Tele-Supported Motor Imagery Exercise in High-Risk Pregnancy

Официальное название

Maternal and Fetal Effects of Tele-Rehabilitation-Supported Motor Imagery-Based Exercise in High-Risk Pregnancy: A Randomized Controlled Trial

Обзор

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.

Вмешательства

• Поведенческое Tele-rehabilitation-supported exercise program
  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) U
• Поведенческое Home exercise program
  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.

Первичные конечные точки

• Change in Maternal self well-being [Срок оценки: From enrollment to the end of treatment at 8 weeks]

Вторичные конечные точки (11)

• Change in the Umbilical Artery Pulsatility Index [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Change in Umbilical Artery Resistance Index (RI) [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Change in Umbilical Artery The Systolic/Diastolic (S:D) ratio [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Change in Uterine Artery Pulsatility Index [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Change in maternal heart rate [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Change in maternal blood pressure (systolic pressure) [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Change in maternal blood pressure (diastolic pressure) [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Change in oxygen saturation [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Change in the severity of uterine contractions [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Change in Fetal Heart Rate [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Change from baseline in Hospital Anxiety and Depression Scale (HADS) score [Срок оценки: From enrollment to the end of treatment at 8 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Health Sciences University İzmir Tepecik Education And Research Hospital — Izmir

Идентификаторы

NCT: NCT07423793 · İEU_SYY_6

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