PostpartumNCT06990009
The Effect of Physical Exercise After Childbirth
A study testing exercise in people with Postpartum, run by ümran erciyes.
Trial summary
Postpartum women are recommended to engage in physical activity including moderate intensity aerobic and strengthening exercises for at least 150 minutes within one week. The benefits of postpartum exercise include strengthening abdominal muscles, increasing energy, preventing postpartum depression, reducing stress… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum
- What is being tested?
- exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2025to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be over 18 years of age
- Be able to read and write in Turkish
- Be in the 24th postpartum hour
- Have had a vaginal delivery
- Have had a single live birth -Have had a single live birth
- Be primiparous
Show all 11Show fewer
- Have given birth at term -Have given birth at term
- Accept to participate in the study
- Have no musculoskeletal disorder preventing exercise
- Have no chronic disorder preventing exercise
- Using a smart phone
Who cannot join
- Having a regular exercise program
- Having a baby in intensive care
- Having a psychiatric treatment in the postpartum period
- Being multiparous
- Willing to voluntarily leave the study
- Did not perform the exercises more than two days in a week
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Physical Exercise on Sleep Quality, Quality of Life and Fatigue in Postpartum Women
Postpartum women are recommended to engage in physical activity including moderate intensity aerobic and strengthening exercises for at least 150 minutes within one week. The benefits of postpartum exercise include strengthening abdominal muscles, increasing energy, preventing postpartum depression, reducing stress, improving sleep quality and losing excess weight gained during pregnancy. However, activity levels of women who have given birth are reported to be very low, despite the great benefits of exercise on physical and mental health. In a meta-analysis, it was stated that exercise can be used for counseling and therapeutic purposes to improve postpartum quality of life and reduce fatigue.
Read the detailed description
Although studies evaluating sleep quality, quality of life and fatigue of postpartum women have been found in the literature, no study evaluating the effect of postpartum physical exercise in Turkey has been found yet. Accordingly, this study was planned to evaluate the effect of physical exercise on sleep quality, quality of life and fatigue in postpartum women.
- Conditions
- Postpartum
- Being tested
- exercise
- Keywords
- exercise, quality of life, fatigue, sleep, postpartum
- Medical subject headings
- Motor Activity, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseBehavioural
In line with the Puerperium and Newborn Care Guide, an exercise implementation protocol will be prepared by obtaining the opinion of a group of 10 experts on the appropriateness of the exercises and when they should be started. In this direction, a brochure and a video will be created for the participants to practice the exercises. A pilot study will be conducted in a group of 10 people on the use of the brochure and video, and the brochure and video will be finalized. Participants will be asked to do these exercises for 30 minutes a day, five days a week for eight weeks. A reminder message will be sent to the exercise group by the researchers to remind them of the exercises and provide motivation for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| exercise | Experimental | In line with the Puerperium and Newborn Care Guide, an exercise implementation protocol will be prepared by obtaining the opinion of a group of 10 experts on the appropriateness of the exercises and when they should be started. In this direction, a brochure and a video will be created for the participants to practice the exercises. A pilot study will be conducted in a group of 10 people on the use of the brochure and video, and the brochure and video will be finalized.
Participants will be asked to do these exercises for 30 minutes a day, five days a week for eight weeks. A reminder message will be sent to the exercise group by the researchers to remind them of the exercises and provide motivation for eight weeks. Receives: Behavioral: exercise |
| control | No intervention | The control group will not receive any intervention and routine care will continue. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical exercise increases sleep quality in postpartum women
Physical exercise improves sleep quality in postpartum women. Participants will be asked to do these exercises for 30 minutes a day, five days a week and for eight weeks in accordance with the brochure and video prepared for the exercise. An evaluation will be made with Pittsburg Sleep Quality Index at the 24th hour and in the fourth week after birth. The final evaluation will be made at the end of the eighth week.
Pittsburg Sleep Quality Index was developed by Buysse et al. in 1989. Turkish validity and reliability study was conducted by Ağargün et al. in 1996. It consists of a total of 24 questions, 19 of which are answered by the individual and five of which are answered by the relative/roommate. The 19 questions answered by the individual are included in the scoring. It consists of seven components that assess sleep duration, subjective sleep quality, sleep efficiency, sleep latency, the degree to which sleep interferes with daytime activities and the use of sleeping pills.
Measured: 8 week
Physical exercise increases the quality of life in postpartum women
The WHOQOL-BREF-TR will be evaluated at 24 hours and 4 weeks after delivery. The final evaluation will be made at the end of the 8th week. The effect of exercise on quality of life will be evaluated.
WHOQOL-BREF-TR is a scale developed by the World Health Organization's Quality of Life Group to assess how people perceive their quality of life. The Turkish validity and reliability study of the questionnaire was conducted by Eser and colleagues in 1999. It is a shortened version of the 100-question quality of life scale reduced to 26 questions. The 27th question is a national question. While answering the questions, people are asked to think about the last 15 days of their lives. It is a five-point Likert-type scale. Scores are calculated in four domains and the first two questions are general health assessments and are not used to calculate quality of life.
Measured: 8 week
Physical exercise reduces fatigue in postpartum women
Participants will be asked to do the exercises for 30 minutes a day, five days a week, and for eight weeks. The Piper Fatigue Scale will be used to evaluate the 24th hour and fourth week after birth. The final evaluation will be made at the end of the eighth week. The effect of exercise on reducing fatigue will be evaluated.
Piper Fatigue Scale: In 1998, it was developed by F. Piper and colleagues. Turkish validity and reliability study was conducted by Can et al. in 2001. It consists of 22 items and four sub-dimensions. When calculating the score, each item is scored between 0-10 and the total score is divided by the number of items. To calculate the subscale scores, the items in each subscale are summed and divided by the number of items in the relevant subscale. A high score on the scale indicates a high level of fatigue. While the total cronbach alpha coefficient of the scale is 0.94, the value of the subscales varies between 0.87-0.91.
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 posted25 May 2025
- Study start15 Aug 2025 (estimated)
- Primary completion15 Aug 2025 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostpartumStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ümran erciyes
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Sponsor-investigator, ümran erciyes, Istanbul University - Cerrahpasa
- Investigators
- Tülay YILMAZ, Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990009
- Sponsor's protocol ID
- 2025/183
- Status last verified
- Apr 2025
- First submitted
- 12 Apr 2025
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Physical Exercise on Sleep Quality, Quality of Life and Fatigue in Postpartum Women
- ClinicalTrials.gov ID
- NCT06990009
- Acronym / sponsor ID
- 2025/183
- Conditions
- Postpartum
- Keywords
- exercise, quality of life, fatigue, sleep, postpartum
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- ümran erciyesUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 15 Aug 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 25 May 2025 (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.
Postpartum women are recommended to engage in physical activity including moderate intensity aerobic and strengthening exercises for at least 150 minutes within one week. The benefits of postpartum exercise include strengthening abdominal muscles, increasing energy, preventing postpartum depression, reducing stress, improving sleep quality and losing excess weight gained during pregnancy. However, activity levels of women who have given birth are reported to be very low, despite the great benefits of exercise on physical and mental health. In a meta-analysis, it was stated that exercise can be used for counseling and therapeutic purposes to improve postpartum quality of life and reduce fatigue.
