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NCT Number: NCT07423793

Tele-Supported Motor Imagery Exercise in High-Risk Pregnancy

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.

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Key information

Conditions

High Risk Pregnancy Mental Imagery Tele-rehabilitation

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Health Sciences University İzmir Tepecik Education And Research Hospital

Izmir, Turkey (Türkiye)

Location contact

Adnan Budak

CONTACT

[email protected]

+902324696969

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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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Treatment and study plan

Tele-rehabilitation-supported exercise program

Behavioral

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 Program

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in the Umbilical Artery Pulsatility Index

    Time frame: From enrollment to the end of treatment at 8 weeks

    The Pulsatility Index (PI) is calculated as (peak systolic velocity - end-diastolic velocity) divided by the time-averaged maximum velocity.

  2. Change in Umbilical Artery Resistance Index (RI)

    Time frame: From enrollment to the end of treatment at 8 weeks

    The Resistance Index (RI) is calculated as (peak systolic velocity - end-diastolic velocity) divided by peak systolic velocity.

  3. Change in Umbilical Artery The Systolic/Diastolic (S:D) ratio

    Time frame: From enrollment to the end of treatment at 8 weeks

    The Systolic/Diastolic (S:D) ratio is calculated as peak systolic velocity divided by end-diastolic velocity.

  4. Change in Uterine Artery Pulsatility Index

    Time frame: From enrollment to the end of treatment at 8 weeks

    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.

  5. Change in maternal heart rate

    Time frame: From enrollment to the end of treatment at 8 weeks

    Heart rate measurements will be made with an arm type digital sphygmomanometer.

  6. Change in maternal blood pressure (systolic pressure)

    Time frame: From enrollment to the end of treatment at 8 weeks

    Blood pressure measurements will be made with an arm type digital sphygmomanometer.

    Systolic blood pressure and diastolic blood pressure will be assessed

  7. Change in maternal blood pressure (diastolic pressure)

    Time frame: From enrollment to the end of treatment at 8 weeks

    Blood pressure measurements will be made with an arm type digital sphygmomanometer.

    Systolic blood pressure and diastolic blood pressure will be assessed

  8. Change in oxygen saturation

    Time frame: From enrollment to the end of treatment at 8 weeks

    Finger type pulse oximeter will be attached and peripheral oxygen saturation will be monitored.

  9. Change in the severity of uterine contractions

    Time frame: From enrollment to the end of treatment at 8 weeks

    Uterine contractions severity will be monitored with a cardiotachometer (Philips Avalon Fetal Monitor)

  10. Change in Fetal Heart Rate

    Time frame: From enrollment to the end of treatment at 8 weeks

    Fetal heart rate will be monitored with a cardiotachometer.

  11. Change from baseline in Hospital Anxiety and Depression Scale (HADS) score

    Time frame: From enrollment to the end of treatment at 8 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Seda Yakıt Yeşilyurt

CONTACT

[email protected]

00902322792525

Sponsors and collaborators

Lead sponsor

Izmir University of Economics

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 20, 2026
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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