Remotely Monitored Exercise Program in Pregnant Women With Obesity

Universidade do Porto40 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Pregnancy Related Obesity, Maternal

Interventions

Remote ExerciseBEHAVIORAL

The pregnant women will perform a home-based structured exercise programme. The exercise will be remotely monitored since the first gestational trimester until delivery

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Diana Bernardo

Porto, Portugal

Outcomes

Primary Outcomes

Gestational Weight Gain

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.

Time frame: At delivery

Excessive gestational weight gain

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.

Time frame: At delivery

Secondary Outcomes

Low Back Pain

Oswestry Low Back Pain Disability Questionnaire (ODI v2.0)

Time frame: At first, second and third gestational trimester

Subjective Physical Activity assessment

Pregnancy Physical Activity Questionnaire (PPAQ) is a self-reported questionnaire. The objective is measure the type and intensity of pregnant women physical activity.

Time frame: At first, second and third gestational trimester

Objective Physical Activity assessment

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)

Time frame: At first, second and third gestational trimester

Gestational Diabetes Mellitus

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.

Data from ClinicalTrials.gov

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