PregnancyNCT02761967
Physical Activity in Pregnancy and Postpartum Period, Effects on Women
A study testing Physical activity in people with Pregnancy, run by Juan Carlos Sanchez Garcia at 1 site in Spain.
Trial 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)… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSpain
- Study dates
- 21 Jun 2016to 15 Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 24Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Training in Water (SWEP Method) During Pregnancy and Low Pressure Fitness (LPF) in Postpartum Period, Effects on Women
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.
Read the 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.
- 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.
- 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.
- 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.
- Conditions
- Pregnancy
- Being tested
- Physical activity
- Keywords
- Physical activity, Pregnancy, Childbirth, Postpartum period, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 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.
Measured: Six month
Secondary outcomes (1)
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.
Measured: Twelve month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study start21 Jun 2016
- Primary completion12 Nov 2016
- Study completion15 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juan Carlos Sanchez Garcia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Juan Carlos Sanchez Garcia, Universidad de Granada
- Investigators
- MARIA JOSE AGUILAR CORDERO, Principal investigator, UNIVERSITY OF GRANADA (SPAIN)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02761967
- Sponsor's protocol ID
- 20022014UGR
- Status last verified
- Oct 2019
- First submitted
- 25 Apr 2016
- Last updated
- 10 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29490560
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Training in Water (SWEP Method) During Pregnancy and Low Pressure Fitness (LPF) in Postpartum Period, Effects on Women
- ClinicalTrials.gov ID
- NCT02761967
- Acronym / sponsor ID
- 20022014UGR
- Conditions
- Pregnancy
- Keywords
- Physical activity, Pregnancy, Childbirth, Postpartum period, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Juan Carlos Sanchez GarciaUniversity, hospital or other
- Study start
- 21 Jun 2016 (actual)
- Primary completion
- 12 Nov 2016 (actual)
- Study completion
- 15 Jan 2017 (actual)
- First posted
- 4 May 2016 (estimated)
- Results
- Posted 10 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity | Experimental | Behavioral: Physical activityThe 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. |
| 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (24 listed)
- Absolute contraindications to aerobic exercise during pregnancy.
- Relative contraindications to aerobic exercise during pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activityWomen 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. | Behavioural | Physical activity |
Primary outcome
Delivery Times Measured in Partogram
Time frame: 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
Time frame: 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.
1 secondary outcome
Sleep Quality in Pregnant; Pittsburgh Sleep Quality Index (PSQI)
Time frame: Twelve month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29490560Aguilar-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MARIA JOSE AGUILAR CORDERO principal investigator
UNIVERSITY OF GRANADA (SPAIN)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Pregnancy, run by Juan Carlos Sanchez Garcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delivery Times Measured in Partogram (time frame: Twenty four month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02761967, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2019.