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临床试验/NCT06954454
NCT06954454招募中不适用

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

Polytechnic University of Santarém6 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2025年4月24日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
250
试验地点
6
主要终点
Upper limbs strength

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

盲法说明

Data analyst are masked.

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Upper limbs strength

时间窗: Baseline (week 0) and after 12-week intervention (week 13)

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

Lower limbs strength

时间窗: Baseline (week 0) and after 12-week intervention (week 13)

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

Dynamic balance

时间窗: Baseline (week 0) and after 12-week intervention (week 13)

Dynamic balance - tandem walk.

Static balance

时间窗: Baseline (week 0) and after 12-week intervention (week 13)

Static balance - One Leg Stance.

Lower limbs flexibility

时间窗: Baseline (week 0) and after 12-week intervention (week 13)

Lower limbs flexibility - modified sit and reach (mm)

Upper limbs flexibility

时间窗: Baseline (week 0) and after 12-week intervention (week 13)

Upper limbs flexibility - back scratch (mm).

Agility

时间窗: Baseline (week 0) and after 12-week intervention (week 13)

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

Self-perceived fitness

时间窗: 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

时间窗: 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)

Physical activity

时间窗: 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

次要结局

  • 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))
  • Heart rate(Baseline (week 0) and after 12-week intervention (week 13))
  • Pregnancy-related symptoms(Baseline (week 0) and after 12-week intervention (week 13))

研究者

发起方
Polytechnic University of Santarém
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rita Santos-Rocha

Professor

Polytechnic University of Santarém

研究点 (6)

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