Impact of In-Person Versus Online Supervised Multicenter Multicomponent Prenatal Exercise Program on Maternal Physical Activity, Fitness, and Healthy Lifestyle

NCT06954454 | Recruiting

• 1 other identifier: 2023.14896.PEX
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 3

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.

Conditions

Pregnant Women Participating in a Supervised Multicomponent Exercise Intervention

Keywords

pregnancy; physical activity; exercise; fitness; women; exercise prescription

Outcome Measures

Primary Outcomes (10)

• 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

  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

  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)

  Baseline (week 0) and after 12-week intervention (week 13)

• Upper limbs strength

  Upper limbs strength - wall push-ups (number of repetitions in 30s)

  Baseline (week 0) and after 12-week intervention (week 13)

• Lower limbs strength

  Lower limbs strength - sit-and-stand (number of repetitions in 30s)

  Baseline (week 0) and after 12-week intervention (week 13)

• Dynamic balance

  Dynamic balance - tandem walk.

  Baseline (week 0) and after 12-week intervention (week 13)

• Static balance

  Static balance - One Leg Stance.

  Baseline (week 0) and after 12-week intervention (week 13)

• Lower limbs flexibility

  Lower limbs flexibility - modified sit and reach (mm)

  Baseline (week 0) and after 12-week intervention (week 13)

• Upper limbs flexibility

  Upper limbs flexibility - back scratch (mm).

  Baseline (week 0) and after 12-week intervention (week 13)

• Agility

  Agility - Time Up \& Go over 3 m distance (in min).

  Baseline (week 0) and after 12-week intervention (week 13)

Secondary Outcomes (7)

• Sleep

  Baseline (week 0) and after 12-week intervention (week 13)

• Weight

  Baseline (week 0) and after 12-week intervention (week 13)

• Happiness

  Baseline (week 0) and after 12-week intervention (week 13)

• Depression

  Baseline (week 0) and after 12-week intervention (week 13)

• Diet

  Baseline (week 0) and after 12-week intervention (week 13)

Other Outcomes (2)

• Satisfaction with the intervention

  After the intervention (13-14 weeks)

• Feasibility and adherence

  After the intervention (weeks 13-14)

Study Arms (2)

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.

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.

Other: prenatal physical exercise intervention

Interventions

prenatal physical exercise intervention OTHER

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).

Also known as: physical activity and healthy lifestyle promotion

Arm 1: In-Person Exercise Group (IN); Arm 2: Online Exercise Group (ON)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Polytechnic University of Santarém: lead
• SPRINT Sport Physical Activity and Health Research & Innovation Center: collaborator

Study Sites (3)

School of Medicine - University of Minho

Braga, 4710-057, Portugal

NOT YET RECRUITING

Sport Sciences School of Rio Maior - Polytechnic University of Santarem

Rio Maior, 2040-413, Portugal

RECRUITING

Health School of Santarem - Polytechnic University of Santarem

Santarém, 2005-075, Portugal

NOT YET RECRUITING

Related Publications (4)

• 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.

  PMID: 36128597 BACKGROUND

• 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.

  PMID: 38891196 BACKGROUND

• 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.

  PMID: 35457769 BACKGROUND

• Santos-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.

  PMID: 40657545 DERIVED

Related Links

• Project website
• Project YouTube channel

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Rita Santos-Rocha, Ph.D.

  Polytechnic University of Santarém

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rita Santos-Rocha, Ph.D.

CONTACT

+351966036856; ritasantosrocha@esdrm.ipsantarem.pt

Cristina Nogueira-Silva, Ph.D/M.D.

CONTACT

+351916721321; cristinasilva@med.uminho.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Data analyst are masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: May 1, 2025
• Study Start: April 24, 2025
• Primary Completion (Estimated): October 24, 2026
• Study Completion (Estimated): April 24, 2027
• Last Updated: June 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 3 years after the publication of results.
• Access Criteria: De-identified data will be shared on request.

Locations

PT (3)