Physical Activity and Sexuality After Reduction Mammaplasty

July 5, 2013 updated by: Daniela Francescato Veiga

Satisfaction, Physical Activity and Sexuality Outcomes in Breast Reduction Patients

This prospective controlled trial was designed to determine whether breast reduction may influence physical activity and sexuality of breast hypertrophy women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Breast hypertrophy is a frequent condition among women; reduction mammaplasty is one of the most performed procedures in plastic surgery.Previous studies have demonstrated that breast hypertrophy is associated to back pain, and patients often complain about physical limitations due to this condition, as well as sexual impairment. Thus, this trial was designed to test the hypothesis that reduction mammaplasty may improve physical and sexual performance of breast hypertrophy patients,and patients'satisfaction with the results of the operation. Three validated tools were used: the International Physical Activity Questionnaire (IPAQ), the Female Sexual Quotient and the Breast Evaluation Questionnaire.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 04024002
        • Hospital Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • breast hypertrophy
  • candidate to reduction mammaplasty
  • body mass index under 30Kg/m2
  • women with sexual activity

Exclusion Criteria:

  • pregnancy, delivery or breast feeding during the last 12 months
  • body mass index over 30Kg/m2
  • breast cancer history
  • previous breast surgery
  • smoking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Breast reduction
Breast hypertrophy women allocated to this arm will undergo reduction mammaplasty
Procedure: reduction mammaplasty
conventional reduction mammaplasty
Other: Control
Patients in this arm will be assessed twice, without surgical intervention
Other: control
follow up, questionnaire responses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
physical activity
Time Frame: 6 months
Physical activity will be assessed by a validated instrument, the International Physical Activity Questionnaire (IPAQ), at pre-operative and 6 months after breast reduction
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient's satisfaction
Time Frame: 6 months
Patient's satisfaction will be assessed after 6 months, by the Breast Evaluation Questionnaire
6 months
Sexuality
Time Frame: 6 months
Sexuality will be assessed by a brazilian validated questionnaire, the Female Sexual Quotient, at preoperative and sixth postoperative month
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daniela Francescato Veiga

Investigators

  • Study Director: Daniela F Veiga, MD, PhD, Federal University of São Paulo
  • Study Chair: Lydia M Ferreira, MD, PhD, Federal University of São Paulo
  • Principal Investigator: Vanessa L Resende, MD, Federal University of São Paulo
  • Study Director: Miguel Sabino-Neto, MD, PhD, Federal University of São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

February 16, 2011

First Submitted That Met QC Criteria

February 16, 2011

First Posted (Estimate)

February 17, 2011

Study Record Updates

Last Update Posted (Estimate)

July 9, 2013

Last Update Submitted That Met QC Criteria

July 5, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mestre 1
  • 0651/10 (Other Identifier: Ethical Commitee)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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