PregnancyNCT02296060
Evaluation of Exercise Tolerance During Pregnancy
A study testing 6 minutes walking test in people with Pregnancy, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
To evaluate the exercise tolerance during pregnancy and after thanks the 6MWT Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- 6 minutes walking test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2014to Dec 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18-50 years old
- healthy women
Who cannot join
- BMI (before pregnancy) > 25
- complication with their pregnancy
Trial locations and contacts
1 site in 1 country.
Gregory Reychler, PhD contact
Belgium1 site
Cliniques Universitaires Saint-Luc
Brussels, Woluwé-Saint-Lambert, 1200
Gregory reychler, PhD
About this study
To evaluate the exercise tolerance during pregnancy and after thanks the 6MWT
- Conditions
- Pregnancy
- Being tested
- 6 minutes walking test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 minutes walking testProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 6 minutes walking test | Experimental | Not described Receives: Procedure: 6 minutes walking test |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minutes walking test
Measured: after 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2015 (estimated)
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.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02296060
- Sponsor's protocol ID
- 6MWT pregnancy
- Status last verified
- Nov 2014
- First submitted
- 18 Nov 2014
- Last updated
- 20 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Exercise Tolerance During Pregnancy
- ClinicalTrials.gov ID
- NCT02296060
- Acronym / sponsor ID
- 6MWT pregnancy
- Conditions
- Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (estimated)
- First posted
- 20 Nov 2014 (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.
To evaluate the exercise tolerance during pregnancy and after thanks the 6MWT
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 6 minutes walking test | Experimental | Procedure: 6 minutes walking test |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18-50 years old
- healthy women
Key exclusion criteria (2 listed)
- BMI (before pregnancy) > 25
- complication with their 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 |
|---|---|---|
| 6 minutes walking test | Procedure or surgery | 6 minutes walking test |
Primary outcome
6 minutes walking test
Time frame: after 6 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2014.
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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.
Gregory Reychler, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6 minutes walking test in people with Pregnancy, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 2 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: status not confirmed, as of the sponsor's last update on 20 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 Belgium. 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 Gregory Reychler, PhD (gregory.reychler@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 minutes walking test (time frame: after 6 minutes). 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 20 Nov 2014.