NCT07423793

Brief 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%. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress31%
Feb 2026Feb 2027

First Submitted

Initial submission to the registry

February 15, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 20, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

February 20, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

9 months

First QC Date

February 15, 2026

Last Update Submit

February 15, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (11)

  • 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

  • +6 more secondary outcomes

Study Arms (2)

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.

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

Behavioral: Home exercise program

Interventions

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.

Motor Imagery Group

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.

Control Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Sciences University İzmir Tepecik Education And Research Hospital

Izmir, Turkey (Türkiye)

Location

Central Study Contacts

Seda Yakıt Yeşilyurt

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a prospective randomized controlled study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

February 15, 2026

First Posted

February 20, 2026

Study Start

February 20, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

February 28, 2027

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations