Postpartum AnxietyNCT06704568
Core Exercise and Early Postpartum
A study testing exercise in people with Postpartum Anxiety and Exercise Overtraining, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Anxiety, Exercise Overtraining, Fatigue
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2024to 11 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Postpartum Anxiety, Exercise Overtraining, Fatigue
- Being tested
- exercise
- Keywords
- core stabilitation, fatigue, pospartum, breathing exercises
- Medical subject headings
- Overtraining Syndrome, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| core exercise and early pospartum | Experimental | 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 Receives: Other: exercise |
| breathing exercise | Experimental | 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. Receives: Other: exercise |
| control | Experimental | No application will be made to the control group. Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static Trunk Endurance Test
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
Measured: 8 week
Secondary outcomes (2)
quality of life test
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.
Measured: 8 week
Pulmonary Function Test
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
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start20 May 2024
- Primary completion11 Oct 2024
- Study completion11 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- 1st group N=30 control group, 2nd group N=30 core exercise group, 3rd group N=30 breathing exercises group will be randomly divided into 3 groups.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Merve Ersever, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704568
- Sponsor's protocol ID
- E-51381736-771
- Status last verified
- Nov 2024
- First submitted
- 11 Oct 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Kim S, Yi D, Yim J. The Effect of Core Exercise Using Online Videoconferencing Platform and Offline-Based Intervention in Postpartum Woman with Diastasis Recti Abdominis. Int J Environ Res Public Health. 2022 Jun 8;19(12):7031. doi: 10.3390/ijerph19127031.
PubMed 35742279
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory-based Core Exercises in Early Postpartum Improve Abdominal Strength, Pulmonary Function, and Quality of Life
- ClinicalTrials.gov ID
- NCT06704568
- Acronym / sponsor ID
- E-51381736-771
- Conditions
- Postpartum Anxiety, Exercise Overtraining, Fatigue
- Keywords
- core stabilitation, fatigue, pospartum, breathing exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 20 May 2024 (actual)
- Primary completion
- 11 Oct 2024 (actual)
- Study completion
- 11 Oct 2024 (actual)
- First posted
- 26 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 1st group N=30 control group, 2nd group N=30 core exercise group, 3rd group N=30 breathing exercises group will be randomly divided into 3 groups.
| Arm | Type | Receives |
|---|---|---|
| core exercise and early pospartum | Experimental | Other: exerciseUnlike 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 |
| breathing exercise | Experimental | Other: exerciseSlow 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. |
| control | Experimental | Other: exerciseNo application will be made to the control group. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exerciseUnlike 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. | Other | breathing exercise, control, core exercise and early pospartum |
Primary outcome
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
2 secondary outcomes
quality of life test
Time frame: 8 week
Pulmonary Function Test
Time frame: 8 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Background: PubMed 35742279Kim S, Yi D, Yim J. The Effect of Core Exercise Using Online Videoconferencing Platform and Offline-Based Intervention in Postpartum Woman with Diastasis Recti Abdominis. Int J Environ Res Public Health. 2022 Jun 8;19(12):7031. doi: 10.3390/ijerph19127031.
- Individual participant dataSharing planned: Yes
Related trials for Postpartum Anxiety
Active, not recruitingPhase 2/3
Resources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women
Pregnancy Related, Pregnancy Complications
Not yet recruitingObservational study
AI-Enabled Wearable Monitoring for Detection of Postpartum Depression and Anxiety
Postpartum Depression (PPD), Postpartum Anxiety
Active, not recruiting
Improving Maternal Mental Health & SUD Screening and Treatment
Mental Health Issue, Substance Use Disorders
Recruiting
Mother-infant Bonding in the Brain: a Mindfulness-based Intervention
Postpartum Depression, Postpartum Anxiety
Not yet recruiting
Postpartum Care in the NICU Multi-Site
Postpartum, Postpartum Depression (PPD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Postpartum Anxiety and Exercise Overtraining, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static Trunk Endurance Test (time frame: 8 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06704568, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.