DiastasisNCT06302816
Effects of Tupler and Scoop Exercises in Diastasis Recti
A study testing TUPLER exercises and SCOOP EXERCISES in people with Diastasis, run by Riphah International University at 1 site in Pakistan.
Trial summary
To compare the effects of tupler and scoop exercises on inter recti distance, low back pain, abdominal strength and urogynecological symptoms in diastasis. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Diastasis
- What is being tested?
- TUPLER exercises and SCOOP EXERCISES
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 23 Feb 2023to 1 Sep 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- BMI 25kg|m^2 to 30kg\m^2or greater
- multiparous women
- Participants included will be 3 months post-partum females
- Caesarean delivery who will have with the presence of DRA >2 finger width and >2cm
Who cannot join
- patients who had hernia
- trauma to bowel or bladder
- malignancies
- neurologic disease and its associated balance disorders,
- pelvic or abdominal surgery (except for a caesarean section) were considered as the exclusion criteria of this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Tupler and Scoop Exercises on Inter-recti-distance, Low Back Pain, Abdominal Strength and Urogynecological Symptoms in Diastasis Recti
To compare the effects of tupler and scoop exercises on inter recti distance, low back pain, abdominal strength and urogynecological symptoms in diastasis.
- Conditions
- Diastasis
- Being tested
- TUPLER exercises, SCOOP EXERCISES
- Keywords
- Diastasis recti abdominis, low back pain, Muscle strength, Pilates-Based Exercises, Static stretching.
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TUPLER exercisesOther
will be conducting tupler exercises, exercises that are designed to target core muscles in order to improve posture, regain core strength and reducing discomfort.
Each exercise will be repeated 10reps for 3 times on 3 days a week for 8 weeks.
SCOOP EXERCISESOther
will be required to complete scoop exercises basically deals with Pilates which is deep core and hip strengthening and stability through breathing patterns with the utilization of transversus abdominis muscle majorly. In each exercise participant will be asked to hold pelvic floor muscles for 8sec, then relax the muscles and count to 10, repeat I for 10 times each day for 3 days a week for 8weeks. Basic commands about the positing, activation and engagement of core along with breathing control were given to the subjects.
| Study group | Role | What they receive |
|---|---|---|
| TUPLER exercises | Experimental | Not described Receives: Other: TUPLER exercises |
| SCOOP EXERCISES | Active comparator | Not described Receives: Other: SCOOP EXERCISES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digital nylon calipers for inter recti distance
Digital nylon calipers for inter recti distance (IRD) used for the evaluatiopn of the DRA using tracing paper can be used preliminary assessment tool as well as a method for documentation of measurements of the inter recti in both males and females above the umbilicus with the abdominal muscles during contraction i.e in hook lying position. Digital Nylon Calipers demonstrated excellent inter-rater (ICC = 0.80 to 0.99) and It is the strongest tool for the assessment of the distasis recti
Measured: 8th week
Numeric pain rating scale
Numeric pain scale is an objective tool for the assessment of pain, rating from 0 to 10 according to the severity of pain. It is categorized as mild(1to3), moderate (4to6) and severe (7to10). It reliability is ICCs for the test-retest reliability were over 0.75
Measured: 8th week
Manual muscle testing for intra-abdominal strength
Manual muscle testing (MMT) is the objective assessment tool for the muscular strength measurement having grading of 0 to 5 according to the muscle response to an active resistance applied passively by some external force that can be therapist's hand. The intra-rater (ICC=0.95) and inter-rater (0.99) reliability (20) . 0 3 4 5 None Fair Good Normal No visible or palpable contraction Full ROM against gravity Full ROM against gravity, moderate resistance Full ROM against gravity, maximal resistance
Measured: 8th week
Short form Pelvic Floor Distress Inventory for Urogynaecological symptoms
Pelvic Floor Distress Inventory (PFDI-20) is a reliable instrument for evaluating the quality of life in women with pelvic dysfunction. They have been translated and validated in many languages. The study was aimed at validating the Estonian translations of the PFDI-20 and PFIQ-7 tools. Intra-class correlation coefficient (ICC) 0.765-0.969, p < 0.001
Measured: 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start23 Feb 2023
- Primary completion1 Aug 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for DiastasisStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- hina gul gul, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302816
- Sponsor's protocol ID
- REC/RCR&AHS/23/0580
- Status last verified
- Dec 2024
- First submitted
- 4 Mar 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gluppe S, Engh ME, Bo K. What is the evidence for abdominal and pelvic floor muscle training to treat diastasis recti abdominis postpartum? A systematic review with meta-analysis. Braz J Phys Ther. 2021 Nov-Dec;25(6):664-675. doi: 10.1016/j.bjpt.2021.06.006. Epub 2021 Jul 21.
PubMed 34391661Tung RC, Towfigh S. Diagnostic techniques for diastasis recti. Hernia. 2021 Aug;25(4):915-919. doi: 10.1007/s10029-021-02469-7. Epub 2021 Jul 27.
PubMed 34313855Cavalli M, Aiolfi A, Bruni PG, Manfredini L, Lombardo F, Bonfanti MT, Bona D, Campanelli G. Prevalence and risk factors for diastasis recti abdominis: a review and proposal of a new anatomical variation. Hernia. 2021 Aug;25(4):883-890. doi: 10.1007/s10029-021-02468-8. Epub 2021 Aug 6.
PubMed 34363190Laframboise FC, Schlaff RA, Baruth M. Postpartum Exercise Intervention Targeting Diastasis Recti Abdominis. Int J Exerc Sci. 2021 Apr 1;14(3):400-409. doi: 10.70252/GARZ3559. eCollection 2021.
PubMed 34055160Kaufmann RL, Reiner CS, Dietz UA, Clavien PA, Vonlanthen R, Kaser SA. Normal width of the linea alba, prevalence, and risk factors for diastasis recti abdominis in adults, a cross-sectional study. Hernia. 2022 Apr;26(2):609-618. doi: 10.1007/s10029-021-02493-7. Epub 2021 Oct 5.
PubMed 34609664Sułkowski L, Matyja A. Diastasis recti abdominis (DRA): review of risk factors, diagnostic methods, conservative and surgical treatment. 2022.
Radhakrishnan M, Ramamurthy K. Efficacy and Challenges in the Treatment of Diastasis Recti Abdominis-A Scoping Review on the Current Trends and Future Perspectives. Diagnostics (Basel). 2022 Aug 24;12(9):2044. doi: 10.3390/diagnostics12092044.
PubMed 36140446
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Tupler and Scoop Exercises on Inter-recti-distance, Low Back Pain, Abdominal Strength and Urogynecological Symptoms in Diastasis Recti
- ClinicalTrials.gov ID
- NCT06302816
- Acronym / sponsor ID
- REC/RCR&AHS/23/0580
- Conditions
- Diastasis
- Keywords
- Diastasis recti abdominis, low back pain, Muscle strength, Pilates-Based Exercises, Static stretching.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 12 Mar 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.
To compare the effects of tupler and scoop exercises on inter recti distance, low back pain, abdominal strength and urogynecological symptoms in diastasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TUPLER exercises | Experimental | Other: TUPLER exercises |
| SCOOP EXERCISES | Active comparator | Other: SCOOP EXERCISES |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI 25kg|m^2 to 30kg\m^2or greater
- multiparous women
- Participants included will be 3 months post-partum females
- Caesarean delivery who will have with the presence of DRA >2 finger width and >2cm
Key exclusion criteria (5 listed)
- patients who had hernia
- trauma to bowel or bladder
- malignancies
- neurologic disease and its associated balance disorders,
- pelvic or abdominal surgery (except for a caesarean section) were considered as the exclusion criteria of this study
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 exerciseswill be conducting tupler exercises, exercises that are designed to target core muscles in order to improve posture, regain core strength and reducing discomfort. Each exercise will be repeated 10reps for 3 times on 3 days a week for 8 weeks. | Other | TUPLER exercises |
| SCOOP EXERCISESwill be required to complete scoop exercises basically deals with Pilates which is deep core and hip strengthening and stability through breathing patterns with the utilization of transversus abdominis muscle majorly. In each exercise participant will be asked to hold pelvic floor muscles for 8sec, then relax the muscles and count to 10, repeat I for 10 times each day for 3 days a week for 8weeks. Basic commands about the positing, activation and engagement of core along with breathing control were given to the subjects. | Other | SCOOP EXERCISES |
Primary outcome
Digital nylon calipers for inter recti distance
Time frame: 8th week
Digital nylon calipers for inter recti distance (IRD) used for the evaluatiopn of the DRA using tracing paper can be used preliminary assessment tool as well as a method for documentation of measurements of the inter recti in both males and females above the umbilicus with the abdominal muscles during contraction i.e in hook lying position. Digital Nylon Calipers demonstrated excellent inter-rater (ICC = 0.80 to 0.99) and It is the strongest tool for the assessment of the distasis recti
Numeric pain rating scale
Time frame: 8th week
Numeric pain scale is an objective tool for the assessment of pain, rating from 0 to 10 according to the severity of pain. It is categorized as mild(1to3), moderate (4to6) and severe (7to10). It reliability is ICCs for the test-retest reliability were over 0.75
Manual muscle testing for intra-abdominal strength
Time frame: 8th week
Manual muscle testing (MMT) is the objective assessment tool for the muscular strength measurement having grading of 0 to 5 according to the muscle response to an active resistance applied passively by some external force that can be therapist's hand. The intra-rater (ICC=0.95) and inter-rater (0.99) reliability (20) . 0 3 4 5 None Fair Good Normal No visible or palpable contraction Full ROM against gravity Full ROM against gravity, moderate resistance Full ROM against gravity, maximal resistance
Short form Pelvic Floor Distress Inventory for Urogynaecological symptoms
Time frame: 8th week
Pelvic Floor Distress Inventory (PFDI-20) is a reliable instrument for evaluating the quality of life in women with pelvic dysfunction. They have been translated and validated in many languages. The study was aimed at validating the Estonian translations of the PFDI-20 and PFIQ-7 tools. Intra-class correlation coefficient (ICC) 0.765-0.969, p < 0.001
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 27 Dec 2024.
- Background: PubMed 34391661Gluppe S, Engh ME, Bo K. What is the evidence for abdominal and pelvic floor muscle training to treat diastasis recti abdominis postpartum? A systematic review with meta-analysis. Braz J Phys Ther. 2021 Nov-Dec;25(6):664-675. doi: 10.1016/j.bjpt.2021.06.006. Epub 2021 Jul 21.
- Background: PubMed 34313855Tung RC, Towfigh S. Diagnostic techniques for diastasis recti. Hernia. 2021 Aug;25(4):915-919. doi: 10.1007/s10029-021-02469-7. Epub 2021 Jul 27.
- Background: PubMed 34363190Cavalli M, Aiolfi A, Bruni PG, Manfredini L, Lombardo F, Bonfanti MT, Bona D, Campanelli G. Prevalence and risk factors for diastasis recti abdominis: a review and proposal of a new anatomical variation. Hernia. 2021 Aug;25(4):883-890. doi: 10.1007/s10029-021-02468-8. Epub 2021 Aug 6.
- Background: PubMed 34055160Laframboise FC, Schlaff RA, Baruth M. Postpartum Exercise Intervention Targeting Diastasis Recti Abdominis. Int J Exerc Sci. 2021 Apr 1;14(3):400-409. doi: 10.70252/GARZ3559. eCollection 2021.
- Background: PubMed 34609664Kaufmann RL, Reiner CS, Dietz UA, Clavien PA, Vonlanthen R, Kaser SA. Normal width of the linea alba, prevalence, and risk factors for diastasis recti abdominis in adults, a cross-sectional study. Hernia. 2022 Apr;26(2):609-618. doi: 10.1007/s10029-021-02493-7. Epub 2021 Oct 5.
- BackgroundSułkowski L, Matyja A. Diastasis recti abdominis (DRA): review of risk factors, diagnostic methods, conservative and surgical treatment. 2022.
- Background: PubMed 36140446Radhakrishnan M, Ramamurthy K. Efficacy and Challenges in the Treatment of Diastasis Recti Abdominis-A Scoping Review on the Current Trends and Future Perspectives. Diagnostics (Basel). 2022 Aug 24;12(9):2044. doi: 10.3390/diagnostics12092044.
- Individual participant dataSharing planned: No
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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.
hina gul gul principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TUPLER exercises and SCOOP EXERCISES in people with Diastasis, run by Riphah International University at 1 site 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 4 inclusion and 5 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 27 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 1 site 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 calipers for inter recti distance (time frame: 8th week). 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?
On the ClinicalTrials.gov record for NCT06302816, which also lists 7 linked publications.
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 27 Dec 2024.