The Effect of Physical Exercise in Reducing Pain in Women Undergoing Mammography

August 11, 2014 updated by: Altacílio Aparecido Nunes, University of Sao Paulo

Impact of Physical Exercise, Aimed at Reducing Pain in Women Who Underwent Mammography.

Mammography is a systematic way in the main programs of screening for breast cancer in women over 40 or 50 years old, according to screening programs, but most research has shown a frequency of discomfort and pain during the examination mammography. This study is a randomized controlled trial, whose intervention will be a sequence of exercises body warming and muscle stretching, performed systematic manner and supervised by a physical educator. It is expected to find in this study a possible impact of physical exercise in reducing pain after mammography examination.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This research aims to evaluate the relationship of pre-mammography guided physical activity and pain after the examination, evaluating the impact of the intervention in a group of patients undergoing upper limb exercise (SLE), compared to another group women not subject exposure (MNE), and another group with lower limb exercise (LLE). This study is a randomized controlled trial, whose intervention will be a sequence of exercises body warming and muscle stretching, performed systematic manner and supervised by a physical educator. It is expected to find in this study a possible impact of physical exercise in reducing pain after mammography examination. The results will be checked by study association between the level of physical activity, body mass index, breast density and reducing the pain effect between groups for comparison of means and variances of values of the visual analogue scale (VAS).

Study Type

Interventional

Enrollment (Anticipated)

198

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
    • Sao Paulo
      • Barretos, Sao Paulo, Brazil, 14780000
        • Recruiting
        • Hospital do Cancer de Barretos
        • Contact:
        • Contact:
          • Tadeu
        • Sub-Investigator:
          • Tadeu Cardoso, MSc

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

20 years to 69 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women: 20 to 69 years old

Exclusion Criteria:

  • Cardiovascular disease
  • Mental diseases
  • Pulmonary diseases
  • Steroids use

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

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: No physical exercise
Women are never subjected to any exercise prior to mammography.
EXPERIMENTAL: Physical exercise (Upper limb)
Women will be subjected to physical exercise on upper limb prior to mammography.
Procedure: Physical exercise
Exercise muscle stretching and body warming.
Other Names:
  • Physical activity
ACTIVE_COMPARATOR: Group 2
Women are subjected to physical exercise in the lower limbs prior to mammography
Procedure: Physical exercise
Exercise muscle stretching and body warming.
Other Names:
  • Physical activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decreased pain after mammography.
Time Frame: Decrease in pain after performing mammography, checked10 minutes after the procedure e, measured by visual analog scale.
Following the randomization, approximately 10 minutes after performing a physical exercise in the upper limbs (Group 1) and lower (Group 2), or not performing any physical exercise (Group 0), the woman will be submitted to bilateral mammogram. Ten minutes after the procedure, the assessment of pain during mammography will be measured by the visual analog scale. The mean difference between the measurements of visual analog scale (VAS) will be compared between groups.
Decrease in pain after performing mammography, checked10 minutes after the procedure e, measured by visual analog scale.

Collaborators and Investigators

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

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Altacilio A Nunes, MD; Ph.D, Ribeirão Preto Medical School - USP

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

August 1, 2014

Primary Completion (ANTICIPATED)

October 1, 2014

Study Completion (ANTICIPATED)

November 1, 2014

Study Registration Dates

First Submitted

August 9, 2014

First Submitted That Met QC Criteria

August 11, 2014

First Posted (ESTIMATE)

August 13, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

August 13, 2014

Last Update Submitted That Met QC Criteria

August 11, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 313.907

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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