NCT05811299

Brief Summary

Diastasis recti is an increase in the gap between the rectus abdominis muscles at the midline caused by anterior abdominal wall weakening. The aim of this study is to evaluate the effects of abdominal exercises with and without Kinesio taping on abdominal strength of females with diastasis recti for their better quality of life. This study will be randomized controlled trial .Subjects with diastasis recti meeting the predetermined inclusion and exclusion criteria will be requested to participate in the study via informed consent. Non probability convenient sampling technique will be used. 46 participants will be randomly allocated to either Group A or Group B .Group A will be treated with Kinesio Taping applied in a criss -cross design for consecutive 3 days with 1 day gap after taping will do abdominal exercises.Group B will be treated with above mentioned abdominal exercises for 1 month. Pre and post assessment of diastasis recti and abdominal strength will be done using caliper method and manual muscle test and quality of life will be assessed by MAPP-QOL questionnaire.Jinnah Hospital will be the setting and SPSS software will be used.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

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

November 20, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 13, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

8 months

First QC Date

March 31, 2023

Last Update Submit

December 26, 2023

Conditions

Keywords

ChildbirthIsometric ContractionsKinesio TapePostpartum WomenRectus Abdominus.

Outcome Measures

Primary Outcomes (3)

  • Caliper Method

    Rectus abdominis diastasis will be measured during the postpartum period with a high degree of reliability when a dial callper is used.

    4 weeks

  • MMT

    Manual muscle testing (MMT) based on a grading system of 0 to 5.To check the abdminal strength

    4weeks

  • MAPP QOL

    The Maternal Postpartum Quality of Life (MAPP-QOL) instrument consisted of 41 item to check quality of life

    4 weeks

Study Arms (2)

Abdominal Exercises and KT intervention

EXPERIMENTAL

(Group A ) will receive kinesio taping with abdominal exercises. 8 sessions for 4 weeks and 2 session will be given in a week.

Other: Kinesio tapingOther: Abominal exercises

Abdominal exercises

ACTIVE COMPARATOR

(Group B) will receive abdominal exercises 8 sessions for 4 weeks and 2 session will be given in a week.

Other: Abominal exercises

Interventions

Total of 8 sessions for 4 weeks 2 sessions in a week.

Abdominal Exercises and KT intervention

Total of 8 sessions for 4 weeks 2 sessions in a week.

Abdominal Exercises and KT interventionAbdominal exercises

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales with diastasis recti.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Post natal till 6 months
  • Rectus abdominis diastasis \> 2.7 cm at umbilicus
  • Age 18 to 40

You may not qualify if:

  • Pregnant female
  • Hernia
  • Females with physical and mental illness
  • Females with any other medical condition like cardiorespiratory diseases
  • History of malignancy
  • Urogynecologic disorders
  • Females suffering from other gynecological issues such as endometriosis
  • Polycystic ovaries syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinnah Hospital,Gynae department

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (4)

  • Gursen C, Inanoglu D, Kaya S, Akbayrak T, Baltaci G. Effects of exercise and Kinesio taping on abdominal recovery in women with cesarean section: a pilot randomized controlled trial. Arch Gynecol Obstet. 2016 Mar;293(3):557-65. doi: 10.1007/s00404-015-3862-3. Epub 2015 Sep 2.

    PMID: 26329802BACKGROUND
  • Gluppe SB, Engh ME, Bo K. Immediate Effect of Abdominal and Pelvic Floor Muscle Exercises on Interrecti Distance in Women With Diastasis Recti Abdominis Who Were Parous. Phys Ther. 2020 Aug 12;100(8):1372-1383. doi: 10.1093/ptj/pzaa070.

    PMID: 32302393BACKGROUND
  • 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
  • Boxer S, Jones S. Intra-rater reliability of rectus abdominis diastasis measurement using dial calipers. Aust J Physiother. 1997;43(2):109-114. doi: 10.1016/s0004-9514(14)60405-0.

    PMID: 11676678BACKGROUND

Study Officials

  • Sabiha Arshad, Mphill

    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 31, 2023

First Posted

April 13, 2023

Study Start

November 20, 2022

Primary Completion

July 30, 2023

Study Completion

August 1, 2023

Last Updated

December 27, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations