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

NCT07041970 | Not Yet Recruiting

• 1 other identifier: PregFit-Jun-25
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

• 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 (Romero-Gallardo et al., 2020), 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 (Tuan et al., 2024) 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.
• 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.

Conditions

Pregnant Women; Exercise; Game

Keywords

pregnant women; exercise; physical condition; exergames; low-risk pregnancy; physical activity

Outcome Measures

Primary Outcomes (2)

• Increase in the level of habitual physical activity - Short version of the International Physical Activity Questionnaire (IPAQ-SF)

  Short version of the International Physical Activity Questionnaire (IPAQ) (IPAQ-SF), which quantifies physical activity during the last seven days, divided into four categories: vigorous intensity, moderate intensity, walking and sitting. In addition to intensity, the frequency and duration of physical activity are assessed. It includes 7 items on the "last 7 days" with items such as "During the last 7 days, how many days did you perform vigorous physical activities such as heavy lifting, digging, aerobic exercise, running or cycling at high speed?", with responses from 0 to 7. The response categories are divided into "don't know", "10 min", "20 min", and so on up to "2 h or more". The tool is validated in pregnant women which allows assessing the level of physical activity in this population, including the frequency, duration and intensity of the activity performed.

  From 8 weeks to 3 months

• Significant improvements in physical condition parameters - International Fitness Scale-IFIS

  The International Fitness Scale-IFIS, previously validated in the Spanish pregnant population. It is an assessment tool designed to measure adults' perception of their general fitness status. It was developed in order to provide a simple and quick way to obtain information on different dimensions of physical fitness, without the need for complex physical tests, assessing: Aerobic capacity or cardiovascular endurance, muscular strength, muscular endurance, flexibility, speed and agility. The answers are given on a Likert scale of 5 options: Very bad, Bad, Acceptable, Good and Very good. The higher the score, the better the self-perception of general physical fitness. It has been adapted to different populations and sociocultural contexts.

  From 8 weeks to 3 months.

Study Arms (2)

Intervention

EXPERIMENTAL

@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.

Other: Exergame

Control

NO INTERVENTION

@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.

Interventions

Exergame OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women (cis).
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Jaén: lead

MeSH Terms

Conditions

Motor Activity

Interventions

Exergaming

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

SERGIO S MARTÍNEZ VÁZQUEZ, DOCTOR IN HEALTH SCIENCES

CONTACT

0034 953 21 20 14; svazquez@ujaen.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: * 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. * 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.

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: June 27, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 26, 2026
• Study Completion (Estimated): December 26, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-06