NCT02761967

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 4, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

June 21, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2017

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

October 10, 2019

Completed
Last Updated

October 10, 2019

Status Verified

October 1, 2019

Enrollment Period

5 months

First QC Date

April 25, 2016

Results QC Date

April 30, 2018

Last Update Submit

October 9, 2019

Conditions

Keywords

Physical activityPregnancyChildbirthPostpartum periodExercise

Outcome Measures

Primary Outcomes (2)

  • 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 .

    Twenty four month

  • 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.

    Six month

Secondary Outcomes (1)

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

    Twelve month

Study Arms (2)

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.

Behavioral: Physical activity

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.

Interventions

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.

Physical activity

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Mixto Universitario Deporte y Salud

Granada, 18100, Spain

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Dr. Rodríguez-Blanque
Organization
University of Granada

Study Officials

  • MARIA JOSE AGUILAR CORDERO

    UNIVERSITY OF GRANADA (SPAIN)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

April 25, 2016

First Posted

May 4, 2016

Study Start

June 21, 2016

Primary Completion

November 12, 2016

Study Completion

January 15, 2017

Last Updated

October 10, 2019

Results First Posted

October 10, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations