Skip to content

Physical Activity in Pregnancy and Postpartum Period, Effects on Women

Physical Training in Water (SWEP Method) During Pregnancy and Low Pressure Fitness (LPF) in Postpartum Period, Effects on Women

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02761967
Enrollment
140
Registered
2016-05-04
Start date
2016-06-21
Completion date
2017-01-15
Last updated
2019-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

Physical activity, Pregnancy, Childbirth, Postpartum period, Exercise

Brief summary

This study evaluates whether the use of moderate physical exercise character in water is beneficial for pregnant women. Half of the participants will carry out moderate physical exercise character in water, following the protocol developed specifically for this purpose and called SWEP (Study Water Exercises Program) method, while the other group will not perform physical exercise during pregnancy. Concluded the postpartum period, women perform exercises aimed postpartum recovery. The women's group has conducted exercises during pregnancy postpartum recovery made under the guidance of LPF (Low Pressure Fitness) method.

Detailed description

Preliminary phase: Current status of the subject. During this phase will be an updated systematic search research topic. The literature search in databases such as MEDLINE, SCOPUS, CINAHL, WoS (Web Of Science) among others. Data Collection: The source for the collection of primary data is through a personal interview with the participants and through the primer health of pregnant and/or medical history. Interview on the first visit: * Collect socioeconomic and health data about participants: age, parity, weight, BMI, smoking habits, drug use, profession/occupation, education level, physical activity pattern prior to pregnancy. * Degree of overall health perception. * Assess the risks according to the guide of the American College of Obstetricians and Gynecologists. * Obtaining informed when agreeing to participate in the study consent. * Give information pack about the exercises that the investigators will perform well as controls to be made in each session, and general rules to practice any physical activity. Execution: Classes are held in the morning hours preferable between 10 and 11 o'clock in the morning after a caloric intake and adequate hydration. Every participant should carry your water bottle during each session that will take place, as well as adequate clothing, in which bathing suit, hat, glasses and proper footwear is included to prevent falls. Before each class dynamics to follow and the signs that will make the exercise should stop, every participant should know how to take her own pulse at the level of the carotid artery may recall, because at different times of the central activity will take frequency heart, as a general rule must be able to hold a conversation without much difficulty while performing the exercise, and during the performance of this should properly hydrated according to the needs of each one in particular. 1. Warm up: The warm-up exercise will take place in a small vessel, where the water depth is around the thighs. The session starts with the upper body and decreasing order to heat the lower body. 2. Central part of the activity. It is be held in the large vessel, exercise intensity will increase in order to keep within the limits for an exercise of moderate, use different devices support to carry it out and exercises of strength, endurance and pelvic elasticity are included. Assistive devices that will use floating elements that will help us reduce the intensity of exercise providing flotation and will serve as support material to work specific parts. These devices are floating tables expanded polystyrene foam boys pull soft polyethylene and flexible floating bars and playful elements, such as balls, rings, ... spades. 3. Phase cool down. In this phase the participants will seek to return to calm, will be done in the small vessel having 3-4 ° C more than the large glass. exercises to progressively reducing the intensity and ending with relaxation exercises will be conducted . The exercises are flexibility the investigators will not keep avoiding positions that strain the joints due to the state of gestation, those areas that have been previously exercised not to exceed the natural movement will stretch. Once found befallen birth one review and extraction of data on birth process will take place and will take a final interview with the participant to collect data that will be obtained during the postpartum period such as type of feed received by the newborn, and value the existence of postpartum depression with the Edinburgh test. Concluded the postpartum period. Women begin a program of recovery postpartum 12 weeks, 3 times a week in sessions of one hour. They perform warm-up exercises, a central part of Low Pressure Fitness exercises and end with stretching exercises.

Interventions

BEHAVIORALPhysical activity

Women from the 20th week of moderate physical exercise performed in water character designed following the guidelines in the SWEP method will end in week 37 of gestation. After the postpartum period, women begin a program based on postpartum recovery exercises Fitness Low Pressure method 12-week, 3 days a week, in sessions of 60 minutes.

Sponsors

Juan Carlos Sanchez Garcia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

Inclusion criteria

* Do not suffer any absolute contraindications according to the American College of Obstetricians and Gynecologists. * If there is a relative contraindication, participation in the intervention group should be favorable report by participants obstetrician. * To know how to swim. * To sign informed consent to participate in research consent.

Exclusion criteria

* Absolute contraindications to aerobic exercise during pregnancy. * Restrictive lung disease. * Heart disease with hemodynamic consequences. * Incompetent cervix/cerclage. * Multiple gestation with preterm labor. * Persistent bleeding in the second or third trimester bleeding. * Previa after 26 weeks of gestation. * Preterm birth during the current pregnancy. * Rupture of membranes. * Pregnancy-induced hypertension. * Relative contraindications to aerobic exercise during pregnancy. * Severe anemia. * Cardiac arrhythmia maternal unevaluated. * Chronic Bronchitis. * Type I diabetes poorly controlled. * Extreme morbid obesity. * Under extreme weight (BMI \<12). * History of extremely sedentary life style. * Intrauterine growth restriction in current pregnancy. * Poorly controlled hypertension / pre-eclampsia. * Orthopedic limitations. * Poorly controlled seizure disorders. * Poorly controlled Thyroid disease. * Heavy smoker.

