NCT06975397

Brief Summary

A three-arm parallel-group randomized controlled trial was conducted with 90 women aged 23-42 years, 6-8 weeks postpartum. Participants were randomly assigned to one of three groups: no kinesiotaping (control), placebo kinesiotaping (no tension), and kinesiotaping with 50% tension. All participants followed the same exercise program. The primary outcome measure was the Diastasis Recti Index (DRI), assessed via ultrasound at baseline, 4 weeks, and 8 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
161

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

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

June 24, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2021

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 16, 2025

Completed
Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

1.4 years

First QC Date

April 24, 2025

Last Update Submit

May 7, 2025

Conditions

Keywords

Diastasis recti abdominisKinesio TapingPostpartumUltrasonographyExercise

Outcome Measures

Primary Outcomes (1)

  • Diastasis Recti Index (DRI)

    outcome: Diastasis Recti Index (DRI) was computed in order to normalize the ultrasound examination results. The DRA width was divided by waist circumference and multiplied by 100% to determine the changes in diastasis width at the navel line (DRIn), above the navel (DRIan), and under the navel (DRIun): DRI \[%\]=DRAw\[cm\]/(waist circumference \[cm\] )\*100% where * DRAw is the diastasis recti abdominis width at a given measurement line: at the navel, above the navel, and under the navel (respectively) * waist circumference was measured at the navel line in a given session.

    The effectiveness of Kinesio taping was assessed based on intergroup differences in the initial measurement values (DRI1) taken before the start of the project, the second measurement after 4 weeks (DRI2), and the third measurement after 8 weeks (DRI3).

Study Arms (3)

Group 1 - no taping - control group

SHAM COMPARATOR

The eligibility criteria for the study were: * aged between 25 and 45 years * first singleton pregnancy * natural childbirth * no medical contraindications for exercising and taping. The exclusion criteria were: * childbirth through cesarean section * more than eight weeks from natural childbirth * body mass index (BMI) over 35 kg/m2

Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Group 2 - taping without tension - placebo group

SHAM COMPARATOR

The eligibility criteria for the study were: * aged between 25 and 45 years * first singleton pregnancy * natural childbirth * no medical contraindications for exercising and taping. The exclusion criteria were: * childbirth through cesarean section * more than eight weeks from natural childbirth * body mass index (BMI) over 35 kg/m2

Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATIONOther: kinesio taping

Group 3 - taping at 50 % tension - tape group

ACTIVE COMPARATOR

The eligibility criteria for the study were: * aged between 25 and 45 years * first singleton pregnancy * natural childbirth * no medical contraindications for exercising and taping. The exclusion criteria were: * childbirth through cesarean section * more than eight weeks from natural childbirth * body mass index (BMI) over 35 kg/m2

Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATIONOther: kinesio taping

Interventions

This training and research project was conducted over eight weeks and started 6 - 8 weeks after natural childbirth. All study participants were included in the exercise program designed for postpartum females. Exercises included four sets that changed every two weeks and were held individually with a physiotherapist three times a week, every two to three days, for 45 minutes each unit. All participants performed breathing exercises, body posture correction, abdominal muscle strengthening exercises (transverse, oblique, and rectus abdominis muscles), and engaged other muscles to improve overall physical fitness.

Group 1 - no taping - control groupGroup 2 - taping without tension - placebo groupGroup 3 - taping at 50 % tension - tape group

The Kinesiology Tape used in this study has a European quality certificate (CE). Before the exercise program, on the day of the first ultrasound, participants had tapes placed on their abdomens. The tape length for each participant was 20 cm to ensure the ends were located on the lateral edges of the rectus abdominis muscles. Both ends of the tape were simultaneously attached to the abdomen, with two attached from the navel line upwards and one below it Each participant in the tape group was asked to breathe in using the abdominal muscles, and after a maximal stretch of the abdominal integuments, three tapes were attached at 50% tension or without tension. The taping procedure was repeated once per week, with the tapes attached for six days and removed at the end of the 6th day. The placebo and tape groups had a break on the 7th day

Group 2 - taping without tension - placebo groupGroup 3 - taping at 50 % tension - tape group

Eligibility Criteria

Age25 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe eligibility criteria for the study were: * aged between 25 and 45 years * first singleton pregnancy * natural childbirth * no medical contraindications for exercising and taping. The exclusion criteria were: * childbirth through cesarean section * more than eight weeks from natural childbirth * body mass index (BMI) over 35 kg/m2
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- aged between 25 and 45 years
  • first singleton pregnancy
  • natural childbirth
  • no medical contraindications for exercising and taping.

You may not qualify if:

  • \- childbirth through cesarean section
  • more than eight weeks from natural childbirth
  • body mass index (BMI) over 35 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehafit

Wroclaw, Lower Silesian Voivodeship, 53-661, Poland

Location

Related Publications (27)

  • Tuttle LJ, Fasching J, Keller A, Patel M, Saville C, Schlaff R, Walker A, Mason M, Gombatto SP 2018 Noninvasive Treatment of Postpartum Diastasis Recti Abdominis. Journal of Women's Health Physical Therapy 42(2): 65-75, doi:10.1097/jwh.0000000000000101

    BACKGROUND
  • Torbe D, Stolarek A, Lubkowska A, Torbe A. [Physical activity recommended in the early postpartum period]. Pomeranian J Life Sci. 2016;62(3):53-6. Polish.

    PMID: 29537766BACKGROUND
  • Rath AM, Attali P, Dumas JL, Goldlust D, Zhang J, Chevrel JP. The abdominal linea alba: an anatomo-radiologic and biomechanical study. Surg Radiol Anat. 1996;18(4):281-8. doi: 10.1007/BF01627606.

    PMID: 8983107BACKGROUND
  • Ptaszkowska L, Gorecka J, Paprocka-Borowicz M, Walewicz K, Jarzab S, Majewska-Pulsakowska M, Gorka-Dynysiewicz J, Jenczura A, Ptaszkowski K. Immediate Effects of Kinesio Taping on Rectus Abdominis Diastasis in Postpartum Women-Preliminary Report. J Clin Med. 2021 Oct 28;10(21):5043. doi: 10.3390/jcm10215043.

    PMID: 34768563BACKGROUND
  • Pawar PA, Yeole UL, Navale M, Patil K 2020 Effect of kinesiotaping on diastasis recti in post-partum women. Indian Journal of Public Health Research & Development 11(6):689-94, https://doi.org/10.37506/ijphrd.v11i6.9865

    BACKGROUND
  • O'Sullivan D, Bird SP 2011 Utilization of Kinesio Taping for Fascia Unloading. International Journal of Athletic Therapy and Training 16(4): 21-27, https://doi.org/10.1123/ijatt.16.4.21

    BACKGROUND
  • Mullins E, Sharma S, McGregor AH. Postnatal exercise interventions: a systematic review of adherence and effect. BMJ Open. 2021 Sep 30;11(9):e044567. doi: 10.1136/bmjopen-2020-044567.

    PMID: 34593482BACKGROUND
  • Mota P, Pascoal AG, Carita AI, Bo K. Normal width of the inter-recti distance in pregnant and postpartum primiparous women. Musculoskelet Sci Pract. 2018 Jun;35:34-37. doi: 10.1016/j.msksp.2018.02.004. Epub 2018 Feb 20.

    PMID: 29494833BACKGROUND
  • Mosiejczuk H, Lubinska A, Ptak M, Szylinska A, Kemicer-Chmielewska E, Laszczynska M, Rotter I. [Kinesiotaping as an interdisciplinary therapeutic method]. Pomeranian J Life Sci. 2016;62(1):60-6. Polish.

    PMID: 29533589BACKGROUND
  • Michalska A, Rokita W, Wolder D, Pogorzelska J, Kaczmarczyk K. Diastasis recti abdominis - a review of treatment methods. Ginekol Pol. 2018;89(2):97-101. doi: 10.5603/GP.a2018.0016.

    PMID: 29512814BACKGROUND
  • Mędrak A, Król T, Michałek-Król K, Dąbrowska-Galas M 2017 Kinesiotaping and the placebo effect. Family Medicine 20(4): 304-309, doi: 10.25121/MR.2017.20.4.304

    BACKGROUND
  • Mak DN, Au IP, Chan M, Chan ZY, An WW, Zhang JH, Draper D, Cheung RT. Placebo effect of facilitatory Kinesio tape on muscle activity and muscle strength. Physiother Theory Pract. 2019 Feb;35(2):157-162. doi: 10.1080/09593985.2018.1441936. Epub 2018 Feb 20.

    PMID: 29461139BACKGROUND
  • Mady MM 2018 Kinesiotaping Therapy Techniquesfor Treating Postpartum Rectus Diastases: A Comparative Study. IOSR Journal of Nursing and Health Science 7:67-74, doi: 10.9790/1959-0703026774

    BACKGROUND
  • Lim C, Park Y, Bae Y. The effect of the kinesio taping and spiral taping on menstrual pain and premenstrual syndrome. J Phys Ther Sci. 2013 Jul;25(7):761-4. doi: 10.1589/jpts.25.761. Epub 2013 Aug 20.

