PainNCT02301559
The Influence of the Method Pilates in Women With Primary Dysmenorrhea
A study testing Pilates exercises in people with Pain, run by Universidade Estadual do PiauÍ at 1 site in Brazil.
Trial summary
Primary dysmenorrhea is the result of hypercontractility and uterine vascular ischemia is the most common gynecologic complaints in young women. According to the intensity of symptoms may impair daily living, work and leisure activities. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Pilates exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2014to Dec 2014
- 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 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntary
- Female
- 18-25 years old
- Enrolled in Physiotherapy course at the State University of Piauí- UESPI, with symptoms compatible with primary, nulliparous dysmenorrhoea, who have regular menstrual cycle and who agree to participate spontaneously in the research, by signing a term of informed consent (Appendix a) in accordance with Resolution 466/2012.
- Participation in the survey did not veto the use of analgesic or contraceptive by the participants.
- All are oriented to maintaining the habits of life - food, work and leisure activities, medications - during the exercises
Who cannot join
- Will not be included in the selected research volunteers that do not show symptoms and characteristics consistent with primary dysmenorrhoea according to the questionnaire, and those who accept not participate and / or not signing the consent form sample.
- As criteria for inclusion are also not chronic back pain, regular physical activity (3 or more times per week), women with pathological picture associated or malformation of the pelvic organs (secondary dysmenorrhea), or those that make use of device Intra- uterus (IUD).
- Will be excluded from the sample participants who submit two consecutive absences to care.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Estadual do Piaui
Teresina, Piauí, 64000000
Juliany M A da Fonseca, Principal, (86)81644967, juliany.markes@hotmail.com
About this study
Official title: The Influence of the Method Pilates in Life Quality, Intensity of Pain and Flexibility of Women With Primary Dysmenorrhea
Primary dysmenorrhea is the result of hypercontractility and uterine vascular ischemia is the most common gynecologic complaints in young women. According to the intensity of symptoms may impair daily living, work and leisure activities. Pilates brings the concept of moving the body for the recovery, maintenance and promotion of health through exercises that stimulate circulation, improving physical conditioning, flexibility and proper postural alignment, and promote improvement in the levels of body awareness, coordination and muscle control. In this sense, the objective is to investigate the effects of pilates in the symptomatology of primary dysmenorrhea. This is a study to be developed with students of Physical Therapy from the State University of Piauí-UESPI presenting with primary dysmenorrhea compatible clinical picture. A questionnaire will be used for research. The students with the framework of dysmenorrhea that meet the inclusion criteria will be assessed for anthropometric parameters, pain, flexibility, indirect assessment of contraction of transversus abdominis and quality of life before and after the treatment protocol using the pilates method, often 3 weekly meetings, totaling 20 sessions.
Read the detailed description
The objective is to investigate the effects of pilates in the symptomatology of primary dysmenorrhea. This is a study to be developed with students of Physical Therapy from the State University of Piauí-UESPI presenting with primary dysmenorrhea compatible clinical picture. A questionnaire will be used for research. The students with the framework of dysmenorrhea that meet the inclusion criteria will be assessed for anthropometric parameters, pain, flexibility, indirect assessment of contraction of transversus abdominis and quality of life before and after the treatment protocol using the pilates method, often 3 weekly meetings, totaling 20 sessions.
- Conditions
- Pain
- Being tested
- Pilates exercises
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates exercisesBehavioural
Pilates exercises with emphasis on pelvic region
| Study group | Role | What they receive |
|---|---|---|
| Pilates Group | Experimental | Pilates Group, Pilates exercises, 20 sessions, lasting 40 minutes each, 3 times per week. Soil and ball exercises, with emphasis on the pelvic region. The program began with the work of breathing and postural correction, with warm-up exercises or preparatory, followed by the framework of classical movements of the method. Receives: Behavioral: Pilates exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain, Visual analog scale
Effects of pilates method in pain
Measured: two months
Quality of health, score Short Form-36
Effects of pilates method in quality of health
Measured: two months
Secondary outcomes (1)
Flexibility, finger-ground test
Effects of pilates method in flexibility
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2014 (estimated)
- Study startSep 2014
- Primary completionNov 2014
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual do PiauÍ
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juliany Marques Abreu da Fonseca, Universidade Estadual do PiauÍ
- Investigators
- Juliany M A da Fonseca, Principal, Principal investigator, Universidade Estadual do PiauÍ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301559
- Sponsor's protocol ID
- 04008402357J
- Status last verified
- Nov 2014
- First submitted
- 16 Nov 2014
- Last updated
- 26 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of the Method Pilates in Life Quality, Intensity of Pain and Flexibility of Women With Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT02301559
- Acronym / sponsor ID
- 04008402357J
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- Universidade Estadual do PiauÍUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (estimated)
- First posted
- 26 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.