Design outcomes

Primary

MeasureTime frameDescription
Delivery Times Measured in PartogramTwenty four monthThis result is to measure the difference in time between births to women who have made physical exercise during pregnancy, SWEP method, compared to women who have not exercised .
Edinburgh Postnatal Depression ScaleSix monthDetermine the rate of postpartum depression in both groups. The scale consists of ten short questions, all of which must be answered. The subject is asked to choose, of the four possible answers, the one that most closely describes how she felt during the week prior to the test. The response options range from 0 (for example, no, not at all or no, never again) to 3 (for example, yes, most of the time or yes, very often). The total score is recorded in a table ranging from 0 to 30, where higher values indicate more severe symptoms of depression. For this study, total scores below 10 were classed as no risk and scores of 10 or more indicated the presence of risk. Scores above 16 indicated a more severe risk of depression, and suggested that additional evaluations should be conducted immediately.

Secondary

MeasureTime frameDescription
Sleep Quality in Pregnant; Pittsburgh Sleep Quality Index (PSQI)Twelve monthAssess the quality of sleep of pregnant women with moderate activity in water, with respect to who do not practice. Consisting of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.The order of the PSQI items has been modified from the original order in order to fit the first 9 items (which are the only items that contribute to the total score) on a single page. Item 10, which is the second page of the scale, does not contribute to the PSQI score. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.

Countries

Spain

Participant flow

Participants by arm

ArmCount
Physical Activity
The woman he joins the intervention group meets once a week 20 of gestation and ends after serving 37 weeks. Intervention will consist of physical exercise of moderate character in water, according to the methodology of the method of SWEP, for an hour a day, three days a week. After the postpartum period, women begin a program based on postpartum recovery exercises Fitness Low Pressure method 12-week, 3 days a week, in sessions of 60 minutes. Physical activity: Women from the 20th week of moderate physical exercise performed in water character designed following the guidelines in the SWEP method will end in week 37 of gestation. After the postpartum period, women begin a program based on postpartum recovery exercises Fitness Low Pressure method 12-week, 3 days a week, in sessions of 60 minutes.
70
No Exercise
Not take place during the gestation period between gestation week 20 to 37 any physical exercise. Not take place during the postpartum period any physical exercise.
70
Total140

Baseline characteristics

CharacteristicPhysical ActivityNo ExerciseTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
70 Participants70 Participants140 Participants
Age, Continuous34.74 years
STANDARD_DEVIATION 4.41
33.47 years
STANDARD_DEVIATION 5.18
34.1 years
STANDARD_DEVIATION 4.7
BMI24.7 kg/m^2
STANDARD_DEVIATION 4.16
24.93 kg/m^2
STANDARD_DEVIATION 4.8
24.81 kg/m^2
STANDARD_DEVIATION 4.4
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
Spain
70 Participants70 Participants140 Participants
Sex: Female, Male
Female
70 Participants70 Participants140 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 700 / 70
other
Total, other adverse events
0 / 700 / 70
serious
Total, serious adverse events
0 / 700 / 70

Outcome results

Primary

Delivery Times Measured in Partogram

This result is to measure the difference in time between births to women who have made physical exercise during pregnancy, SWEP method, compared to women who have not exercised .

Time frame: Twenty four month

Population: The total duration of delivery times between women in the control group and women in the exercise group will be compared.

ArmMeasureValue (MEAN)Dispersion
Physical ActivityDelivery Times Measured in Partogram389.33 minutesStandard Deviation 216.18
No ExerciseDelivery Times Measured in Partogram561.3 minutesStandard Deviation 199.94
p-value: 0.776Chi-squared
Primary

Edinburgh Postnatal Depression Scale

Determine the rate of postpartum depression in both groups. The scale consists of ten short questions, all of which must be answered. The subject is asked to choose, of the four possible answers, the one that most closely describes how she felt during the week prior to the test. The response options range from 0 (for example, no, not at all or no, never again) to 3 (for example, yes, most of the time or yes, very often). The total score is recorded in a table ranging from 0 to 30, where higher values indicate more severe symptoms of depression. For this study, total scores below 10 were classed as no risk and scores of 10 or more indicated the presence of risk. Scores above 16 indicated a more severe risk of depression, and suggested that additional evaluations should be conducted immediately.

Time frame: Six month

ArmMeasureValue (MEAN)Dispersion
Physical ActivityEdinburgh Postnatal Depression Scale6 units on a scaleStandard Deviation 3.39
No ExerciseEdinburgh Postnatal Depression Scale8 units on a scaleStandard Deviation 2.33
Secondary

Sleep Quality in Pregnant; Pittsburgh Sleep Quality Index (PSQI)

Assess the quality of sleep of pregnant women with moderate activity in water, with respect to who do not practice. Consisting of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.The order of the PSQI items has been modified from the original order in order to fit the first 9 items (which are the only items that contribute to the total score) on a single page. Item 10, which is the second page of the scale, does not contribute to the PSQI score. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.

Time frame: Twelve month

Population: During the data collection, 3 women from the control group were lost because they did not complete the PSQI questionnaire during the follow-up phase. The analysis excluded 3 women from the intervention group due to errors at the time of completing the PSQI questionnaire.

ArmMeasureValue (MEAN)Dispersion
Physical ActivitySleep Quality in Pregnant; Pittsburgh Sleep Quality Index (PSQI)6.84 units on a scaleStandard Deviation 2.86
No ExerciseSleep Quality in Pregnant; Pittsburgh Sleep Quality Index (PSQI)10.10 units on a scaleStandard Deviation 3.12

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026