    PMID: 24259847BACKGROUND
  • Lemoncito MV, Paz-Pacheco E, Lim-Abrahan MA, Jasul G, Isip-Tan T, Sison CM 2010 Impact of Waist Circumference Measurement Variation on the Diagnosis of Metabolic Syndrome. Philippine Journal of Internal Medicine 48(3): 7-12

    BACKGROUND
  • Kirk B, Elliott-Burke T. The effect of visceral manipulation on Diastasis Recti Abdominis (DRA): A case series. J Bodyw Mov Ther. 2021 Apr;26:471-480. doi: 10.1016/j.jbmt.2020.06.007. Epub 2020 Aug 6.

    PMID: 33992284BACKGROUND
  • Kase K, Wallis J, Kase T 2013 Clinical Therapeutic Applications of the Kinesio Taping Method. Tokyo, Japan: Ken Ikai Co Ltd

    BACKGROUND
  • Keeler J, Albrecht M, Eberhardt LA, Horn L, Donnelly C, Lowe D 2012 Diastasis Recti Abdominis: A Survey of Women's Health Specialists for Current Physical Therapy Clinical Practice for Postpartum Women. Journal of Women's & Pelvic Health Physical Theray 36: 131-142, doi:10.1097/JWH.0B013E318276F35F

    BACKGROUND
  • Izydorczyk B, Walenista W, Kamionka A, Lizinczyk S, Ptak M. Connections Between Perceived Social Support and the Body Image in the Group of Women With Diastasis Recti Abdominis. Front Psychol. 2021 Aug 9;12:707775. doi: 10.3389/fpsyg.2021.707775. eCollection 2021.

    PMID: 34434150BACKGROUND
  • Inge P, Orchard JJ, Purdue R, Orchard JW. Exercise after pregnancy. Aust J Gen Pract. 2022 Mar;51(3):117-121. doi: 10.31128/AJGP-09-21-6181.

    PMID: 35224572BACKGROUND
  • Coldron Y, Stokes MJ, Newham DJ, Cook K. Postpartum characteristics of rectus abdominis on ultrasound imaging. Man Ther. 2008 May;13(2):112-21. doi: 10.1016/j.math.2006.10.001. Epub 2007 Jan 5.

    PMID: 17208034BACKGROUND
  • Boissonnault JS, Blaschak MJ. Incidence of diastasis recti abdominis during the childbearing year. Phys Ther. 1988 Jul;68(7):1082-6. doi: 10.1093/ptj/68.7.1082.

    PMID: 2968609BACKGROUND
  • Awad MA, Mahmoud AM, El-Ghazaly HM, Tawfeek RM 2017 Effect of Kinesio Taping on diastasis recti. Medical Journal Cairo University 85(6): 2289-2296

    BACKGROUND
  • Gluppe SB, Ellstrom Engh M, Bo K. Curl-up exercises improve abdominal muscle strength without worsening inter-recti distance in women with diastasis recti abdominis postpartum: a randomised controlled trial. J Physiother. 2023 Jul;69(3):160-167. doi: 10.1016/j.jphys.2023.05.017. Epub 2023 Jun 5.

    PMID: 37286390BACKGROUND
  • Gilleard WL, Brown JM. Structure and function of the abdominal muscles in primigravid subjects during pregnancy and the immediate postbirth period. Phys Ther. 1996 Jul;76(7):750-62. doi: 10.1093/ptj/76.7.750.

    PMID: 8677279BACKGROUND
  • Flament JB. [Functional anatomy of the abdominal wall]. Chirurg. 2006 May;77(5):401-7. doi: 10.1007/s00104-006-1184-5. German.

    PMID: 16703394BACKGROUND
  • Fernandes da Mota PG, Pascoal AG, Carita AI, Bo K. Prevalence and risk factors of diastasis recti abdominis from late pregnancy to 6 months postpartum, and relationship with lumbo-pelvic pain. Man Ther. 2015 Feb;20(1):200-5. doi: 10.1016/j.math.2014.09.002. Epub 2014 Sep 19.

    PMID: 25282439BACKGROUND

Related Links

MeSH Terms

Conditions

Motor Activity

Interventions

ExerciseDosage Forms

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaPharmaceutical PreparationsTechnology, PharmaceuticalInvestigative Techniques

Study Officials

  • Joanna Kmieć-Nowakowska, PhD

    Joanna Kmieć-Nowakowska Circa Feminae - terapia dla kobiet Ul. Abramowskiego 41 Wrocław nip 8981976347

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
None of the participants were aware of group allocations or the interventions used in each group according to CONSORT's diagram. Each subject was given the same exercises (instructor-led) and tested individually to maintain study blinding.
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
dr

Study Record Dates

First Submitted

April 24, 2025

First Posted

May 16, 2025

Study Start

June 24, 2020

Primary Completion

November 21, 2021

Study Completion

November 21, 2021

Last Updated

May 16, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

IPD will not be shared due to the lack of participant consent for data sharing and protect privacy in accordance with data protection regulations.

Locations