NCT06302816

Brief Summary

To compare the effects of tupler and scoop exercises on inter recti distance, low back pain, abdominal strength and urogynecological symptoms in diastasis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 23, 2023

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 4, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

1.4 years

First QC Date

March 4, 2024

Last Update Submit

December 20, 2024

Conditions

Keywords

Diastasis recti abdominislow back painMuscle strengthPilates-Based ExercisesStatic stretching.

Outcome Measures

Primary Outcomes (4)

  • 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

    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

    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

    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

    8th week

Study Arms (2)

TUPLER exercises

EXPERIMENTAL
Other: TUPLER exercises

SCOOP EXERCISES

ACTIVE COMPARATOR
Other: SCOOP EXERCISES

Interventions

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.

TUPLER 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.

SCOOP EXERCISES

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsDIASTASIS
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • patients who had hernia
  • trauma to bowel or bladder
  • malignancies
  • neurologic disease and its associated balance disorders,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Innovative Health Concepts

Lahore, 05499, Pakistan

Location

Related Publications (7)

  • 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.

    PMID: 34391661BACKGROUND
  • 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.

    PMID: 34313855BACKGROUND
  • 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.

    PMID: 34363190BACKGROUND
  • Laframboise 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.

    PMID: 34055160BACKGROUND
  • 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.

    PMID: 34609664BACKGROUND
  • Sułkowski L, Matyja A. Diastasis recti abdominis (DRA): review of risk factors, diagnostic methods, conservative and surgical treatment. 2022.

    BACKGROUND
  • 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.

    PMID: 36140446BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • hina gul gul

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2024

First Posted

March 12, 2024

Study Start

February 23, 2023

Primary Completion

August 1, 2024

Study Completion

September 1, 2024

Last Updated

December 27, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations