High Risk PregnancyNCT07423793
Tele-Supported Motor Imagery Exercise in High-Risk Pregnancy
A study testing Tele-rehabilitation-supported exercise program and Home exercise program in people with High Risk Pregnancy and Tele-rehabilitation, run by Izmir University of Economics at 1 site in Turkey (Türkiye).
Trial summary
High-risk pregnancy is defined as a pregnancy in which there is an increased likelihood of adverse maternal and/or fetal outcomes due to maternal or fetal conditions. The global prevalence of high-risk pregnancies ranges between 10% and 60%. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- High Risk Pregnancy, Tele-rehabilitation, Mental Imagery
- What is being tested?
- Tele-rehabilitation-supported exercise program and Home exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2026to 28 Feb 2027
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women who have completed the 12th week of gestation, are hospitalized for inpatient care, and have at least one of the following risk factors:
- Obstetric conditions associated with adverse outcomes and physical activity restriction, such as cervical insufficiency, multiple pregnancy, or uncontrolled gestational diabetes, for which exercise is contraindicated;
- Maternal body mass index (BMI) greater than 30 kg/m² leading to physical inactivity.
- Ability to read and write in Turkish.
- Willingness to participate voluntarily in the study.
Who cannot join
- Pregnant women with conditions such as gestational diabetes mellitus or pregnancy-induced hypertension for whom physical activity is recommended.
- Presence of severe cardiovascular, pulmonary, or systemic disorders.
- Presence of seizure disorders or significant psychiatric conditions.
- Any cognitive impairment that interferes with cooperation or understanding.
- Any medical condition that prevents safe and effective implementation of the interventions.
- Other high-risk obstetric conditions requiring early medical intervention (e.g., premature rupture of membranes, placenta previa, preeclampsia).
- Lack of digital literacy required to participate in tele-rehabilitation.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Health Sciences University İzmir Tepecik Education And Research Hospital
Izmir
Adnan Budak, +902324696969, budakadnan@hotmail.com
About this study
Official title: Maternal and Fetal Effects of Tele-Rehabilitation-Supported Motor Imagery-Based Exercise in High-Risk Pregnancy: A Randomized Controlled Trial
High-risk pregnancy is defined as a pregnancy in which there is an increased likelihood of adverse maternal and/or fetal outcomes due to maternal or fetal conditions. The global prevalence of high-risk pregnancies ranges between 10% and 60%. In cases where pregnancy complications occur, bed rest is frequently recommended to prevent further deterioration. However, prolonged inactivity may lead to unfavorable maternal outcomes, and appropriately prescribed exercise may help reduce the negative consequences of immobility.
Long-term maternal exercise has been shown to promote vascular remodeling and angiogenesis in the uterine and umbilical arteries, increase vessel diameter, and reduce vascular resistance. Previous studies have demonstrated that exercise reduces the risk of gestational diabetes, preeclampsia, gestational hypertension, and macrosomia without increasing the risk of preterm birth, low birth weight, or perinatal mortality. Despite these benefits, women with high-risk pregnancies may have different perceptions and concerns regarding physical activity compared to healthy pregnant women.
Read more
Motor imagery is a mental process in which an individual cognitively rehearses a movement without performing it physically. Neuroimaging studies have demonstrated activation of similar brain regions during motor imagery and actual movement. Mental imagery-guided relaxation exercises have been shown to improve maternal anxiety, stress levels, fetal attachment, and blood pressure in both healthy and hypertensive pregnancies. Recent findings also indicate that motor imagery-based exercise combined with diaphragmatic breathing does not adversely affect the fetus in high-risk pregnancies and may improve maternal well-being and oxygen saturation without inducing uterine contractions.
This randomized controlled trial aims to investigate the maternal and fetal effects of an 8-week tele-rehabilitation-supported motor imagery-based exercise program in high-risk pregnant women who are prescribed hospital- or home-based bed rest.
- Conditions
- High Risk Pregnancy, Tele-rehabilitation, Mental Imagery
- Being tested
- Tele-rehabilitation-supported exercise program, Home exercise program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-rehabilitation-supported exercise programBehavioural
Diaphragmatic breathing will be shown to pregnant women in the supine position, eyes closed, with one hand on the chest and the other hand on the abdomen. This practice will last for five minutes. Then motor imagery will be performed according to the PETTLEP (Physical, Environment, Task, Time, Learn, Emotion, Perspective) model for 15 minutes. 1) To imagine walking activity in different environments (seaside, beach, walking path). 2) The rest activity will be imagined by sitting on a bench. 3) Upper extremity strengthening exercises with dumbbells, lower extremity strengthening exercises with elastic band and trunk-oriented bridging, posterior pelvic tilt and table top stabilization exercises will be visualized. 4) The rest activity will be imagined by sitting on a bench. 5) Imagination will end with homecoming and domestic activities.
Home exercise programBehavioural
Diaphragmatic breathing will be demonstrated to pregnant women in the supine position, with eyes closed, placing one hand on the chest and the other on the abdomen. The breathing practice will be performed for five minutes.