Primary dysmenorrhea is the result of hypercontractility and uterine vascular ischemia is the most common gynecologic complaints in young women. According to the intensity of symptoms may impair daily living, work and leisure activities. Pilates brings the concept of moving the body for the recovery, maintenance and promotion of health through exercises that stimulate circulation, improving physical conditioning, flexibility and proper postural alignment, and promote improvement in the levels of body awareness, coordination and muscle control. In this sense, the objective is to investigate the effects of pilates in the symptomatology of primary dysmenorrhea. This is a study to be developed with students of Physical Therapy from the State University of Piauí-UESPI presenting with primary dysmenorrhea compatible clinical picture. A questionnaire will be used for research. The students with the framework of dysmenorrhea that meet the inclusion criteria will be assessed for anthropometric parameters, pain, flexibility, indirect assessment of contraction of transversus abdominis and quality of life before and after the treatment protocol using the pilates method, often 3 weekly meetings, totaling 20 sessions.
Detailed description
The objective is to investigate the effects of pilates in the symptomatology of primary dysmenorrhea. This is a study to be developed with students of Physical Therapy from the State University of Piauí-UESPI presenting with primary dysmenorrhea compatible clinical picture. A questionnaire will be used for research. The students with the framework of dysmenorrhea that meet the inclusion criteria will be assessed for anthropometric parameters, pain, flexibility, indirect assessment of contraction of transversus abdominis and quality of life before and after the treatment protocol using the pilates method, often 3 weekly meetings, totaling 20 sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilates Group | Experimental | Behavioral: Pilates exercisesPilates Group, Pilates exercises, 20 sessions, lasting 40 minutes each, 3 times per week. Soil and ball exercises, with emphasis on the pelvic region. The program began with the work of breathing and postural correction, with warm-up exercises or preparatory, followed by the framework of classical movements of the method. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Voluntary
- Female
- 18-25 years old
- Enrolled in Physiotherapy course at the State University of Piauí- UESPI, with symptoms compatible with primary, nulliparous dysmenorrhoea, who have regular menstrual cycle and who agree to participate spontaneously in the research, by signing a term of informed consent (Appendix a) in accordance with Resolution 466/2012.
- Participation in the survey did not veto the use of analgesic or contraceptive by the participants.
Key exclusion criteria (3 listed)
- Will not be included in the selected research volunteers that do not show symptoms and characteristics consistent with primary dysmenorrhoea according to the questionnaire, and those who accept not participate and / or not signing the consent form sample.
- As criteria for inclusion are also not chronic back pain, regular physical activity (3 or more times per week), women with pathological picture associated or malformation of the pelvic organs (secondary dysmenorrhea), or those that make use of device Intra- uterus (IUD).
- Will be excluded from the sample participants who submit two consecutive absences to care.
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 |
|---|---|---|
| Pilates exercisesPilates exercises with emphasis on pelvic region | Behavioural | Pilates Group |
Primary outcome
Pain, Visual analog scale
Time frame: two months
Effects of pilates method in pain
Quality of health, score Short Form-36
Time frame: two months
Effects of pilates method in quality of health
1 secondary outcome
Flexibility, finger-ground test
Time frame: two months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 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.
Juliany M A da Fonseca, Principal principal investigator
Universidade Estadual do PiauÍ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates exercises in people with Pain, run by Universidade Estadual do PiauÍ at 1 site in Brazil.
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 6 inclusion and 3 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 26 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 Brazil. 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 Juliany M A da Fonseca, Principal ((86) 81644967, juliany.markes@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain, Visual analog scale (time frame: two months). 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?
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 26 Nov 2014.