Effect of a Specific Exercise Program During Pregnancy on Diastasis Recti Abdominis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-30

Study Completion Date

2023-12-31

Brief Summary

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Diastasis Rectus abdominis is a common condition in pregnant and postpartum women, where the connective tissue between the two muscle bellies of the rectus abdominis muscle is stretched and weakened, causing an increased inter-rectus distance. Treatment of this condition aim to reduce the inter-rectus distance, and conservative treatment including therapeutic exercise is the primary treatment of choice. To date, there is no generally accepted protocol of therapeutic exercises for this condition, and the evidence as to which exercise modality is the most effective and feasible in reducing the inter-rectus distance in women presenting with diastasis rectus abdominis is both sparse and weak. As this condition occur during the last two trimesters of pregnancy and as there is a paucity of high-quality studies on a pregnant population, investigators will conduct a randomized controlled trial on the effect of a specific exercise program during pregnancy on diastasis rectus abdominis.

100 pregnant women in gestation week 25 presenting with diastasis rectus abdominis of ≥ 28 mm will be included. Participants will be allocated to either an intervention group or a control group by block randomization. The intervention group will participate in a 12-week specific exercise program, consisting of two group sessions and two self-managed sessions weekly. The control group will not participate in any exercise intervention; however, participants will be recommended to follow national guidelines for general exercise during pregnancy. Participants will be assessed prior to intervention, post intervention at gestation week 37, and 6 weeks, 6 and 12 months postpartum. The primary outcome measure will be change in the inter-rectus distance in mm, measured by two-dimensional ultrasonography.

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Detailed Description

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Conditions

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Diastasis Recti Abdominis Pregnancy Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This will be an exploratory, assessor blinded, randomized, controlled, parallel group trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

To ensure randomization to the two groups in the RCT, participants will, following baseline assessments, be allocated to the two groups by block randomization. Blocking will be masked and not stated in the protocol to avoid selection bias. The group allocation will be administrated by a research assistant, to ensure blinding of the assessor. This study is assessor blinded only, as participants and the physiotherapist running the intervention groups cannot be blinded.

Study Groups

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Intervention group

The participants in the intervention group will participate in a 12- week specific exercise programme led by an experienced women's health physiotherapist. These groups will take place at a private physiotherapy clinic twice a week. In addition, the participants will carry out a self-managed exercise program twice weekly for the same 12-week period. They will be provided with an exercise diary so that adherence to the intervention can be registered and monitored. This exercise diary will be sent to the participants once a week as an electronic questionnaire; this will ensure that the information recorded is standardized and that the research assistant can aid the participants to register their activity and encourage the participants to adhere to the intervention.

Group Type EXPERIMENTAL

Specific exercises

Intervention Type OTHER

Specific exercises which aims to contract the recti abdominis combined with functional exercises with the aim to contract all the layers of the anterior abdominal wall. Strengthening dosage will be applied with 3 sets, containing between 8 and 12 repetitions of maximal load.

Control group

The control group will not participate in any exercise intervention. The participants in the control group will be explained the importance of a control group in RCTs and will be recommended to continue with their normal activity levels. They will however, be recommended to follow national guidelines for general exercise during pregnancy and will receive information about these guidelines (15).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Specific exercises

Specific exercises which aims to contract the recti abdominis combined with functional exercises with the aim to contract all the layers of the anterior abdominal wall. Strengthening dosage will be applied with 3 sets, containing between 8 and 12 repetitions of maximal load.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* healthy pregnant women
* in gestation week 25
* Both primi- and multigravida women will be included, and there will be no limitations on number of fetuses

Exclusion Criteria

* pregnancies where exercise is contraindicated
* serious illnesses regarding both mother and fetus
* inability to understand Scandinavian languages
* failure to complete and present an informed consent form
* presence of chronic physical or mental illness incompatible with the intervention

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes