Remotely Monitored Exercise Program in Pregnant Women With Obesity (GROB)

Universidade do Porto

Status: Unknown

Conditions: Obesity, Maternal; Pregnancy Related

Treatments: Behavioral: Remote Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05331586

0000

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

control intervention

No Intervention group

Description:

The control group will receive the standard prenatal care in Hospital Center of São Joao (CHUSJ). The standard prenatal care will be regular appointments with obstetrician and midwife nurses, ultrasounds and nutritional appointments. The pregnant women in control group will also receive a pamphlet with the benefits of physical exercise during pregnancy and recommendations for adequate gestational weight gain. Pregnant women in control group will not be discouraged from exercising on their own.

Exercise intervention

Experimental group

Description:

The exercise group intervention will perform home-based remotely monitored exercise

Treatment:

Behavioral: Remote Exercise