NCT02268110

Brief Summary

The purpose of this study is to determine the effect of two different physiotherapeutic interventions (exercise therapy and/or abdominal binding) on the signs and symptoms of diastasis recti in post-partum women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Longer than P75 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

August 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 20, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

September 25, 2018

Status Verified

September 1, 2018

Enrollment Period

3 years

First QC Date

October 10, 2014

Last Update Submit

September 24, 2018

Conditions

Diastasis Recti And Weakness Of The Linea Alba

Keywords

diastasis rectiphysiotherapyexercise therapyabdominal binding

Outcome Measures

Primary Outcomes (1)

  • Change in Inter-Rectus Distance

    Measured using ultrasound imaging

    baseline, 12 weeks post intervention, 9 months post intervention

Secondary Outcomes (6)

  • Change in Abdominal Strength and Endurance

    baseline, 12 weeks post intervention, 9 months post intervention

  • Change in Body image

    baseline, 12 weeks post intervention, 9 months post intervention

  • Change in Lumbopelvic dysfunction

    baseline, 12 weeks post intervention, 9 months post intervention

  • Change in Urogynecological Complaints

    baseline, 12 weeks post intervention, 9 months post intervention

  • Change in Severity of Lumbopelvic and/or Abdominal Pain

    baseline, 12 weeks post intervention, 9 months post intervention

  • +1 more secondary outcomes

Study Arms (4)

Supervised exercise therapy

EXPERIMENTAL

Participants will receive 12 sessions with a physiotherapist where they will receive instructions on body mechanics, and be given a progressive abdominal exercise program

Other: Exercise therapy

Abdominal binding

EXPERIMENTAL

Participants will be fitted for an abdominal binder and asked to wear it for a period of 12 weeks.

Other: Abdominal binding

Exercise therapy and Abdominal Binding

EXPERIMENTAL

Participants will attend 12 sessions with a physiotherapist, and receive an abdominal binder

Other: Exercise therapyOther: Abdominal binding

Control

NO INTERVENTION

Participants will not receive an intervention during the study period

Interventions

Exercise therapyOTHER

Supervised exercise therapy with a 12 week progressive abdominal exercise home program for

Exercise therapy and Abdominal BindingSupervised exercise therapy
Abdominal bindingOTHER

Wearing an abdominal binder for 12 weeks

Abdominal bindingExercise therapy and Abdominal Binding

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • to 35 years old
  • given birth to their first child, vaginally, in the last three to four weeks
  • inter-rectus distance of two finger widths of greater on palpation during head lift

You may not qualify if:

  • history of persistent pain with intercourse prior to pregnancy
  • diagnosed with neurological impairments affecting the central nervous system or sacral nerves
  • diagnosed with connective tissue disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitation Sciences Institute

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Diastasis Recti And Weakness Of The Linea Alba

Interventions

Exercise Therapy

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • McLean Linda, PhD

    Queen's University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD candidate

Study Record Dates

First Submitted

October 10, 2014

First Posted

October 20, 2014

Study Start

August 1, 2014

Primary Completion

August 1, 2017

Study Completion

May 1, 2018

Last Updated

September 25, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)