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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Altacílio Aparecido Nunes, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT02215668
First received: August 9, 2014
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Pain
Side Effects
Procedure: Physical exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Impact of Physical Exercise, Aimed at Reducing Pain in Women Who Underwent Mammography.

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Decreased pain after mammography. [ Time Frame: Decrease in pain after performing mammography, checked10 minutes after the procedure e, measured by visual analog scale. ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 198
Study Start Date: August 2014
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Physical activity

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).

  Eligibility

Ages Eligible for Study:   20 Years to 69 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women: 20 to 69 years old

Exclusion Criteria:

  • Cardiovascular disease
  • Mental diseases
  • Pulmonary diseases
  • Steroids use
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02215668

Contacts
Contact: Altacilio A Nunes, Ph.D +551636022884 altacilio@fmrp.usp.br
Contact: Tadeu Cardoso, MSc +5517981132313 tadeucardoso@hotmail.com

Locations
Brazil
Hospital do Cancer de Barretos Recruiting
Barretos, Sao Paulo, Brazil, 14780000
Contact: Altacilio A Nunes, MD; Ph,D    +551636022884    altacilio@fmrp.usp.br   
Contact: Tadeu         
Sub-Investigator: Tadeu Cardoso, MSc         
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Altacilio A Nunes, MD; Ph.D Ribeirao Preto Medical School - USP
  More Information

No publications provided

Responsible Party: Altacílio Aparecido Nunes, Full professor; MD; Ph.D., University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02215668     History of Changes
Other Study ID Numbers: 313.907
Study First Received: August 9, 2014
Last Updated: August 11, 2014
Health Authority: Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research

ClinicalTrials.gov processed this record on September 18, 2014