Maternal and Fetal Effects of Tele-Rehabilitation-Supported Motor Imagery-Based Exercise in High-Risk Pregnancy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Change in Maternal self well-being
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Motor Imagery Group
Participants will receive an 8-week tele-rehabilitation-supported exercise program consisting of diaphragmatic breathing exercises and motor imagery-based physical activity.
干预措施: Tele-rehabilitation-supported exercise program (Behavioral)
Control Group
Participants will receive a home-based exercise program including diaphragmatic breathing exercises as part of standard care
干预措施: Home exercise program (Behavioral)
结局指标
主要结局
Change in Maternal self well-being
时间窗: 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.
次要结局
- Change in the Umbilical Artery Pulsatility Index(From enrollment to the end of treatment at 8 weeks)
- Change in Umbilical Artery Resistance Index (RI)(From enrollment to the end of treatment at 8 weeks)
- Change in Umbilical Artery The Systolic/Diastolic (S:D) ratio(From enrollment to the end of treatment at 8 weeks)
- Change in Uterine Artery Pulsatility Index(From enrollment to the end of treatment at 8 weeks)
- Change in maternal heart rate(From enrollment to the end of treatment at 8 weeks)
- Change in maternal blood pressure (systolic pressure)(From enrollment to the end of treatment at 8 weeks)
- Change in maternal blood pressure (diastolic pressure)(From enrollment to the end of treatment at 8 weeks)
- Change in oxygen saturation(From enrollment to the end of treatment at 8 weeks)
- Change in the severity of uterine contractions(From enrollment to the end of treatment at 8 weeks)
- Change in Fetal Heart Rate(From enrollment to the end of treatment at 8 weeks)
- Change from baseline in Hospital Anxiety and Depression Scale (HADS) score(From enrollment to the end of treatment at 8 weeks)
研究者
Seda Yakit Yesilyurt
Asst. Prof.
Izmir University of Economics