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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02301559
Other study ID # 04008402357J
Secondary ID
Status Recruiting
Phase N/A
First received November 16, 2014
Last updated November 25, 2014
Start date September 2014
Est. completion date December 2014

Study information

Verified date November 2014
Source Universidade Estadual do PiauÍ
Contact Juliany M A da Fonseca, Principal
Phone (86) 81644967
Email juliany.markes@hotmail.com
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical 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. 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.


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 PiauĂ­-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.


Recruitment information / eligibility

Status Recruiting
Enrollment 11
Est. completion date December 2014
Est. primary completion date November 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria:

- Voluntary

- Female

- 18-25 years old

- Enrolled in Physiotherapy course at the State University of PiauĂ­- 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

Exclusion Criteria:

- 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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Pilates exercises
Pilates exercises with emphasis on pelvic region

Locations

Country Name City State
Brazil Universidade Estadual do Piaui Teresina Piaui

Sponsors (1)

Lead Sponsor Collaborator
Universidade Estadual do PiauÍ

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain, Visual analog scale Effects of pilates method in pain two months No
Primary Quality of health, score Short Form-36 Effects of pilates method in quality of health two months No
Secondary Flexibility, finger-ground test Effects of pilates method in flexibility two months No
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