Clinical trial NCT06954454: Impact of In-Person Versus Online Supervised Multicenter Multicomponent Prenatal Exercise Program on Maternal Physical Activity, Fitness, and Healthy Lifestyle
Official title: Impact of In-Person Versus Online Supervised Multicenter Multicomponent Prenatal Exercise Program on Maternal Physical Activity, Fitness, and Healthy Lifestyle - The Active Pregnancy Trial Protocol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnant Women Participating in a Supervised Multicomponent Exercise Intervention
Keywords: pregnancy
physical activity
exercise
fitness
women
exercise prescription
Lead sponsor: Polytechnic University of Santarém
Sponsor class: OTHER
Collaborators: name: SPRINT Sport Physical Activity and Health Research & Innovation Center
First posted: 2025-05-01
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm 1: In-Person Exercise Group (IN) Type of exercise: multicomponent prenatal exercise program including aerobic, coordination, strength, stretching, balance, postural, and pelvic floor muscle training exercises.

Duration and frequency: two sessions of 60 minutes per week for 12 weeks. In-person supervision: qualified exercise physiologists. Setting: healthcare, university, or fitness centers. Arm 2: Online Exercise Group (ON) Type of exercise: multicomponent prenatal exercise program including aerobic, coordination, strength, stretching, balance, postural, and pelvic floor muscle training exercises.

Duration and frequency: two sessions of 60 minutes per week for 12 weeks. Remote supervision using a virtual platform: qualified exercise physiologists. Setting: home or outdoors. Additional recommendations include educational materials (Active Pregnancy Guide), walking, swimming, or performing a video session from the Active Pregnancy Guide Channel on other days of the week.
Primary purpose: TREATMENT

Brief summary: Many studies have been supporting the positive effects of an active lifestyle concerning the prevention and treatment of pregnancy-related complications and health problems, such as gestational diabetes, gestational hypertension, obesity, low back pain, urinary incontinence, anxiety or depression, as well as regarding its effectiveness in maintaining fitness and functionality, and in improving postpartum recovery.

Practice and clinical guidelines have become increasingly popular tools for synthesizing evidence-based information to assist practitioners and patients/participants in making decisions related to starting or continuing physical activity.

Despite this knowledge, most women still do not receive proper guidance on how to exercise during pregnancy or after childbirth, and the prevalence of physical inactivity is still high among pregnant and postpartum women. On the other hand, the COVID-19 pandemic has highlighted the need for virtual approaches in health interventions, but few studies have addressed the effectiveness of such interventions.

This study is about the benefits of exercising during pregnancy in terms of maternal physical activity, fitness, and healthy lifestyle parameters. After the first visit to the doctor, pregnant women without absolute contraindications to exercise will be invited to participate in a multi-site (fitness center, university, or hospital) prenatal exercise program delivered either in person or online by qualified exercise physiologists.

The exercise intervention will follow international evidence-based guidelines. It includes aerobic, coordination, strength, postural, stretching, and pelvic floor exercises, organized in two weekly sessions lasting 60 minutes each.

Pregnant women will be asked to answer questionnaires about physical activity, fitness, and healthy lifestyle parameters (sleep, diet, stress) twice: before starting the exercise program and after completing 12 weeks of the program. The same procedure applies to basic fitness field tests (e.g., to assess balance, flexibility, strength, cardiorespiratory fitness, etc.).

Participants will have access to the free Active Pregnancy Guide (including recommendations for walking, dancing, swimming, etc.). On other days of the week, they can follow specific workouts on the YouTube channel (@GravidezAtiva-ActivePregnancy).

Researchers will test whether the exercise program is beneficial in maintaining or improving maternal physical activity and fitness levels and healthy lifestyle parameters after 12 weeks. Moreover, researchers will compare which exercise mode (in-person or virtual) is better or similar. Participants will also be asked about their satisfaction with the intervention and educational resources. Participation and resources will be free. All participants will benefit from the exercise intervention.

The study's results will contribute to knowledge on this topic, inform future exercise recommendations for pregnant women, and inform public health strategies.

Detailed description: Scientific studies have been supporting the positive effects of an active lifestyle concerning the prevention and treatment of pregnancy-related complications and health problems, such as gestational diabetes, gestational hypertension, obesity, low back pain, urinary incontinence, anxiety or depression, as well as regarding its effectiveness in maintaining fitness and functionality, and in improving postpartum recovery.

Practice and clinical guidelines have become increasingly popular tools for synthesizing evidence-based information to assist practitioners and patients/participants in deciding to start or continue physical activity.

Despite this knowledge, most women still do not receive proper guidance on how to exercise during pregnancy or after childbirth, and the prevalence of physical inactivity is still high among pregnant and postpartum women. On the other hand, the COVID-19 pandemic has highlighted the need for virtual approaches in health interventions, but few studies have addressed the effectiveness of such interventions.

This trial will compare the effectiveness of in-person versus online supervised prenatal exercise programs on improving maternal physical activity, functional fitness, healthy lifestyle parameters, and health outcomes. After the first visit to the doctor, pregnant women without absolute contraindications to exercise will be invited to participate in a multi-site (home, fitness center, university, or hospital) prenatal exercise program delivered either in person or online. The study will be conducted in multiple centers, recruiting women between 13-20 gestational weeks, allocated to in person or online exercise groups for 12 weeks. The exercise intervention will follow international evidence-based guidelines. It includes aerobic, coordination, strength, postural, stretching, and pelvic floor exercises, organized in two weekly sessions lasting 60 minutes each. All sessions will be supervised by qualified exercise physiologists.

Assessments include validated questionnaires (PPAQ, IFIS, etc.) and fitness tests, at baseline and post-intervention. Pregnant women will be asked to answer questionnaires about physical activity (PPAQ), fitness (IFIS), and healthy lifestyle parameters (health, sleep, diet, stress) twice: before starting the exercise program and after completing 12 weeks of the program. The same procedure applies to basic fitness field tests (e.g., to assess balance, flexibility, strength, cardiorespiratory fitness, etc.). All tests will be applied by qualified exercise physiologists.

Demographic data (age, BMI, gestational age) will be described using frequencies and percentages for categorical variables. Descriptive statistics (mean, standard deviation, median, interquartile range) will be used to summarize baseline characteristics of participants in both groups (IN and ON). Descriptive and inferential statistics will be applied to all outcomes. Comparative analysis of IN vs. ON interventions will be conducted using intention-to-treat and per-protocol approaches. Comparative analysis will be used to compare changes in primary (physical activity, health-related, and functional fitness) and secondary (lifestyle parameters) outcomes between IN and ON groups over time (baseline and post-intervention). Subgroup analyses will evaluate potential differences regarding maternal age groups (20-34 years vs. 35-50 years). Adjustments will be performed for potential confounders (e.g., maternal age, baseline fitness levels). The significance level of 0.05 (alpha level) will be set for all statistical tests. Power calculations were performed to ensure the study is adequately powered to detect clinically significant differences between groups. For categorical variables, comparative analysis will be performed using chi-square tests or Fisher's exact tests.

Regarding additional outcome analysis, the evaluation of interventions and resources will be performed by means of descriptive analysis summarizing the usage and satisfaction with resources (Active Pregnancy Guide, Active Pregnancy YouTube channel, and Active Pregnancy app) and satisfaction with exercise interventions.

The statistical software SPSS will be used for data analysis. The study has obtained ethics approval from relevant institutional boards. All participants will be informed about the benefits and objectives of the study. Participation in the exercise programs and assessments is free, and they can leave any time without any consequences. Exercise interventions will be supervised and delivered by qualified exercise physiologists and medical records will be obtained by medical doctors. All educational resources will be available for free. Participant confidentiality will be maintained.

Participants will have access to the free Active Pregnancy Guide (including recommendations for walking, dancing, swimming, etc.). On other days of the week, they can follow specific workouts on the YouTube channel (@GravidezAtiva-ActivePregnancy).

