- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06704568
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
90
Phase
- 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
-
-
-
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
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Having given birth within the last 1-6 months
- Being between the ages of 18-45
- Having a singleton pregnancy
- Willingness to participate in the study
- No history of physical or mental illness.
Exclusion Criteria:
- Those with postpartum anemia
- Those with postpartum respiratory tract infections
- Those whose newborns were hospitalized for any reason
- Those who gave birth to multiple babies
- Those with a history of chronic back pain
- Those with neurological symptoms
- 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 |
Intervention / Treatment |
|---|---|
|
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
|
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.
|
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.
|
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
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
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
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.
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)
May 20, 2024
Primary Completion (Actual)
October 11, 2024
Study Completion (Actual)
October 11, 2024
Study Registration Dates
First Submitted
October 11, 2024
First Submitted That Met QC Criteria
November 20, 2024
First Posted (Estimated)
November 26, 2024
Study Record Updates
Last Update Posted (Estimated)
November 26, 2024
Last Update Submitted That Met QC Criteria
November 20, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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