PregFit Adventure: Strengthening Mothers-to-Be (PregFit)

1. PROJECT DATA

PI (Name and surname): Martínez Vázquez, Sergio; svazquez@ujaen.es; Tel: +34 953212014

PregFit Adventure: Strengthening Mothers-to-Be 2. SCIENTIFIC EXCELLENCE, NOVELTY AND RELEVANCE OF THE PROPOSAL.

It is estimated that up to 5 million deaths per year could be avoided if the world's population were more physically active. Therefore, the World Health Organization (WHO) promulgates guidelines on physical activity and sedentary lifestyles, emphasizing that all people, regardless of age or ability, can be active and that any movement counts. Physical activity, is defined as any bodily movement produced by the contraction of skeletal muscles. Exercise, on the other hand, is defined as physical activity consisting of planned, structured, repetitive body movements performed to improve one or more components of physical fitness. It is an essential element that is part of a healthy lifestyle, and obstetrics-gynecology professionals as well as other obstetric care professionals should encourage women to continue or begin exercising as an important component of optimal health.

There are recommendations for at least 150 minutes of moderate-intensity aerobic activity per week during pregnancy and postpartum. The guidelines recommend that women who routinely engaged in vigorous-intensity aerobic activity or who were physically active before pregnancy can continue these activities during pregnancy and postpartum. In addition, pregnant women should be under the care of an obstetrics-gynecology professional who can monitor the progress of the pregnancy.

Physical inactivity is the fourth leading risk factor for early mortality worldwide. During pregnancy, physical inactivity and excessive weight gain have been recognized as independent risk factors for maternal obesity and pregnancy-related complications, including gestational diabetes mellitus (GDM). It also reduces the risk of excessive gestational weight gain, gestational hypertensive disorders, low birth weight, preterm delivery, or cesarean section.

There is no evidence that regular physical activity during pregnancy can cause miscarriage, poor fetal growth, musculoskeletal injury, or preterm delivery in women with uncomplicated pregnancies. In addition, regular physical activity has been associated with an increased likelihood of having a vaginal delivery. In the absence of obstetric and medical complications or contraindications, physical activity during pregnancy is safe and desirable, and pregnant women should be encouraged to continue or initiate safe physical activities. Some of these activities defined as safe include: walking, stationary cycling, aerobic exercise, dancing, resistance exercises (e.g., weights, elastic bands), stretching exercises, hydrotherapy, or water aerobics.

Ring Fit Adventure is an interactive exercise game for the Nintendo Switch console that combines physical activity with elements of play and fun. The game involves stretching movements, balance, and moderate aerobic exercise, which can be beneficial if performed properly. The intensity of the exercise can vary and it is important for pregnant women to adjust their effort so as not to overtax their bodies. It defeats monsters through exercise, shoulder presses, or yoga poses. It has a holder ring, this is a control device that is used for resistance exercises, and there is also a leg strap that tracks running pace. The game is not specifically designed for pregnant women, and some movements, such as jumping or performing certain quick stretches, may not be appropriate during advanced pregnancy, although, when starting, the game performs some tests to gauge strength, running speed, and intensity level. In addition, it has an "assisted mode," which allows adjustments for shoulder accessibility, knee assistance, back assistance, or ab assistance. For example, instead of doing a squat or ring squeeze, a button is pressed or cool-down periods are given for repeat attacks allowing the woman to rest.

Nintendo Ring Fit Adventure, considered an "exergame" or games that encourage exercise while playing, has been shown to be effective in older adult populations by significantly improving muscle mass, strength and functionality or reducing falls in different clinical trials. The results are also very positive if the study population had musculoskeletal problems, osteoarthritis or chronic low back pain. Benefits related to weight loss in overweight and obese patients have also been described.

However, there are hardly any studies carried out in pregnant women that propose physical exercise interventions and then evaluate the effect that these interventions have on their physical condition or level of physical activity. Moreover, the few studies that contemplate this type of approach use recommendations and physical exercise guidelines that do not take into account new technologies or immersive gamification, such as exergames. Therefore, the objective is to evaluate an exergame-based exercise training program administered through Nintendo Ring Fit Adventure and to study its effect on the physical condition of pregnant women and their level of activity. 3. RESEARCH TEAM

Sergio Martínez Vázquez (IP) (SMV) - Professor - University of Jaén

4\. OBJECTIVES AND HYPOTHESES

Hypothesis: After participating in the Exergame-based training program using Ring Fit Adventure, pregnant women will improve their self-perceived physical fitness and physical activity level, showing a statistically significant increase in both indices.

General Objective: To evaluate an exergame-based exercise training program administered through Nintendo Ring Fit Adventure and to study its effect on the fitness and physical activity level of pregnant women.