Participants will also be asked about their satisfaction with the intervention and educational resources. Participation and resources will be free. All participants will benefit from the exercise intervention.

The study's results will contribute to knowledge on this topic, inform future exercise recommendations for pregnant women, and inform public health strategies.

Eligibility criteria: Inclusion Criteria:

* Pregnant women between 13 and 20 gestational weeks at baseline
* Age: 18-50 years
* No absolute contraindications to exercise
* Understand the Portuguese language

Exclusion Criteria:

* Any absolute contraindications to exercise as per guidelines
* High-risk pregnancy conditions requiring physical activity restrictions

Primary outcomes:
measure: Physical activity
timeFrame: Baseline (week 0) and after 12-week intervention (week 13)
measure: Self-perceived fitness
timeFrame: Baseline (week 0) and after 12-week intervention (week 13)
measure: Cardiorespiratory fitness
timeFrame: Baseline (week 0) and after 12-week intervention (week 13)
measure: Upper limbs strength
timeFrame: Baseline (week 0) and after 12-week intervention (week 13)
measure: Lower limbs strength
timeFrame: Baseline (week 0) and after 12-week intervention (week 13)
measure: Dynamic balance
timeFrame: Baseline (week 0) and after 12-week intervention (week 13)
measure: Static balance
timeFrame: Baseline (week 0) and after 12-week intervention (week 13)
measure: Lower limbs flexibility
timeFrame: Baseline (week 0) and after 12-week intervention (week 13)
measure: Upper limbs flexibility
timeFrame: Baseline (week 0) and after 12-week intervention (week 13)
measure: Agility
timeFrame: Baseline (week 0) and after 12-week intervention (week 13)
Secondary outcomes:
measure: Sleep
timeFrame: Baseline (week 0) and after 12-week intervention (week 13)
measure: Weight
timeFrame: Baseline (week 0) and after 12-week intervention (week 13)
measure: Happiness
timeFrame: Baseline (week 0) and after 12-week intervention (week 13)
measure: Depression
timeFrame: Baseline (week 0) and after 12-week intervention (week 13)
measure: Diet
timeFrame: Baseline (week 0) and after 12-week intervention (week 13)
measure: Heart rate
timeFrame: Baseline (week 0) and after 12-week intervention (week 13)
measure: Pregnancy-related symptoms
timeFrame: Baseline (week 0) and after 12-week intervention (week 13)
Other outcomes:
measure: Satisfaction with the intervention
timeFrame: After the intervention (13-14 weeks)
measure: Feasibility and adherence
timeFrame: After the intervention (weeks 13-14)
Locations:
city: Braga
country: Portugal
facility: School of Medicine - University of Minho
city: Rio Maior
country: Portugal
facility: Sport Sciences School of Rio Maior - Polytechnic University of Santarem
city: Santarem
country: Portugal
facility: Health School of Santarem - Polytechnic University of Santarem
Study officials:
affiliation: Polytechnic University of Santarém
name: Rita Santos-Rocha, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Santos-Rocha R, Pajaujiene S, Szumilewicz A. ACTIVE PREGNANCY: Workshop on Promotion of Physical Activity in Pregnancy for Exercise Professionals. J Multidiscip Healthc. 2022 Sep 14;15:2077-2089. doi: 10.2147/JMDH.S370453. eCollection 2022.
citation: Santos-Rocha R, Ferreira M, Pimenta N, Branco M, Oviedo-Caro M, Szumilewicz A. Understanding and Involving the Perspective of Pregnant Women as Users When Designing the Framework of e-Health and Exercise Interventions during Pregnancy: Preliminary Study. Healthcare (Basel). 2024 May 30;12(11):1121. doi: 10.3390/healthcare12111121.
citation: Santos-Rocha R, Fernandes de Carvalho M, Prior de Freitas J, Wegrzyk J, Szumilewicz A. Active Pregnancy: A Physical Exercise Program Promoting Fitness and Health during Pregnancy-Development and Validation of a Complex Intervention. Int J Environ Res Public Health. 2022 Apr 18;19(8):4902. doi: 10.3390/ijerph19084902.