Clinical trial NCT02761967: Physical Activity in Pregnancy and Postpartum Period, Effects on Women
Official title: Physical Training in Water (SWEP Method) During Pregnancy and Low Pressure Fitness (LPF) in Postpartum Period, Effects on Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: Physical activity
Pregnancy
Childbirth
Postpartum period
Exercise
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2016-05-04
Enrollment: 140
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Delivery Times Measured in Partogram
timeFrame: Twenty four month
measure: Edinburgh Postnatal Depression Scale
timeFrame: Six month
Secondary outcomes:
measure: Sleep Quality in Pregnant; Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Twelve month
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Instituto Mixto Universitario Deporte y Salud
Study officials:
affiliation: UNIVERSITY OF GRANADA (SPAIN)
name: MARIA JOSE AGUILAR CORDERO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aguilar-Cordero MJ, Sanchez-Garcia JC, Rodriguez-Blanque R, Sanchez-Lopez AM, Mur-Villar N. Moderate Physical Activity in an Aquatic Environment During Pregnancy (SWEP Study) and Its Influence in Preventing Postpartum Depression. J Am Psychiatr Nurses Assoc. 2019 Mar/Apr;25(2):112-121. doi: 10.1177/1078390317753675. Epub 2018 Feb 28.