In order to achieve the general objective, the following specific objectives are set:

1. Determine the physical condition and physical activity level of pregnant women prior to training. 2. To determine the physical condition and physical activity level of pregnant women after training.

5\. METHODOLOGY

1. Design.

This will be a randomized clinical trial (RCT) with two groups, an experimental or intervention group and a control group. 2. Population, criteria, sample, calculation.

The study population will be low-risk pregnant women.

Inclusion criteria:

• Pregnant women at low obstetric risk and with no musculoskeletal or health problems affecting their physical condition, ability to exercise or participate in the exergame activities.

• Read the information sheet and sign the informed consent form to agree to take part in the study. * \>18 years of age * Spanish comprehension and communication skills * Able to perform physical activity related to the use of the device for at least 30 minutes, 2-3 times a week, for at least 8 weeks

Exclusion criteria:

• Failure to meet any of the inclusion criteria

• Giving birth during the procedure and at least 8 weeks of device use have not elapsed.

Assignment: All women receiving maternal education from all participating health centers will be randomized to ensure that there is no sample contamination and their relevance to the intervention or control group will be established according to randomization.

Sample size calculation: It was estimated that the number of participants should be at least 15% for this pilot study of what would be a future intervention project. Using self-perceived physical fitness as the dependent variable, and in validation studies having had samples of around 160 women, at least 24 women will be needed in the single intervention group for this pilot study. Similarly, at least 24 women in the control group are needed for comparison. It is estimated that 20% of women may drop out of the intervention before the minimum 8 weeks, thus establishing a sample size of at least 30 women to recruit. Using similar studies as a reference, we will try to reach the ideal sample size of 42 healthy pregnant women who complete the intervention and at least 42 for the control group who receive routine pregnancy follow-up EpS and antenatal classes. 3. Description of the intervention.

@Intervention Group: The program consists of using the device, a minimum of 30 minutes per session two to three times per week and not exceeding ≥3 hours, for at least 8 weeks up to a maximum of 3 months or until the onset of discomfort disabling physical activity, with the minimum time for intervention being at least 8 weeks. Exercise based on exergames will be performed including at least 10 minutes of warm-up and 10 minutes of cool-down, and under the supervision of a licensed health professional.

The training program will focus on strength and functional movements. It requires a Nintendo Switch console, a Ring-Con (a Pilates ring that the user holds or ring holder), wireless Joy-Con controllers (the right Joy-Con, connected to the Ring-Con; and the left Joy-Con, attached to the strap around the player's thigh) and a screen. In adventure mode, women will move through the game by performing physical activities such as jogging or doing squats. To minimize risk, knee-assist mode will be used, which makes the game more accessible. Activating knee assist mode provides support when women perform exercises that require walking, kneeling or squatting, making these activities easier for pregnant women, increasing the fitness benefits of the game. In battle mode women will perform aerobic activities, strength training and yoga exercises that involve the whole body to advance in the game. Women will receive in-game coin rewards, character customization and level progression based on exercise volume, which encourages improvement of their skills. As an example, with the assisted knee mode, women will have to squeeze and stretch the titular ring working muscles such as the trapezius, triceps, pectoralis major and minor and abdominal muscles. In addition, to go about defeating the monsters they will have to do shoulder abduction and adduction exercises, internal and external rotation of the shoulders and flexion of the elbow as shown in the images of the orientation trailer, provided to women and available in this memory.

@Control Group: Low-risk pregnant women who have normal pregnancy follow-up with Health Education received in childbirth preparation classes and maternal education received in routine pregnancy care by primary and specialized care midwives.

Masking: Unique (Results Evaluator).

Description of masking: Due to the design of the study and the nature of the interventions, it is impossible to mask staff and participants at the care centers. The evaluators, who measure the outcomes, and the interpreter, who analyzes the data, will be masked in this study.

Place: It will take place in a health center, which is part of the ecosystem of the Andalusian Health Service, having HD TV with HDMI connection to support the device, as well as good conditions of space, lighting and habitability that favor the comfort of the participating pregnant women. This will be detailed in the request for permission to the CEIH of the province of Jaén, requesting authorization from the center. 4. Recruitment and follow-up.

Women will be recruited at their first contact with pregnancy care and follow-up care, whether in primary or specialized care, through the midwives who provide this care in the aforementioned units. 5. Sources of information and target variables of the study.

In the first phase, women will be recruited who, after learning about the objectives of the project, voluntarily decide to participate. All of them will answer a self-administered questionnaire that will include sociodemographic variables, obstetric history and physical exercise before and during pregnancy, using the short version of the International Physical Activity Questionnaire (IPAQ) (IPAQ-SF), which quantifies physical activity during t