Participants in the control group will be instructed to perform the taught diaphragmatic breathing exercises at home once per week.
| Study group | Role | What they receive |
|---|---|---|
| Motor Imagery Group | Experimental | Participants will receive an 8-week tele-rehabilitation-supported exercise program consisting of diaphragmatic breathing exercises and motor imagery-based physical activity. Receives: Behavioral: Tele-rehabilitation-supported exercise program |
| Control Group | Active comparator | Participants will receive a home-based exercise program including diaphragmatic breathing exercises as part of standard care Receives: Behavioral: Home exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maternal self well-being
Well-being will be assessed on a numbered classification scale-11. '0' indicates worse self well-being, '10' indicates excellent self well-being.
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (11)
Change in the Umbilical Artery Pulsatility Index
The Pulsatility Index (PI) is calculated as (peak systolic velocity - end-diastolic velocity) divided by the time-averaged maximum velocity.
Measured: From enrollment to the end of treatment at 8 weeks
Change in Umbilical Artery Resistance Index (RI)
The Resistance Index (RI) is calculated as (peak systolic velocity - end-diastolic velocity) divided by peak systolic velocity.
Measured: From enrollment to the end of treatment at 8 weeks
Change in Umbilical Artery The Systolic/Diastolic (S:D) ratio
The Systolic/Diastolic (S:D) ratio is calculated as peak systolic velocity divided by end-diastolic velocity.
Measured: From enrollment to the end of treatment at 8 weeks
Change in Uterine Artery Pulsatility Index
Uterine artery Doppler velocimetry will be performed immediately cranial to the point of vessel crossover. Three consecutive uniform waveforms will be obtained to calculate the Pulsatility Index (PI) and to evaluate the presence or absence of an early diastolic notch.
Measured: From enrollment to the end of treatment at 8 weeks
Change in maternal heart rate
Heart rate measurements will be made with an arm type digital sphygmomanometer.
Measured: From enrollment to the end of treatment at 8 weeks
Change in maternal blood pressure (systolic pressure)
Blood pressure measurements will be made with an arm type digital sphygmomanometer.
Systolic blood pressure and diastolic blood pressure will be assessed
Measured: From enrollment to the end of treatment at 8 weeks
Change in maternal blood pressure (diastolic pressure)
Blood pressure measurements will be made with an arm type digital sphygmomanometer.
Systolic blood pressure and diastolic blood pressure will be assessed
Measured: From enrollment to the end of treatment at 8 weeks
Change in oxygen saturation
Finger type pulse oximeter will be attached and peripheral oxygen saturation will be monitored.
Measured: From enrollment to the end of treatment at 8 weeks
Change in the severity of uterine contractions
Uterine contractions severity will be monitored with a cardiotachometer (Philips Avalon Fetal Monitor)
Measured: From enrollment to the end of treatment at 8 weeks
Change in Fetal Heart Rate
Fetal heart rate will be monitored with a cardiotachometer.
Measured: From enrollment to the end of treatment at 8 weeks
Change from baseline in Hospital Anxiety and Depression Scale (HADS) score
The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-report questionnaire used to assess anxiety and depression levels in individuals with physical health conditions. In this study, pregnancy-related anxiety and depression levels will be evaluated using HADS. Each item is rated on a 4-point Likert scale ranging from 0 (absence) to 3 (maximum severity). The total score ranges from 0 to 42, with a maximum of 21 points for each subscale (anxiety and depression). Higher scores indicate greater levels of anxiety or depression.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start20 Feb 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk PregnancyStudies 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
- Parallel groups
- Model description
- This is a prospective randomized controlled study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir University of Economics
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Yakit Yesilyurt, Izmir University of Economics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423793
- Sponsor's protocol ID
- İEU_SYY_6
- Status last verified
- Feb 2026
- First submitted
- 15 Feb 2026
- Last updated
- 2 Sep 2026
- 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 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal and Fetal Effects of Tele-Rehabilitation-Supported Motor Imagery-Based Exercise in High-Risk Pregnancy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07423793
- Acronym / sponsor ID
- İEU_SYY_6
- Conditions
- High Risk Pregnancy, Tele-rehabilitation, Mental Imagery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Izmir University of EconomicsUniversity, hospital or other
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 20 Feb 2026 (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.
High-risk pregnancy is defined as a pregnancy in which there is an increased likelihood of adverse maternal and/or fetal outcomes due to maternal or fetal conditions. The global prevalence of high-risk pregnancies ranges between 10% and 60%. In cases where pregnancy complications occur, bed rest is frequently recommended to prevent further deterioration. However, prolonged inactivity may lead to unfavorable maternal outcomes, and appropriately prescribed exercise may help reduce the negative consequences of immobility.
Long-term maternal exercise has been shown to promote vascular remodeling and angiogenesis in the uterine and umbilical arteries, increase vessel diameter, and reduce vascular resistance. Previous studies have demonstrated that exercise reduces the risk of gestational diabetes, preeclampsia, gestational hypertension, and macrosomia without increasing the risk of preterm birth, low birth weight, or perinatal mortality. Despite these benefits, women with high-risk pregnancies may have different perceptions and concerns regarding physical activity compared to healthy pregnant women.
Motor imagery is a mental process in which an individual cognitively rehearses a movement without performing it physically. Neuroimaging studies have demonstrated activation of similar brain regions during motor imagery and actual movement. Mental imagery-guided relaxation exercises have been shown to improve maternal anxiety, stress levels, fetal attachment, and blood pressure in both healthy and hypertensive pregnancies. Recent findings also indicate that motor imagery-based exercise combined with diaphragmatic breathing does not adversely affect the fetus in high-risk pregnancies and may improve maternal well-being and oxygen saturation without inducing uterine contractions.
This randomized controlled trial aims to investigate the maternal and fetal effects of an 8-week tele-rehabilitation-supported motor imagery-based exercise program in high-risk pregnant women who are prescribed hospital- or home-based bed rest.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective randomized controlled study.
| Arm | Type | Receives |
|---|---|---|
| Motor Imagery Group | Experimental | Behavioral: Tele-rehabilitation-supported exercise programParticipants will receive an 8-week tele-rehabilitation-supported exercise program consisting of diaphragmatic breathing exercises and motor imagery-based physical activity. |
| Control Group | Active comparator | Behavioral: Home exercise programParticipants will receive a home-based exercise program including diaphragmatic breathing exercises as part of standard care |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pregnant women who have completed the 12th week of gestation, are hospitalized for inpatient care, and have at least one of the following risk factors:
- Ability to read and write in Turkish.
- Willingness to participate voluntarily in the study.
Key exclusion criteria (8 listed)
- Pregnant women with conditions such as gestational diabetes mellitus or pregnancy-induced hypertension for whom physical activity is recommended.
- Presence of severe cardiovascular, pulmonary, or systemic disorders.
- Presence of seizure disorders or significant psychiatric conditions.
- Any cognitive impairment that interferes with cooperation or understanding.
- Any medical condition that prevents safe and effective implementation of the interventions.
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 |
|---|---|---|
| Tele-rehabilitation-supported exercise programDiaphragmatic breathing will be shown to pregnant women in the supine position, eyes closed, with one hand on the chest and the other hand on the abdomen. This practice will last for five minutes. Then motor imagery will be performed according to the PETTLEP (Physical, Environment, Task, Time, Learn, Emotion, Perspective) model for 15 minutes. 1) To imagine walking activity in different environments (seaside, beach, walking path). 2) The rest activity will be imagined by sitting on a bench. 3) Upper extremity strengthening exercises with dumbbells, lower extremity strengthening exercises with elastic band and trunk-oriented bridging, posterior pelvic tilt and table top stabilization exercises will be visualized. 4) The rest activity will be imagined by sitting on a bench. 5) Imagination will end with homecoming and domestic activities. | Behavioural | Motor Imagery Group |
| Home exercise programDiaphragmatic breathing will be demonstrated to pregnant women in the supine position, with eyes closed, placing one hand on the chest and the other on the abdomen. The breathing practice will be performed for five minutes. Participants in the control group will be instructed to perform the taught diaphragmatic breathing exercises at home once per week. | Behavioural | Control Group |
Primary outcome
Change in Maternal self well-being
Time frame: From enrollment to the end of treatment at 8 weeks
Well-being will be assessed on a numbered classification scale-11. '0' indicates worse self well-being, '10' indicates excellent self well-being.
11 secondary outcomes
Change in the Umbilical Artery Pulsatility Index
Time frame: From enrollment to the end of treatment at 8 weeks
Change in Umbilical Artery Resistance Index (RI)
Time frame: From enrollment to the end of treatment at 8 weeks
Change in Umbilical Artery The Systolic/Diastolic (S:D) ratio
Time frame: From enrollment to the end of treatment at 8 weeks
Change in Uterine Artery Pulsatility Index
Time frame: From enrollment to the end of treatment at 8 weeks
Change in maternal heart rate
Time frame: From enrollment to the end of treatment at 8 weeks
Change in maternal blood pressure (systolic pressure)
Time frame: From enrollment to the end of treatment at 8 weeks
Change in maternal blood pressure (diastolic pressure)
Time frame: From enrollment to the end of treatment at 8 weeks
Change in oxygen saturation
Time frame: From enrollment to the end of treatment at 8 weeks
Change in the severity of uterine contractions
Time frame: From enrollment to the end of treatment at 8 weeks
Change in Fetal Heart Rate
Time frame: From enrollment to the end of treatment at 8 weeks
Change from baseline in Hospital Anxiety and Depression Scale (HADS) score
Time frame: From enrollment to the end of treatment at 8 weeks
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 2 Sep 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-rehabilitation-supported exercise program and Home exercise program in people with High Risk Pregnancy and Tele-rehabilitation, run by Izmir University of Economics 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 8 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: looking for participants now, as of the sponsor's last update on 2 Sep 2026. 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?
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 Seda Yakıt Yeşilyurt (00902322792525, sedayakit01@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Maternal self well-being (time frame: From enrollment to the end of treatment at 8 weeks). 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 2 Sep 2026.