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临床试验/NCT02761967
NCT02761967已完成不适用

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

Juan Carlos Sanchez Garcia2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2016年6月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
140
试验地点
2
主要终点
Delivery Times Measured in Partogram

研究概览

简要总结

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.

详细描述

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:

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
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Physical activity

Experimental

The women in the EG (Exercise Group) performed moderate physical exercise in water, following the SWEP method (Study of Water-based Exercise during Pregnancy). It consists of performing moderate physical exercise in an aquatic environment from weeks 20 to 37 of gestation. The sessions take place three times weekly, with a duration of 60 minutes each (45 minutes of activity followed by 15 minutes of relaxation). The sessions are composed of three phases: a) warm-up; b) the main phase, divided into aerobic exercise and strength-endurance exercises, designed specifically for pregnant women; c) stretching and relaxation.

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.

干预措施: Physical activity (Behavioral)

No exercise

No Intervention

The CG (Control Group) received the standard recommendations during pregnancy, including guidelines from the midwife on the positive effects of physical exercise. These participants received the usual visits from healthcare providers (midwives, obstetricians and family doctor) during pregnancy, as did those in the EG.

After the postpartum period, the women in the control group did not perform regulated physical activity.

结局指标

主要结局

Delivery Times Measured in Partogram

时间窗: Twenty four month

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 .

Edinburgh Postnatal Depression Scale

时间窗: Six month

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.

次要结局

  • Sleep Quality in Pregnant; Pittsburgh Sleep Quality Index (PSQI)(Twelve month)

研究者

发起方
Juan Carlos Sanchez Garcia
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Juan Carlos Sanchez Garcia

PhD

Universidad de Granada

研究点 (2)

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