Detailed description
Although studies evaluating sleep quality, quality of life and fatigue of postpartum women have been found in the literature, no study evaluating the effect of postpartum physical exercise in Turkey has been found yet. Accordingly, this study was planned to evaluate the effect of physical exercise on sleep quality, quality of life and fatigue in postpartum women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- a randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| exercise | Experimental | Behavioral: exerciseIn line with the Puerperium and Newborn Care Guide, an exercise implementation protocol will be prepared by obtaining the opinion of a group of 10 experts on the appropriateness of the exercises and when they should be started. In this direction, a brochure and a video will be created for the participants to practice the exercises. A pilot study will be conducted in a group of 10 people on the use of the brochure and video, and the brochure and video will be finalized. Participants will be asked to do these exercises for 30 minutes a day, five days a week for eight weeks. A reminder message will be sent to the exercise group by the researchers to remind them of the exercises and provide motivation for eight weeks. |
| control | No intervention | –The control group will not receive any intervention and routine care will continue. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Be over 18 years of age
- Be able to read and write in Turkish
- Be in the 24th postpartum hour
- Have had a vaginal delivery
- Have had a single live birth -Have had a single live birth
Key exclusion criteria (6 listed)
- Having a regular exercise program
- Having a baby in intensive care
- Having a psychiatric treatment in the postpartum period
- Being multiparous
- Willing to voluntarily leave the study
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 |
|---|---|---|
| exerciseIn line with the Puerperium and Newborn Care Guide, an exercise implementation protocol will be prepared by obtaining the opinion of a group of 10 experts on the appropriateness of the exercises and when they should be started. In this direction, a brochure and a video will be created for the participants to practice the exercises. A pilot study will be conducted in a group of 10 people on the use of the brochure and video, and the brochure and video will be finalized. Participants will be asked to do these exercises for 30 minutes a day, five days a week for eight weeks. A reminder message will be sent to the exercise group by the researchers to remind them of the exercises and provide motivation for eight weeks. | Behavioural | exercise |
Primary outcome
Physical exercise increases sleep quality in postpartum women
Time frame: 8 week
Physical exercise improves sleep quality in postpartum women. Participants will be asked to do these exercises for 30 minutes a day, five days a week and for eight weeks in accordance with the brochure and video prepared for the exercise. An evaluation will be made with Pittsburg Sleep Quality Index at the 24th hour and in the fourth week after birth. The final evaluation will be made at the end of the eighth week. Pittsburg Sleep Quality Index was developed by Buysse et al. in 1989. Turkish validity and reliability study was conducted by Ağargün et al. in 1996. It consists of a total of 24 questions, 19 of which are answered by the individual and five of which are answered by the relative/roommate. The 19 questions answered by the individual are included in the scoring. It consists of seven components that assess sleep duration, subjective sleep quality, sleep efficiency, sleep latency, the degree to which sleep interferes with daytime activities and the use of sleeping pills.
Physical exercise increases the quality of life in postpartum women
Time frame: 8 week
The WHOQOL-BREF-TR will be evaluated at 24 hours and 4 weeks after delivery. The final evaluation will be made at the end of the 8th week. The effect of exercise on quality of life will be evaluated. WHOQOL-BREF-TR is a scale developed by the World Health Organization's Quality of Life Group to assess how people perceive their quality of life. The Turkish validity and reliability study of the questionnaire was conducted by Eser and colleagues in 1999. It is a shortened version of the 100-question quality of life scale reduced to 26 questions. The 27th question is a national question. While answering the questions, people are asked to think about the last 15 days of their lives. It is a five-point Likert-type scale. Scores are calculated in four domains and the first two questions are general health assessments and are not used to calculate quality of life.
Physical exercise reduces fatigue in postpartum women
Time frame: 8 week
Participants will be asked to do the exercises for 30 minutes a day, five days a week, and for eight weeks. The Piper Fatigue Scale will be used to evaluate the 24th hour and fourth week after birth. The final evaluation will be made at the end of the eighth week. The effect of exercise on reducing fatigue will be evaluated. Piper Fatigue Scale: In 1998, it was developed by F. Piper and colleagues. Turkish validity and reliability study was conducted by Can et al. in 2001. It consists of 22 items and four sub-dimensions. When calculating the score, each item is scored between 0-10 and the total score is divided by the number of items. To calculate the subscale scores, the items in each subscale are summed and divided by the number of items in the relevant subscale. A high score on the scale indicates a high level of fatigue. While the total cronbach alpha coefficient of the scale is 0.94, the value of the subscales varies between 0.87-0.91.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Postpartum
Active, not recruiting
Hypopressive-Core Stabilization With and Without Whole-Body Vibration in Postpartum Pelvic Girdle Pain
Postpartum Pelvic Girdle Pain
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
Recruiting
Restoring Emotional Needs With Exogenous Ketones for Women With Postpartum Depression
Postpartum Depression (PPD)
Recruiting
Trauma-informed Approach to Timely Detection and Management of Early Postpartum Hypertension
Postpartum Hypertension
RecruitingEarly Phase 1
Evaluating Pain Control Strategies in Postpartum Patients on Opioid Use Disorder Medications.
Substance Use Disorder (SUD)
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.
Tülay YILMAZ study director
Istanbul University - Cerrahpasa
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Postpartum, run by ümran erciyes.
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 11 inclusion and 6 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: opening soon, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ümran ERCİYES (+905432070138, umranerciyes@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical exercise increases sleep quality in postpartum women (time frame: 8 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2025.