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

NCT ID: NCT02215668

Last Updated: 2014-08-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2014-11-30

Brief Summary

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.

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).

Conditions

Pain; Side Effects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

No physical exercise

Women are never subjected to any exercise prior to mammography.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Physical exercise (Upper limb)

Women will be subjected to physical exercise on upper limb prior to mammography.

Group Type: EXPERIMENTAL

Physical exercise

Intervention Type: PROCEDURE

Exercise muscle stretching and body warming.

Group 2

Women are subjected to physical exercise in the lower limbs prior to mammography

Group Type: ACTIVE_COMPARATOR

Physical exercise

Intervention Type: PROCEDURE

Exercise muscle stretching and body warming.

Interventions

Physical exercise

Exercise muscle stretching and body warming.

Intervention Type: PROCEDURE

Other Intervention Names

Physical activity

Eligibility Criteria

Inclusion Criteria

• Women: 20 to 69 years old

Exclusion Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Altacílio Aparecido Nunes

Full professor; MD; Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Altacilio A Nunes, MD; Ph.D

Role: PRINCIPAL_INVESTIGATOR

Ribeirao Preto Medical School - USP

Locations

Hospital do Cancer de Barretos

Barretos, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Altacilio A Nunes, Ph.D

Role: CONTACT

altacilio@fmrp.usp.br

+551636022884

Tadeu Cardoso, MSc

Role: CONTACT

tadeucardoso@hotmail.com

+5517981132313

Facility Contacts

Altacilio A Nunes, MD; Ph,D

Role: primary

altacilio@fmrp.usp.br

+551636022884

Tadeu

Role: backup

Other Identifiers

313.907

Identifier Type: -

Identifier Source: org_study_id