Pregnant Women Participating in a Supervised Multicomponent Exercise InterventionActivePregnancNCT06954454
Impact of In-Person Versus Online Supervised Multicenter Multicomponent Prenatal Exercise Program on Maternal Physical Activity, Fitness, and Healthy Lifestyle
A study testing prenatal physical exercise intervention in people with Pregnant Women Participating in a Supervised Multicomponent Exercise Intervention, run by Polytechnic University of Santarém at 3 sites in Portugal.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pregnant Women Participating in a Supervised Multicomponent Exercise Intervention
- What is being tested?
- prenatal physical exercise intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 3 sitesPortugal
- Study dates
- 24 Apr 2025to 24 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women between 13 and 20 gestational weeks at baseline
- Age: 18-50 years
- No absolute contraindications to exercise
- Understand the Portuguese language
Who cannot join
- Any absolute contraindications to exercise as per guidelines
- High-risk pregnancy conditions requiring physical activity restrictions
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal3 sites, 3 recruiting
- Not yet recruiting
School of Medicine - University of Minho
Braga, 4710-057
Cristina Nogueira-Silva, Ph.D./M.D., +351916721321, cristinasilva@med.uminho.pt
Cristina Nogueira-Silva, Ph.D./M.D.
- Recruiting
Sport Sciences School of Rio Maior - Polytechnic University of Santarem
Rio Maior, 2040-413
Nuno Pimenta, Ph.D., +351918687518, npimenta@esdrm.ipsantarem.pt
Susana Franco, Ph.D., +351967021471, sfranco@esdrm.ipsantarem.pt
- Not yet recruiting
Health School of Santarem - Polytechnic University of Santarem
Santarém, 2005-075
Hélia Dias, Ph.D., +351912251657, helia.dias@essaude.ipsantarem.pt
Alcinda Reis, Ph.D., +351917167661, alcinda.reis@essaude.ipsantarem.pt
About this study
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
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.
Read more
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.
Read the 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.
- Being tested
- prenatal physical exercise intervention
- Keywords
- pregnancy, physical activity, exercise, fitness, women, exercise prescription
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prenatal physical exercise interventionOther
Also called physical activity and healthy lifestyle promotion
Multicomponent prenatal exercise program including aerobic, coordination, strength, stretching, balance, postural, and pelvic floor muscle training exercises. Delivered either in person or online by qualified exercise physiologists. Duration and frequency: two sessions of 60 minutes per week for 12 weeks. Moderate intensity: According to the Borg scale of perceived exertion, from six to 20, moderate exercise is rated between 13 and 14. Each pregnant woman will rate her exercise on the Borg perceived exertion scale from six to 20. Settings: home or healthcare, university, or fitness centers. Following international guidelines for physical activity during pregnancy (ACOG-USA, ACSM-USA, CSEP-Canada, PSOG-Poland, SEGO-Spain).
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: In-Person Exercise Group (IN) | Active comparator | Arm 1: In-Person Exercise Group (IN) Type of exercise: multicomponent prenatal exercise program. Program duration: 12 weeks. Frequency: two weekly sessions. Session duration: 60 minutes. Intensity: moderate. Supervision: qualified exercise physiologists. Setting: healthcare, university, or fitness centers. Receives: Other: prenatal physical exercise intervention |
| Arm 2: Online Exercise Group (ON) | Active comparator | Arm 2: Online Exercise Group (ON) Type of exercise: multicomponent prenatal exercise program. Program duration: 12 weeks. Frequency: two weekly sessions. Session duration: 60 minutes. Intensity: moderate. Supervision: qualified exercise physiologists. Setting: home or outdoors. Receives: Other: prenatal physical exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
Level and pattern of physical activity in type of PA (work, active commuting, exercise, etc.), type of exercise, duration of each session (time spent in PA), weekly frequency, and intensity, weekly volume. Pregnancy Physical Activity Questionnaire (PPAQ) and Get Active Questionnaire for Pregnancy
Measured: Baseline (week 0) and after 12-week intervention (week 13)
Self-perceived fitness
Self-perceived global fitness and fitness components (cardiorespiratory, strength, speed/agility, flexibility) when compared to other women of the same age. Lickert scale 1 (poor) to 5 (very good). IFIS International Fitness Scale
Measured: Baseline (week 0) and after 12-week intervention (week 13)
Cardiorespiratory fitness
Cardiorespiratory fitness - 6-min walk test (average distance covered in m and estimated cardiorespiratory fitness in mL/Kg/min)
Measured: Baseline (week 0) and after 12-week intervention (week 13)
Upper limbs strength
Upper limbs strength - wall push-ups (number of repetitions in 30s)
Measured: Baseline (week 0) and after 12-week intervention (week 13)
Lower limbs strength
Lower limbs strength - sit-and-stand (number of repetitions in 30s)
Measured: Baseline (week 0) and after 12-week intervention (week 13)
Dynamic balance
Dynamic balance - tandem walk.
Measured: Baseline (week 0) and after 12-week intervention (week 13)
Static balance
Static balance - One Leg Stance.
Measured: Baseline (week 0) and after 12-week intervention (week 13)
Lower limbs flexibility
Lower limbs flexibility - modified sit and reach (mm)
Measured: Baseline (week 0) and after 12-week intervention (week 13)
Upper limbs flexibility
Upper limbs flexibility - back scratch (mm).
Measured: Baseline (week 0) and after 12-week intervention (week 13)
Agility
Agility - Time Up \& Go over 3 m distance (in min).
Measured: Baseline (week 0) and after 12-week intervention (week 13)
Secondary outcomes (7)
Sleep
Sleep: PSQI Pittsburgh Sleep Quality Index
Measured: Baseline (week 0) and after 12-week intervention (week 13)
Weight
Pre-pregnancy, weight at baseline and weight gain (Kg)
Measured: Baseline (week 0) and after 12-week intervention (week 13)
Happiness
Happiness: SHS Subjective Happiness Scale
Measured: Baseline (week 0) and after 12-week intervention (week 13)
Depression
Depression: EPDS Edinburgh Postpartum Depression Scale.
Measured: Baseline (week 0) and after 12-week intervention (week 13)
Diet
Diet: MEDAS Mediterranean Diet Adherence Screener.
Measured: Baseline (week 0) and after 12-week intervention (week 13)
Heart rate
Rest heart rate (bat/min)
Measured: Baseline (week 0) and after 12-week intervention (week 13)
Pregnancy-related symptoms
Prevalence of pregnancy-related symptoms. Medical records and Get Active Questionnaire for Pregnancy.
Measured: Baseline (week 0) and after 12-week intervention (week 13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start24 Apr 2025
- Primary completion24 Oct 2026 (estimated)
- Study completion24 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pregnant Women Participating in a Supervised Multicomponent Exercise InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Polytechnic University of Santarém
- Sponsor type
- University, hospital or other
- Collaborators
- SPRINT Sport Physical Activity and Health Research & Innovation Center
- Responsible party
- Principal investigator, Rita Santos-Rocha, Polytechnic University of Santarém
- Investigators
- Rita Santos-Rocha, Ph.D., Principal investigator, Polytechnic University of Santarém
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954454
- Sponsor's protocol ID
- 2023.14896.PEX
- Other IDs
- 2023
- Acronym
- ActivePregnanc
- Status last verified
- Apr 2025
- First submitted
- 16 Apr 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Publications
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.
PubMed 38891196Santos-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.
PubMed 36128597Santos-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.
PubMed 35457769Santos-Rocha R, Branco M, Prior de Freitas J, Castro B, Pinto AT, Silva-Santos S, Nogueira-Silva C, Oviedo-Caro MA, Szablewska A, Szumilewicz A. Impact of in-person versus online supervised multicentre multicomponent prenatal exercise programme on maternal physical activity, fitness and healthy lifestyle: the Active Pregnancy trial SPIRIT 2025-based protocol. BMJ Open Sport Exerc Med. 2025 Jul 11;11(3):e002767. doi: 10.1136/bmjsem-2025-002767. eCollection 2025.
PubMed 40657545
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06954454
- Acronym / sponsor ID
- ActivePregnanc / 2023.14896.PEX
- Keywords
- pregnancy, physical activity, exercise, fitness, women, exercise prescription
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Polytechnic University of SantarémUniversity, hospital or other
- Collaborators
- SPRINT Sport Physical Activity and Health Research & Innovation Center
- Study start
- 24 Apr 2025 (actual)
- Primary completion
- 24 Oct 2026 (estimated)
- Study completion
- 24 Apr 2027 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: In-Person Exercise Group (IN) | Active comparator | Other: prenatal physical exercise interventionArm 1: In-Person Exercise Group (IN) Type of exercise: multicomponent prenatal exercise program. Program duration: 12 weeks. Frequency: two weekly sessions. Session duration: 60 minutes. Intensity: moderate. Supervision: qualified exercise physiologists. Setting: healthcare, university, or fitness centers. |
| Arm 2: Online Exercise Group (ON) | Active comparator | Other: prenatal physical exercise interventionArm 2: Online Exercise Group (ON) Type of exercise: multicomponent prenatal exercise program. Program duration: 12 weeks. Frequency: two weekly sessions. Session duration: 60 minutes. Intensity: moderate. Supervision: qualified exercise physiologists. Setting: home or outdoors. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant women between 13 and 20 gestational weeks at baseline
- Age: 18-50 years
- No absolute contraindications to exercise
- Understand the Portuguese language
Key exclusion criteria (2 listed)
- Any absolute contraindications to exercise as per guidelines
- High-risk pregnancy conditions requiring physical activity restrictions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prenatal physical exercise interventionAlso: physical activity and healthy lifestyle promotionMulticomponent prenatal exercise program including aerobic, coordination, strength, stretching, balance, postural, and pelvic floor muscle training exercises. Delivered either in person or online by qualified exercise physiologists. Duration and frequency: two sessions of 60 minutes per week for 12 weeks. Moderate intensity: According to the Borg scale of perceived exertion, from six to 20, moderate exercise is rated between 13 and 14. Each pregnant woman will rate her exercise on the Borg perceived exertion scale from six to 20. Settings: home or healthcare, university, or fitness centers. Following international guidelines for physical activity during pregnancy (ACOG-USA, ACSM-USA, CSEP-Canada, PSOG-Poland, SEGO-Spain). | Other | Arm 1: In-Person Exercise Group (IN), Arm 2: Online Exercise Group (ON) |
Primary outcome
Physical activity
Time frame: Baseline (week 0) and after 12-week intervention (week 13)
Level and pattern of physical activity in type of PA (work, active commuting, exercise, etc.), type of exercise, duration of each session (time spent in PA), weekly frequency, and intensity, weekly volume. Pregnancy Physical Activity Questionnaire (PPAQ) and Get Active Questionnaire for Pregnancy
Self-perceived fitness
Time frame: Baseline (week 0) and after 12-week intervention (week 13)
Self-perceived global fitness and fitness components (cardiorespiratory, strength, speed/agility, flexibility) when compared to other women of the same age. Lickert scale 1 (poor) to 5 (very good). IFIS International Fitness Scale
Cardiorespiratory fitness
Time frame: Baseline (week 0) and after 12-week intervention (week 13)
Cardiorespiratory fitness - 6-min walk test (average distance covered in m and estimated cardiorespiratory fitness in mL/Kg/min)
Upper limbs strength
Time frame: Baseline (week 0) and after 12-week intervention (week 13)
Upper limbs strength - wall push-ups (number of repetitions in 30s)
Lower limbs strength
Time frame: Baseline (week 0) and after 12-week intervention (week 13)
Lower limbs strength - sit-and-stand (number of repetitions in 30s)
Dynamic balance
Time frame: Baseline (week 0) and after 12-week intervention (week 13)
Dynamic balance - tandem walk.
Static balance
Time frame: Baseline (week 0) and after 12-week intervention (week 13)
Static balance - One Leg Stance.
Lower limbs flexibility
Time frame: Baseline (week 0) and after 12-week intervention (week 13)
Lower limbs flexibility - modified sit and reach (mm)
Upper limbs flexibility
Time frame: Baseline (week 0) and after 12-week intervention (week 13)
Upper limbs flexibility - back scratch (mm).
Agility
Time frame: Baseline (week 0) and after 12-week intervention (week 13)
Agility - Time Up \& Go over 3 m distance (in min).
7 secondary outcomes
Sleep
Time frame: Baseline (week 0) and after 12-week intervention (week 13)
Weight
Time frame: Baseline (week 0) and after 12-week intervention (week 13)
Happiness
Time frame: Baseline (week 0) and after 12-week intervention (week 13)
Depression
Time frame: Baseline (week 0) and after 12-week intervention (week 13)
Diet
Time frame: Baseline (week 0) and after 12-week intervention (week 13)
Heart rate
Time frame: Baseline (week 0) and after 12-week intervention (week 13)
Pregnancy-related symptoms
Time frame: Baseline (week 0) and after 12-week intervention (week 13)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Background: PubMed 38891196Santos-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.
- Results publication: PubMed 36128597Santos-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.
- Results publication: PubMed 35457769Santos-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.
- Derived from this study: PubMed 40657545Santos-Rocha R, Branco M, Prior de Freitas J, Castro B, Pinto AT, Silva-Santos S, Nogueira-Silva C, Oviedo-Caro MA, Szablewska A, Szumilewicz A. Impact of in-person versus online supervised multicentre multicomponent prenatal exercise programme on maternal physical activity, fitness and healthy lifestyle: the Active Pregnancy trial SPIRIT 2025-based protocol. BMJ Open Sport Exerc Med. 2025 Jul 11;11(3):e002767. doi: 10.1136/bmjsem-2025-002767. eCollection 2025.
- Project websiteLink provided by the sponsor.
- Project YouTube channelLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rita Santos-Rocha, Ph.D. principal investigator
Polytechnic University of Santarém
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prenatal physical exercise intervention in people with Pregnant Women Participating in a Supervised Multicomponent Exercise Intervention, run by Polytechnic University of Santarém at 3 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rita Santos-Rocha, Ph.D. (+351966036856, ritasantosrocha@esdrm.ipsantarem.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity (time frame: Baseline (week 0) and after 12-week intervention (week 13)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06954454, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.