- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06302816
Effects of Tupler and Scoop Exercises in Diastasis Recti
March 4, 2024 updated by: Riphah International University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: imran amjad
- Phone Number: 03324390125
- Email: imran.amjad@riphah.edu.pk
Study Locations
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-
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Lahore, Pakistan, 05499
- Recruiting
- Innovative Health Concepts
-
Contact:
- hina gul gul
- Phone Number: 03214979172
- Email: hina.gul@riphah.edu.pk
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Principal Investigator:
- Rutaba Hussain, MSPT(WH)
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TUPLER exercises
|
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. |
Active Comparator: SCOOP EXERCISES
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Digital nylon calipers for inter recti distance (IRD)
Time Frame: 8th week
|
Digital nylon calipers 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
|
8th week
|
NPRS for low back pain
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
|
8th week
|
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
|
8th week
|
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
|
8th week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: hina gul gul, Riphah International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- Tung 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.
- Cavalli 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.
- Laframboise FC, Schlaff RA, Baruth M. Postpartum Exercise Intervention Targeting Diastasis Recti Abdominis. Int J Exerc Sci. 2021 Apr 1;14(3):400-409. eCollection 2021.
- Kaufmann 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.
- Sułkowski L, Matyja A. Diastasis recti abdominis (DRA): review of risk factors, diagnostic methods, conservative and surgical treatment. 2022.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 23, 2023
Primary Completion (Estimated)
August 1, 2024
Study Completion (Estimated)
September 1, 2024
Study Registration Dates
First Submitted
March 4, 2024
First Submitted That Met QC Criteria
March 4, 2024
First Posted (Actual)
March 12, 2024
Study Record Updates
Last Update Posted (Actual)
March 12, 2024
Last Update Submitted That Met QC Criteria
March 4, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/23/0580
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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