Core Exercise and Early Postpartum

November 20, 2024 updated by: Emine Merve Ersever, Ankara University

Respiratory-based Core Exercises in Early Postpartum Improve Abdominal Strength, Pulmonary Function, and Quality of Life

This study aimed to investigate the positive effects of abdominal core exercises and deep breathing exercises on abdominal muscle strength, pulmonary function, fatigue, and quality of life in the early postnatal period (1-6 months).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study will include 90 women who meet the inclusion criteria. Considering α < 0.05 and β = 0.2 (standard values that allow 90% power in sample size calculations), 3 groups of 30 participants were determined by considering at least 25 participants for each group based on an estimated 20% probability of loss during follow-up. 3 groups will be randomized as 1st group N=30 control group, 2nd group N=30 core exercise group, 3rd group N=30 respiratory exercises group. Unlike the control group; core exercises for 20 min-30 min 3 days a week for 8 weeks, respiratory exercises combined with core exercises for the respiratory exercises group: Starting with slow and controlled breathing exercises, it will be performed twice a day, 5 days a week for 8 weeks, 10 minutes, 5 seconds inhalation and 5 seconds exhalation, with a 10-second diaphragmatic breathing cycle (6 breaths/minute). The finger counting method will be recommended so that participants can easily follow the 5-second inhale and 5-second exhale cycles. The exercises can be done sitting or lying down. The individuals will be taught the differences between the two by switching between normal and deep breaths several times. The breathing exercises will be finished with relaxation exercises. The researchers created the core stabilization exercise program based on previous studies conducted by Litos (2014) and Horsley (2020) and in compliance with the guidelines of the Association of Obstetricians and Gynecologists (ACOG). The socio-demographic information and clinical characteristics of the participants in all three groups who meet the inclusion criteria and voluntarily agree to participate in the study will be questioned with the 'postpartum follow-up form'. Core endurance tests, respiratory tests, and fatigue assessments will be evaluated before and after the 8-week exercise and recorded on the form. For core measurement, three basic endurance tests will be performed, namely the trunk flexor endurance test and bilateral side bridge tests, following the Trunk Muscle Endurance Test protocol recommended by McGill et al. All movements will be performed after sufficient practice and the participants will be expected to try to maintain a static posture for as long as possible. Participants will be seated with their knees bent at 90◦ for the trunk flexor endurance test and their feet will be fixed. Then, participants will lean on the 60-degree trunk support with their hands clasped in front of their chests. Then, the trunk support will be pulled back 3 cm and they will be asked to maintain this posture for as long as possible. The test will be stopped when the participants lose their posture or their backs touch the support. Bilateral side bridge tests involve participants lying on their sides and lifting their trunks with their knees straight. One foot is placed in front of the other, hips are lifted and they will support their weight only with their elbows. The test will be stopped when the side-lying posture is lost or their hips drop to the mat. Respiratory tests will be performed with an analog spirometer. The maternal quality of life, and maternal perceived quality of life (MAPP-QOL) questionnaire was developed by Hill et al. (2006) and is based on the Quality of Life Index (QLI) of Ferrans et al. (1998). This questionnaire consists of thirty-eight items divided into five subcategories: Psychological/Baby (8 items), Socioeconomic (9 items), Relational/Partner (4 items), Relational/Family-Friends (9 items), and Health and Functioning (8 items). The internal consistency reliability (Cronbach's alpha) of the maternal quality of life questionnaire is R = 0.96 and the test and retest reliability at two-week intervals is R = 0.74. The level of fatigue perceived by individuals during the postpartum period will be recorded using the "Borg Fatigue Scale". Individuals will be asked to evaluate the level of fatigue they feel between 0 and 10. Individuals will be video-called at 2-week intervals to check their exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Haymana State Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Having given birth within the last 1-6 months
  2. Being between the ages of 18-45
  3. Having a singleton pregnancy
  4. Willingness to participate in the study
  5. No history of physical or mental illness.

Exclusion Criteria:

  1. Those with postpartum anemia
  2. Those with postpartum respiratory tract infections
  3. Those whose newborns were hospitalized for any reason
  4. Those who gave birth to multiple babies
  5. Those with a history of chronic back pain
  6. Those with neurological symptoms
  7. Those with cardiovascular and respiratory problems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: core exercise and early pospartum
Unlike the control group; core exercises for 20-30 minutes, 3 days a week for 8 weeks, and respiratory exercises combined with core exercises for the respiratory exercises group
Other: exercise
Unlike the control group; core exercises for 20-30 minutes, 3 days a week for 8 weeks, and respiratory exercises combined with core exercises for the respiratory exercises group: Slow and controlled breathing exercises will be performed starting with 5 seconds of inhalation and 5 seconds of exhalation twice a day for 10 minutes, 5 days a week for eight weeks, with a 10-second diaphragmatic breathing cycle (6 breaths/minute). The finger counting method will be recommended so that participants can easily follow the 5-second inhalation and 5-second exhalation cycles. The exercises can be done sitting or lying down. The individuals will be taught the differences between the two by switching between normal and deep breathing a few times. The respiratory exercises will be finished with relaxation exercises.
Experimental: breathing exercise
Slow and controlled breathing exercises will be performed starting with 5 seconds of inhalation and 5 seconds of exhalation twice a day for 10 minutes, 5 days a week for eight weeks, with a 10-second diaphragmatic breathing cycle (6 breaths/minute). The finger counting method will be recommended so that participants can easily follow the 5-second inhalation and 5-second exhalation cycles. The exercises can be done sitting or lying down. The individuals will be taught the differences between the two by switching between normal and deep breathing a few times. The respiratory exercises will be finished with relaxation exercises.
Other: exercise
Unlike the control group; core exercises for 20-30 minutes, 3 days a week for 8 weeks, and respiratory exercises combined with core exercises for the respiratory exercises group: Slow and controlled breathing exercises will be performed starting with 5 seconds of inhalation and 5 seconds of exhalation twice a day for 10 minutes, 5 days a week for eight weeks, with a 10-second diaphragmatic breathing cycle (6 breaths/minute). The finger counting method will be recommended so that participants can easily follow the 5-second inhalation and 5-second exhalation cycles. The exercises can be done sitting or lying down. The individuals will be taught the differences between the two by switching between normal and deep breathing a few times. The respiratory exercises will be finished with relaxation exercises.
Experimental: control
No application will be made to the control group.
Other: exercise
Unlike the control group; core exercises for 20-30 minutes, 3 days a week for 8 weeks, and respiratory exercises combined with core exercises for the respiratory exercises group: Slow and controlled breathing exercises will be performed starting with 5 seconds of inhalation and 5 seconds of exhalation twice a day for 10 minutes, 5 days a week for eight weeks, with a 10-second diaphragmatic breathing cycle (6 breaths/minute). The finger counting method will be recommended so that participants can easily follow the 5-second inhalation and 5-second exhalation cycles. The exercises can be done sitting or lying down. The individuals will be taught the differences between the two by switching between normal and deep breathing a few times. The respiratory exercises will be finished with relaxation exercises.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Static Trunk Endurance Test
Time Frame: 8 week
For endurance measurement,three core endurance tests were performed following the protocol of the TEMT. the trunk flexor endurance test and the bilateral side bridge tests. All movements were conducted after sufficient practice to eliminate any bias towards cognition, and the subjects aimed to maintain a static posture for as long as possible. The subjects sat with knees bent at 90° on the table for the trunk flexor endurance test, and their feet were held in place by a belt. Afterwards, they crossed their hands in front of their chests, leaned against the 60 degree trunk support, pulled the trunk support back 3 cm, and maintained this posture for as long as possible.The examination was stopped when the posture of lying on their side was lost or when their buttocks fell to the mat
8 week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
quality of life test
Time Frame: 8 week
The second outcome measure was the quality of life and controlling factors and fatique Participants' postpartum quality of life was evaluated with the Maternal Postpartum Quality of Life (MAPPQOL) [16]. Postpartum quality of life is a scale that is evaluated according to the perception of the mother and consists of five sub-dimensions and a total of 40 items. Sub-dimensions of the scale; kinship consists of family friend (nine items), socioeconomic (nine items), spouse (five items), health (eight items), and psychological (nine items) dimensions. The scale assesses how satisfied and important mothers feel at four to six weeks post discharge postpartum. The scale consists of two parts. In the first part, satisfaction with each item is questioned, and in the second part, the importance is questioned.
8 week
Pulmonary Function Test
Time Frame: 8 week
Pulmonary function test was done using a portable machine-a spirometer by COSMED technologies, USA. Variables that were used for this study included the following -forced vital capacity (L), forced expiratory volume in the first second (L), peak expiratory flow rate (L/s), and three tests were taken. The best value was entered in the datasheet
8 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 20, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 11, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 11, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E-51381736-771

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

6 mount

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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