis Rectus Abdominis is common during pregnancy especially in third trimester and in the post-partum period. we can measure diastasis rectus abdominis by different methods such as palpatory, caliper and ultrasound. The condition can be mild (two fingers gap), moderate (two to three fingers gap) and severe (more than three fingers gap). The separation of greater than 2cm is considered as Diastasis Rectus Abdominis.
In this study effectiveness of Tupler's Technique will be assessed in post-partum diastasis rectus abdominis patients. Patients will have to wear diastasis rehab splints and then perform tupler's technique exercises. The mechanism behind this is when patients wear splint the splint will keep the connective tissues in narrow position for better healing and strengthening of muscles will be done by Tuper's Technique exercises and Diastasis of Rectus Abdominis willl be treated.
- Conditions
- Diastasis Rectus Abdominis
- Being tested
- Tupler's Technique, Traditional Exercises
- Keywords
- Diastasis Rectus Abdominis, Post-Partum Period, Tupler's Technique, Abdominal Strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tupler's TechniqueOther
Patient will wear diastasis rehab splint and will follow Tupler's techniqe protocol for 6 weeks. In the first 2 weeks both elevator and contracting exercises will be performed and after 2 weeks in the 3rd week only contracting exercises will be perform and for these exercises we divide abdomen into 6 floors and will patient have to contract her tummy towards the 3rd to 5th floor in first week, towards the 4th to 5th floor in 2nd week and from 5th to 6th floor in the 3rd week. in the wek 4 to week 6 head lifts will also be started along with contracting exercises from 5th to 6th floor.
Traditional ExercisesOther
The traditional treatment includes traditional abdominal exercises that patient will be perform for 6 weeks and three times per week with 15 repetitions of each exercise. These exercises includes posterior pelvic tilt' static abdominal contractions', reverse sit up exercise, kegals, russian twist , trunk twist and reverse trunk twist.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Group | Experimental | Tupler's Technique will be applied to this group. This technique includes Tupler's technique exercises and patients will also wears diastasis rehab splints. Patients will perform seated isometric exercises (elevator and contracting exercises) after wearing diastasis rehab splint. Repetitions of exercises will be 100 and whole intervention will be provided for 6 weeks. Receives: Other: Tupler's Technique |
| Control Group | Active comparator | Traditional treatment protocol will be applied to this group that includes traditional exercises for diastasis rectus abdominis and this protocol will be followed 3 times per week for 6 weeks. Receives: Other: Traditional Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digital nylon caliper to measure inter-recti Distance
Digital nylon caliper is the valid and reliable instrument to measure the inter-recti distance and inter-recti distance will be measured at three levels. at the level of umbilicus, 4.5cm above umbilicus and 4.5cm below umbilicus.
Measured: Before intervention, after 3 weeks and after 6 weeks.
Oswestry low bac pain disability Questionnaire
This is a valid tool to assess back pain and this questionnaire has 10 sections and we grade level of disability according to grading criteria. 0-4shows no disability, 5-14 shows mild disability, and 15-24 shows moderate disability, and 25-34 shows severe disability and grade 35-50 means completely disabled.
Measured: Before intervention, after 3 weeks and after 6 weeks.
Numeric Pain rating scale
By using this scale we will measure the intensity of back pain. i scores pain from 0-10. 0 means no pain, 5 means moderate pain and 10 means severe pain.
Measured: Before intervention, after 3 weeks and after 6 weeks.
Maternal post-partum quality of life instrument (MPQOL-I)
This questionnaire has 5 domains. psychological, reltion with family and friends, relation with spouse, socioeconomic and health related domain and we can assess every domain of female life.
Measured: Before intervention, after 3 weeks and after 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start1 Aug 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diastasis Rectus AbdominisStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- There will be comparison between two groups, experimental and control
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huma Riaz, PhD, Study chair, Riphah International University, Islamabad, PakistanAqsa Shahid, MSPT*, Principal investigator, Riphah International University, Islamabad, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530589
- Sponsor's protocol ID
- Aqsa Shahid
- Status last verified
- Feb 2025
- First submitted
- 28 Jul 2024
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tupler's Technique on the Management of Diastasis Rectus Abdominis in Post-Partum Females.
- ClinicalTrials.gov ID
- NCT06530589
- Acronym / sponsor ID
- Aqsa Shahid
- Conditions
- Diastasis Rectus Abdominis
- Keywords
- Diastasis Rectus Abdominis, Post-Partum Period, Tupler's Technique, Abdominal Strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 31 Jul 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.
Diastasis Rectus Abdominis is the condition in which two abdominal muscles rectus abdominis separated and cause widening and thinning of Linea alba. The Tupler's Technique is Evidence Based intervention for the management of Diastasis Rectus Abdominis. The purpose of this study is to see the Effectiveness of Tupler's Technique on the Management of Diastasis Rectus Abdomins in Post-Partum Females.
