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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2014 by Altacílio Aparecido Nunes, University of Sao Paulo.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02215668
First Posted: August 13, 2014
Last Update Posted: August 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Altacílio Aparecido Nunes, University of Sao Paulo
  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
Intervention Model: Parallel Assignment
Masking: Single (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 Altacílio Aparecido Nunes, 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. ]
    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

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Ages Eligible for Study:   20 Years to 69 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: August 9, 2014
First Posted: August 13, 2014
Last Update Posted: August 13, 2014
Last Verified: August 2014