PregnancyNCT04619394
Analysis of the Effectiveness of Aquatic Exercise on the Static and Dynamic Balance in Pregnant Women
A study testing Aquatic exercise - own monitors program and Aquatic exercise - AIPAP program in people with Pregnancy and Aquatic Physical Exercise, run by José M. Cancela at 1 site in Spain.
Trial summary
Research about the balance in pregnant women who perform water exercise and those who do not engage in any type of sporting activity. The initial objectives are to know if there is an improvement in the balance in women who perform aquatic exercise reviewed at the end of pregnancy versus those who do not, through the… Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Aquatic Physical Exercise, Balance
- What is being tested?
- Aquatic exercise - own monitors program and Aquatic exercise - AIPAP program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2017to 22 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The criteria for inclusion of the sample are: 1. Women aged between 20 and 35 years since before 20 years and after 35 years it is associated with a greater maternal and perinatal risk.2. The intensity of the physical workload must be moderate to very light . 3. The gestational age (EG) in which they are captured must be delimited between 10 and 12 weeks of gestation (SG) without any obstetric risk or associated pathology, primiparous or multiparous.
Who cannot join
- Exclusion and withdrawal criteria. The exclusion criteria will be: 1. Present any type of absolute / relative obstetric contraindication. 2. Not to have notions of swimming. 3. Multiple pregnancies. 4. Pregnant women with cognitive / physical disability. 5. Present some diagnosed pathology that alters the normal balance as neurological, traumatological or podiatric diseases.
- The appearance of any warning signs / symptoms such as vaginal bleeding, feeling light-headed or faint, difficulty breathing before doing exercise, chest pain, headache, muscle weakness, pain or swelling in the calves, Regular and painful contractions in the uterus and drip of fluid through the vagina, will imply the abandonment of the physical exercise program that was developing.
Trial locations and contacts
1 site in 1 country.
About this study
Research about the balance in pregnant women who perform water exercise and those who do not engage in any type of sporting activity. The initial objectives are to know if there is an improvement in the balance in women who perform aquatic exercise reviewed at the end of pregnancy versus those who do not, through the use of a podiatric platform. This experimental randomized controlled study (RCT) will be carried out in sports centers and / or public or private municipal swimming pools in the south of Galicia The recruitment of passive pregnant women (control group) will be carried out in the health center of Pontevedra Virxe da Peregrina in the first visit to the midwife in the 10th and 12th week of gestation, while the recruitment of the active pregnant women (group experimental 1 and experimental group 2) in the teaching centers of the aquatic exercise sessions in the same weeks of gestation. The women of the three groups will have a low-risk normoevolutive pregnancy and will be studied in the first and third trimesters. The instruments that will be used to obtain data will be through an initial questionnaire, a platform and study of stability through the center of gravity and base of podiatric support. The plan for analyzing the data will be done through SPSS 17.0.
- Conditions
- Pregnancy, Aquatic Physical Exercise, Balance
- Being tested
- Aquatic exercise - own monitors program, Aquatic exercise - AIPAP program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquatic exercise - own monitors programOther
Supervision of own exercises by the Monitor with its own program. Two weekly sessions, both aquatic in small glass and large. The activity carried out will be aerobic; They will work with their own body weight and the lightweight floating material they offer in these pools. Exercises will be carried out that favor flexibility, elasticity, resistance and the strengthening of the muscular ligaments. The intensity of the exercises will be moderate and adapted in each month of gestation. We will eliminate positions and exercises that overload the pregnant woman, avoiding possible injuries and obstetric alterations.
The start of the program will be established in week 10-12 of the pregnancy and the end in week 37-41.
The total number of sessions of the program will be from 25 to 31 (28 sessions of minimum compliance), with a frequency of 2 sessions per week. The duration of these will be 50 minutes and adherence to both experimental groups of ≥28 classes.
Aquatic exercise - AIPAP programOther
Supervised by a midwife with AIPAP method. AIPAP method is divided into 10 sessions of 50 minutes that are repeated cyclically with a total of 120 exercises. The sessions are divided into 5 groups with different objectives: 2 sessions of aerobic capacity improvement, 2 sessions of strength improvement, 2 sessions of pelvic elasticity, 2 coordination sessions and the last 4 sessions of the previous ones.
The beginning of the program will be established in week 10-12 of pregnancy and the end in week 37-41.
The total number of sessions of the program will be 25-31 (28 sessions of minimum compliance), with a frequency of 2 sessions per week. The duration of these will be 50 minutes in both experimental groups. It will be necessary to obtain an adherence to both experimental groups of ≥28 classes.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (CG) | No intervention | Control Group (CG): Formed by those pregnant women who do not perform any physical exercise, only the basic and instrumental activities of daily life (ABVD and AIVD respectively) and intensity of the physical labor load of very light to moderate. The period from 10-12 SG to 37-41 SG. |
| Experimental Group 1 (GE1) | Active comparator | Experimental Group 1 (GE1): Created for pregnant women who carry out their own program of each monitor in the different sports centers and public and private swimming pools in the South of the Autonomous Community of Galicia. These own programs will all have the same format: initial warm-up phase, main part of indicated and personalized exercises for pregnancies and final phase with a return to calm. Receives: Other: Aquatic exercise - own monitors program |
| Experimental Group 2 (GE2) | Active comparator | Experimental Group 2 (GE2): In this third and last group, we incorporated the AIPAP program into the exclusive programs of each monitor in the various public and private sports centers and swimming pools in the South of the Autonomous Community of Galicia. The researcher trained in this method, together with the monitors who voluntarily wish to do so, will translate said format and program into their sessions. Receives: Other: Aquatic exercise - AIPAP program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
Balance analysis by force platform
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start1 Oct 2017
- Primary completion3 Apr 2018
- Study completion22 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- José M. Cancela
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, José M. Cancela, University of Vigo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619394
- Sponsor's protocol ID
- EACE01
- Status last verified
- Nov 2020
- First submitted
- 2 Nov 2020
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Effectiveness of Aquatic Exercise on the Static and Dynamic Balance in Pregnant Women
- ClinicalTrials.gov ID
- NCT04619394
- Acronym / sponsor ID
- EACE01
- Conditions
- Pregnancy, Aquatic Physical Exercise, Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- José M. CancelaUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 3 Apr 2018 (actual)
- Study completion
- 22 Apr 2020 (actual)
- First posted
- 6 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research about the balance in pregnant women who perform water exercise and those who do not engage in any type of sporting activity. The initial objectives are to know if there is an improvement in the balance in women who perform aquatic exercise reviewed at the end of pregnancy versus those who do not, through the use of a podiatric platform. This experimental randomized controlled study (RCT) will be carried out in sports centers and / or public or private municipal swimming pools in the south of Galicia The recruitment of passive pregnant women (control group) will be carried out in the health center of Pontevedra Virxe da Peregrina in the first visit to the midwife in the 10th and 12th week of gestation, while the recruitment of the active pregnant women (group experimental 1 and experimental group 2) in the teaching centers of the aquatic exercise sessions in the same weeks of gestation. The women of the three groups will have a low-risk normoevolutive pregnancy and will be studied in the first and third trimesters. The instruments that will be used to obtain data will be through an initial questionnaire, a platform and study of stability through the center of gravity and base of podiatric support. The plan for analyzing the data will be done through SPSS 17.0.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group (CG) | No intervention | –Control Group (CG): Formed by those pregnant women who do not perform any physical exercise, only the basic and instrumental activities of daily life (ABVD and AIVD respectively) and intensity of the physical labor load of very light to moderate. The period from 10-12 SG to 37-41 SG. |
| Experimental Group 1 (GE1) | Active comparator | Other: Aquatic exercise - own monitors programExperimental Group 1 (GE1): Created for pregnant women who carry out their own program of each monitor in the different sports centers and public and private swimming pools in the South of the Autonomous Community of Galicia. These own programs will all have the same format: initial warm-up phase, main part of indicated and personalized exercises for pregnancies and final phase with a return to calm. |
| Experimental Group 2 (GE2) | Active comparator | Other: Aquatic exercise - AIPAP programExperimental Group 2 (GE2): In this third and last group, we incorporated the AIPAP program into the exclusive programs of each monitor in the various public and private sports centers and swimming pools in the South of the Autonomous Community of Galicia. The researcher trained in this method, together with the monitors who voluntarily wish to do so, will translate said format and program into their sessions. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The criteria for inclusion of the sample are: 1. Women aged between 20 and 35 years since before 20 years and after 35 years it is associated with a greater maternal and perinatal risk.2. The intensity of the physical workload must be moderate to very light . 3. The gestational age (EG) in which they are captured must be delimited between 10 and 12 weeks of gestation (SG) without any obstetric risk or associated pathology, primiparous or multiparous.
Key exclusion criteria (2 listed)
- Exclusion and withdrawal criteria. The exclusion criteria will be: 1. Present any type of absolute / relative obstetric contraindication. 2. Not to have notions of swimming. 3. Multiple pregnancies. 4. Pregnant women with cognitive / physical disability. 5. Present some diagnosed pathology that alters the normal balance as neurological, traumatological or podiatric diseases.
- The appearance of any warning signs / symptoms such as vaginal bleeding, feeling light-headed or faint, difficulty breathing before doing exercise, chest pain, headache, muscle weakness, pain or swelling in the calves, Regular and painful contractions in the uterus and drip of fluid through the vagina, will imply the abandonment of the physical exercise program that was developing.
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 |
|---|---|---|
| Aquatic exercise - own monitors programSupervision of own exercises by the Monitor with its own program. Two weekly sessions, both aquatic in small glass and large. The activity carried out will be aerobic; They will work with their own body weight and the lightweight floating material they offer in these pools. Exercises will be carried out that favor flexibility, elasticity, resistance and the strengthening of the muscular ligaments. The intensity of the exercises will be moderate and adapted in each month of gestation. We will eliminate positions and exercises that overload the pregnant woman, avoiding possible injuries and obstetric alterations. The start of the program will be established in week 10-12 of the pregnancy and the end in week 37-41. The total number of sessions of the program will be from 25 to 31 (28 sessions of minimum compliance), with a frequency of 2 sessions per week. The duration of these will be 50 minutes and adherence to both experimental groups of ≥28 classes. | Other | Experimental Group 1 (GE1) |
| Aquatic exercise - AIPAP programSupervised by a midwife with AIPAP method. AIPAP method is divided into 10 sessions of 50 minutes that are repeated cyclically with a total of 120 exercises. The sessions are divided into 5 groups with different objectives: 2 sessions of aerobic capacity improvement, 2 sessions of strength improvement, 2 sessions of pelvic elasticity, 2 coordination sessions and the last 4 sessions of the previous ones. The beginning of the program will be established in week 10-12 of pregnancy and the end in week 37-41. The total number of sessions of the program will be 25-31 (28 sessions of minimum compliance), with a frequency of 2 sessions per week. The duration of these will be 50 minutes in both experimental groups. It will be necessary to obtain an adherence to both experimental groups of ≥28 classes. | Other | Experimental Group 2 (GE2) |
Primary outcome
Balance
Time frame: 24 weeks
Balance analysis by force platform
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquatic exercise - own monitors program and Aquatic exercise - AIPAP program in people with Pregnancy and Aquatic Physical Exercise, run by José M. Cancela 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 1 inclusion and 2 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 6 Nov 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Balance (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2020.