Detailed description
Literature suggest that during pregnancy due to hormonal changes such as increased in Relaxin, estrogen and progesterone level and also increased in the size of uterus affect the aponeurosis connection of abdominal muscles and due to these changes Diastasis Rectus Abdominis is common during pregnancy especially in third trimester and in the post-partum period. we can measure diastasis rectus abdominis by different methods such as palpatory, caliper and ultrasound. The condition can be mild (two fingers gap), moderate (two to three fingers gap) and severe (more than three fingers gap). The separation of greater than 2cm is considered as Diastasis Rectus Abdominis.
In this study effectiveness of Tupler's Technique will be assessed in post-partum diastasis rectus abdominis patients. Patients will have to wear diastasis rehab splints and then perform tupler's technique exercises. The mechanism behind this is when patients wear splint the splint will keep the connective tissues in narrow position for better healing and strengthening of muscles will be done by Tuper's Technique exercises and Diastasis of Rectus Abdominis willl be treated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- There will be comparison between two groups, experimental and control
| Arm | Type | Receives |
|---|---|---|
| Interventional Group | Experimental | Other: Tupler's TechniqueTupler's Technique will be applied to this group. This technique includes Tupler's technique exercises and patients will also wears diastasis rehab splints. Patients will perform seated isometric exercises (elevator and contracting exercises) after wearing diastasis rehab splint. Repetitions of exercises will be 100 and whole intervention will be provided for 6 weeks. |
| Control Group | Active comparator | Other: Traditional ExercisesTraditional treatment protocol will be applied to this group that includes traditional exercises for diastasis rectus abdominis and this protocol will be followed 3 times per week for 6 weeks. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Primiparous and multiparous females (Vaginal delivery).
- Greater than and equal to 12 weeks post-partum
- Age limit will be18-30 years
- BMI under or equa to 29kg/m2
- Visiting with the complain of low back pain
Key exclusion criteria (4 listed)
- Other musculoskeletal disease (disc prolapse and disc bulge)
- Trauma of bowel and bladder
- Heart and respiratory conditions including sneezing and excessive coughing
- Any pelvic floor, abdominal and spinal surgery
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 |
|---|---|---|
| Tupler's TechniquePatient will wear diastasis rehab splint and will follow Tupler's techniqe protocol for 6 weeks. In the first 2 weeks both elevator and contracting exercises will be performed and after 2 weeks in the 3rd week only contracting exercises will be perform and for these exercises we divide abdomen into 6 floors and will patient have to contract her tummy towards the 3rd to 5th floor in first week, towards the 4th to 5th floor in 2nd week and from 5th to 6th floor in the 3rd week. in the wek 4 to week 6 head lifts will also be started along with contracting exercises from 5th to 6th floor. | Other | Interventional Group |
| Traditional ExercisesThe traditional treatment includes traditional abdominal exercises that patient will be perform for 6 weeks and three times per week with 15 repetitions of each exercise. These exercises includes posterior pelvic tilt' static abdominal contractions', reverse sit up exercise, kegals, russian twist , trunk twist and reverse trunk twist. | Other | Control Group |
Primary outcome
Digital nylon caliper to measure inter-recti Distance
Time frame: Before intervention, after 3 weeks and after 6 weeks.
Digital nylon caliper is the valid and reliable instrument to measure the inter-recti distance and inter-recti distance will be measured at three levels. at the level of umbilicus, 4.5cm above umbilicus and 4.5cm below umbilicus.
Oswestry low bac pain disability Questionnaire
Time frame: Before intervention, after 3 weeks and after 6 weeks.
This is a valid tool to assess back pain and this questionnaire has 10 sections and we grade level of disability according to grading criteria. 0-4shows no disability, 5-14 shows mild disability, and 15-24 shows moderate disability, and 25-34 shows severe disability and grade 35-50 means completely disabled.
Numeric Pain rating scale
Time frame: Before intervention, after 3 weeks and after 6 weeks.
By using this scale we will measure the intensity of back pain. i scores pain from 0-10. 0 means no pain, 5 means moderate pain and 10 means severe pain.
Maternal post-partum quality of life instrument (MPQOL-I)
Time frame: Before intervention, after 3 weeks and after 6 weeks.
This questionnaire has 5 domains. psychological, reltion with family and friends, relation with spouse, socioeconomic and health related domain and we can assess every domain of female life.
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 21 Feb 2025.
- Individual participant dataSharing planned: No
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Risk Factors and Exercise Effects on Abdominal Separation in Seniors
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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.
Huma Riaz, PhD study chair
Riphah International University, Islamabad, Pakistan
Aqsa Shahid, MSPT* principal investigator
Riphah International University, Islamabad, Pakistan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tupler's Technique and Traditional Exercises in people with Diastasis Rectus Abdominis, run by Riphah International University at 2 sites in Pakistan.
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 4 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 21 Feb 2025. 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 Pakistan. 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?
Digital nylon caliper to measure inter-recti Distance (time frame: Before intervention, after 3 weeks and after 6 weeks.). The study lists 4 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 21 Feb 2025.