PregnancyNCT01696201
Effect of Physical Exercise Program on Outcomes and Level of Depression
A study testing Exercise group in people with Pregnancy, run by Technical University of Madrid at 1 site in Spain.
Trial summary
Due to physical and physiological changes that occur in pregnant women, depression is very common during this period. Recent research findings indicate that antenatal maternal mood state impacts on babies health. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Exercise group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2009to Jun 2015
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
- Being able to communicate in spanish
- Giving birth at Hospital Universitario de Fuenlabrada
Who cannot join
- Multiparity
- Obstetrician complications
- Being interested in the study after 18 weeks
- Not being regular in physical exercise program
- Younger than 18 years old
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universidad Politecnica de Madrid
Madrid, Madrid, 28040
Maria Perales, PhD student, 913364081, m.perales.santaella@gmail.com
About this study
Official title: Effect of a Supervised Exercise Program During Whole Pregnancy on Outcomes and Level of Depression. A Randomized Controlled Trial
Due to physical and physiological changes that occur in pregnant women, depression is very common during this period. Recent research findings indicate that antenatal maternal mood state impacts on babies health. Nowadays, many researchers are focussed on examining the effects of physical exercise on foetal and maternal outcomes.
The main aim of this study was to assess the effectiveness of a supervised exercise program consisted of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvis floor muscles training, on the prevention and treatment of depression in pregnant women. Additionally, the other purpose of the study was to analyze the effects of depression and physical exercise on outcomes.
Hypothesis: Pregnant women who do regular exercise during their pregnancies would have a better mood state than pregnant women who are sedentary, without having any negative effect on outcomes.
Read the detailed description
BACKROUND: Recent studies have estimated the prevalence of depression during pregnancy at between 10% and 30%. This state can produce negative effects on the fetus as:
- Affect cerebral development
- Increase the risk of preterm birth and low birth weight
- Increase the risk of childhood overweight problems
- Adverse impact on the cognitive, emotional, social, and behavioural development of infants
Due to the possible side effect of antidepressants on mother and fetus, its necessary to examine alternative solutions to this state.
- Conditions
- Pregnancy
- Being tested
- Exercise group
- Keywords
- Pregnancy, outcomes, depression, mood, physical exercise
- Medical subject headings
- Depression, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise groupBehavioural
Supervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (from week 9 to 38). Each session consists of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvic floor muscles training.
Aerobic activity was prescribed at light to moderate intensity, aiming for 55-60 of maximal heart rate. All subjects wore a heart rate (HR) monitor (Polar FT7) during the training sessions to ensure that exercise intensity was light to moderate.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Sedentary pregnant women |
| Exercise group | Experimental | Exercise program Receives: Behavioral: Exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from level of depression at the end of the pregnancy
The Center for Epidemiological Studies-Depression scale (CES-D) was administered to all pregnant women at the beginning and at the end of their pregnancies
Measured: Up to 36 weeks
Secondary outcomes (2)
Maternal outcome
Time of stages of labor (min)
Measured: Time spending in each stages of labor
Fetal outcome
Apgar score
Measured: 1-5 minutes after labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2012 (estimated)
- Study startOct 2009
- Primary completionMay 2013
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Perales Santaella, Technical University of Madrid
- Investigators
- Ruben Barakat, PhD, Study director, Universidad Politecnica de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01696201
- Sponsor's protocol ID
- Pregnancy outcomes
- Status last verified
- Sep 2012
- First submitted
- 17 Sep 2012
- Last updated
- 14 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.
PubMed 32378735
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Supervised Exercise Program During Whole Pregnancy on Outcomes and Level of Depression. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01696201
- Acronym / sponsor ID
- Pregnancy outcomes
- Conditions
- Pregnancy
- Keywords
- Pregnancy, outcomes, depression, mood, physical exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Technical University of MadridUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2015 (estimated)
- First posted
- 28 Sep 2012 (estimated)
- 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.
Due to physical and physiological changes that occur in pregnant women, depression is very common during this period. Recent research findings indicate that antenatal maternal mood state impacts on babies health. Nowadays, many researchers are focussed on examining the effects of physical exercise on foetal and maternal outcomes.
The main aim of this study was to assess the effectiveness of a supervised exercise program consisted of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvis floor muscles training, on the prevention and treatment of depression in pregnant women. Additionally, the other purpose of the study was to analyze the effects of depression and physical exercise on outcomes.
Hypothesis: Pregnant women who do regular exercise during their pregnancies would have a better mood state than pregnant women who are sedentary, without having any negative effect on outcomes.
Detailed description
BACKROUND: Recent studies have estimated the prevalence of depression during pregnancy at between 10% and 30%. This state can produce negative effects on the fetus as:
- Affect cerebral development
- Increase the risk of preterm birth and low birth weight
- Increase the risk of childhood overweight problems
- Adverse impact on the cognitive, emotional, social, and behavioural development of infants
Due to the possible side effect of antidepressants on mother and fetus, its necessary to examine alternative solutions to this state.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Sedentary pregnant women |
| Exercise group | Experimental | Behavioral: Exercise groupExercise program |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
- Being able to communicate in spanish
- Giving birth at Hospital Universitario de Fuenlabrada
Key exclusion criteria (5 listed)
- Multiparity
- Obstetrician complications
- Being interested in the study after 18 weeks
- Not being regular in physical exercise program
- Younger than 18 years old
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 |
|---|---|---|
| Exercise groupSupervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (from week 9 to 38). Each session consists of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvic floor muscles training. Aerobic activity was prescribed at light to moderate intensity, aiming for 55-60 of maximal heart rate. All subjects wore a heart rate (HR) monitor (Polar FT7) during the training sessions to ensure that exercise intensity was light to moderate. | Behavioural | Exercise group |
Primary outcome
Change from level of depression at the end of the pregnancy
Time frame: Up to 36 weeks
The Center for Epidemiological Studies-Depression scale (CES-D) was administered to all pregnant women at the beginning and at the end of their pregnancies
2 secondary outcomes
Maternal outcome
Time frame: Time spending in each stages of labor
Fetal outcome
Time frame: 1-5 minutes after labor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2014.
- Derived from this study: PubMed 32378735Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.
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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.
Ruben Barakat, PhD study director
Universidad Politecnica de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise group in people with Pregnancy, run by Technical University of Madrid 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 14 Nov 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Perales, PhD student (913364081, m.perales.santaella@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from level of depression at the end of the pregnancy (time frame: Up to 36 weeks). 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 NCT01696201, 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 14 Nov 2014; AzTrials last refreshed its copy on 27 Oct 2026.