Remotely Monitored Exercise Program in Pregnant Women With Obesity

Not Applicable

• Conditions: Pregnancy Related; Obesity, Maternal
• Interventions: Behavioral: Remote Exercise

• Registration Number: NCT05331586
• Lead Sponsor: Universidade do Porto

Brief Summary

Pregnant women with obesity will be invited to participate in structured home-based exercise programme, remotely monitored

Detailed Description

Pregnant women with obesity will be invited to participate in structured home-based exercise programme, remotely monitored. The remote system use inertial motion trackers, digitizes pregnant women motion and provides real-time feedback on performance through a mobile app. It also includes a web-based platform that allows the clinical team to prescribe, monitor and adapt the exercise program remotely. This way, the system allows patients to perform independent exercise program at home without the need for constant therapist supervision, ensuring remote monitoring throughout the rehabilitation program. The exercise programme will be performed since the first gestational trimester until delivery.

Data of gestational weight gain, gestational diabetes mellitus, low back pain and quality of life will be colected.

Study Timeline

• Status Verified: 2022-02
• Study First Submitted: 2022-03-03
• Study First Submitted QC: 2022-04-11
• Study First Posted: 2022-04-15
• Last Update Submitted: 2022-06-20
• Last Update Posted: 2022-06-22
• Study Start: 2022-07
• Primary Completion: 2022-12
• Study Completion: 2023-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Pregnant women with obesity (BMI ≥ 30 kg/m2) at first gestational trimester

Exclusion Criteria

• pre-pregnancy BMI < 30 kg/m2;
• previous bariatric surgery;
• hemodynamically significant heart disease;
• restrictive lung disease;
• incompetent cervix or cerclage;
• multiple gestation;
• persistent second- or third-trimester bleeding;
• placenta previa after 26 weeks of gestation;
• premature labor during the current pregnancy;
• ruptured membranes;
• preeclampsia or pregnancy-induced hypertension;
• severe anemia;
• inability to read and understand Portuguese; ->15 weeks gestation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise intervention	Remote Exercise	The exercise group intervention will perform home-based remotely monitored exercise

Primary Outcome Measures

Name	Time	Method
Excessive gestational weight gain	At delivery	The adequate gestational weight gain in pregnant women with obesity should not exceed 9kg in entire pregnancy, the values over these thresholds will be considered excessive gestational weight gain.
Gestational Weight Gain	At delivery	Using portable digital scale (Tantita InnerScan BC-545). Gestational weight gain will be calculated as the difference between maternal weight at last appointment (36-39 gestational weeks) and pre-pregnancy weight.

Secondary Outcome Measures

Name	Time	Method
Quality of Life Assessment	At first, second and third gestational trimester	COOP-Quality of life during Pregnancy Questionnaire
Subjective Physical Activity assessment	At first, second and third gestational trimester	Pregnancy Physical Activity Questionnaire (PPAQ) is a self-reported questionnaire. The objective is measure the type and intensity of pregnant women physical activity.
Pelvic Floor and sexual disorders during pregnancy	At first, second and third gestational trimester	Assessment of Pelvic Floor Disorders and Their Risk Factors During Pregnancy and Postpartum Questionnaire
Low Back Pain	At first, second and third gestational trimester	Oswestry Low Back Pain Disability Questionnaire (ODI v2.0)
Objective Physical Activity assessment	At first, second and third gestational trimester	Accelerometry, is a device that monitors the acceleration of body segments, it is considered the gold standard with regard to objectivity and reliability (ICC:0.661-0.806)
Gestational Diabetes Mellitus	Second gestational trimester	The presence of gestational diabetes mellitus will be assessed between 24-28 gestation weeks, through the Oral Glucose Tolerance Test. Blood sampling for fasting glucose concentrations will be taken after a 10 hour overnight fast, and glucose tolerance will measured by a 2 hours 75 mg per-oral glucose tolerance test. GDM will be diagnosed as fasting glucose ≥ 126 mg/dl or 2h concentration ≥ 200 mg/dl.

Trial Locations

Locations (1)

Diana Bernardo; 🇵🇹 Porto, Portugal