Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 4:02 AM
Study NCT ID:
NCT07423793
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-20
First Post:
2026-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tele-Supported Motor Imagery Exercise in High-Risk Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a prospective randomized controlled study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-15', 'studyFirstSubmitDate': '2026-02-15', 'studyFirstSubmitQcDate': '2026-02-15', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Maternal self well-being', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': "Well-being will be assessed on a numbered classification scale-11. '0' indicates worse self well-being, '10' indicates excellent self well-being."}], 'secondaryOutcomes': [{'measure': 'Change in the Umbilical Artery Pulsatility Index', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'The Pulsatility Index (PI) is calculated as (peak systolic velocity - end-diastolic velocity) divided by the time-averaged maximum velocity.'}, {'measure': 'Change in Umbilical Artery Resistance Index (RI)', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'The Resistance Index (RI) is calculated as (peak systolic velocity - end-diastolic velocity) divided by peak systolic velocity.'}, {'measure': 'Change in Umbilical Artery The Systolic/Diastolic (S:D) ratio', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'The Systolic/Diastolic (S:D) ratio is calculated as peak systolic velocity divided by end-diastolic velocity.'}, {'measure': 'Change in Uterine Artery Pulsatility Index', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': '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.'}, {'measure': 'Change in maternal heart rate', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'Heart rate measurements will be made with an arm type digital sphygmomanometer.'}, {'measure': 'Change in maternal blood pressure (systolic pressure)', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'Blood pressure measurements will be made with an arm type digital sphygmomanometer.\n\nSystolic blood pressure and diastolic blood pressure will be assessed'}, {'measure': 'Change in maternal blood pressure (diastolic pressure)', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'Blood pressure measurements will be made with an arm type digital sphygmomanometer.\n\nSystolic blood pressure and diastolic blood pressure will be assessed'}, {'measure': 'Change in oxygen saturation', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'Finger type pulse oximeter will be attached and peripheral oxygen saturation will be monitored.'}, {'measure': 'Change in the severity of uterine contractions', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'Uterine contractions severity will be monitored with a cardiotachometer (Philips Avalon Fetal Monitor)'}, {'measure': 'Change in Fetal Heart Rate', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'Fetal heart rate will be monitored with a cardiotachometer.'}, {'measure': 'Change from baseline in Hospital Anxiety and Depression Scale (HADS) score', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['High Risk Pregnancy', 'Tele-rehabilitation', 'Mental Imagery']}, 'descriptionModule': {'briefSummary': '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.\n\nLong-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.\n\nMotor 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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 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:\n\n * 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;\n * Maternal body mass index (BMI) greater than 30 kg/m² leading to physical inactivity.\n2. Ability to read and write in Turkish.\n3. Willingness to participate voluntarily in the study.\n\nExclusion Criteria:\n\n1. Pregnant women with conditions such as gestational diabetes mellitus or pregnancy-induced hypertension for whom physical activity is recommended.\n2. Presence of severe cardiovascular, pulmonary, or systemic disorders.\n3. Presence of seizure disorders or significant psychiatric conditions.\n4. Any cognitive impairment that interferes with cooperation or understanding.\n5. Any medical condition that prevents safe and effective implementation of the interventions.\n6. Other high-risk obstetric conditions requiring early medical intervention (e.g., premature rupture of membranes, placenta previa, preeclampsia).\n\nLack of digital literacy required to participate in tele-rehabilitation.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07423793', 'briefTitle': 'Tele-Supported Motor Imagery Exercise in High-Risk Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Izmir University of Economics'}, 'officialTitle': 'Maternal and Fetal Effects of Tele-Rehabilitation-Supported Motor Imagery-Based Exercise in High-Risk Pregnancy: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'İEU_SYY_6'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Motor Imagery Group', 'description': 'Participants will receive an 8-week tele-rehabilitation-supported exercise program consisting of diaphragmatic breathing exercises and motor imagery-based physical activity.', 'interventionNames': ['Behavioral: Tele-rehabilitation-supported exercise program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Participants will receive a home-based exercise program including diaphragmatic breathing exercises as part of standard care', 'interventionNames': ['Behavioral: Home exercise program']}], 'interventions': [{'name': 'Tele-rehabilitation-supported exercise program', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Motor Imagery Group']}, {'name': 'Home exercise program', 'type': 'BEHAVIORAL', 'description': '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.\n\nParticipants in the control group will be instructed to perform the taught diaphragmatic breathing exercises at home once per week.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Adnan Budak', 'role': 'CONTACT', 'email': 'budakadnan@hotmail.com', 'phone': '+902324696969'}], 'facility': 'Health Sciences University İzmir Tepecik Education And Research Hospital', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'centralContacts': [{'name': 'Seda Yakıt Yeşilyurt', 'role': 'CONTACT', 'email': 'sedayakit01@gmail.com', 'phone': '00902322792525'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Izmir University of Economics', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asst. Prof.', 'investigatorFullName': 'Seda Yakit Yesilyurt', 'investigatorAffiliation': 'Izmir University of Economics'}}}}