NCT02215668

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
198

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Aug 2014

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

August 13, 2014

Status Verified

August 1, 2014

Enrollment Period

2 months

First QC Date

August 9, 2014

Last Update Submit

August 11, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Decreased pain after mammography.

    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.

Study Arms (3)

No physical exercise

NO INTERVENTION

Women are never subjected to any exercise prior to mammography.

Physical exercise (Upper limb)

EXPERIMENTAL

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

Procedure: Physical exercise

Group 2

ACTIVE COMPARATOR

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

Procedure: Physical exercise

Interventions

Exercise muscle stretching and body warming.

Also known as: Physical activity
Group 2Physical exercise (Upper limb)

Eligibility Criteria

Age20 Years - 69 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women: 20 to 69 years old

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital do Cancer de Barretos

Barretos, São Paulo, 14780000, Brazil

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Altacilio A Nunes, MD; Ph.D

    Ribeirao Preto Medical School - USP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Altacilio A Nunes, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full professor; MD; Ph.D.

Study Record Dates

First Submitted

August 9, 2014

First Posted

August 13, 2014

Study Start

August 1, 2014

Primary Completion

October 1, 2014

Study Completion

November 1, 2014

Last Updated

August 13, 2014

Record last verified: 2014-08

Locations