NCT02584712

Brief Summary

The aim of this study is to evaluate the effect of exercise training in the autonomic nervous system activity in breast cancer patients, who underwent doxorubicin medication.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 23, 2015

Completed
Last Updated

October 23, 2015

Status Verified

October 1, 2015

Enrollment Period

11 months

First QC Date

October 20, 2015

Last Update Submit

October 21, 2015

Conditions

Breast NeoplasmsAutonomic Nervous System Diseases

Outcome Measures

Primary Outcomes (2)

  • Reduction in Low Frequency Heart rate variability component (LF)

    This reduction is positive, indicating a reduction in sympathetic activity and thus the cardiovascular risk

    4 weeks

  • Increase in High Frequency heart rate variability component (HF)

    Means a increase in parasympathetic activity, which is correlated to reduction in cardiovascular risk

    4 weeks

Study Arms (2)

Control

NO INTERVENTION

This group do not participated in the intervention protocol (exercise training), and was followed throughout the entire process. Autonomic activity was assessed before and after 4 weeks.

Exercise Training

ACTIVE COMPARATOR

This group undergone exercise training intervention during 4 weeks.

Other: Combined Exercise Training

Interventions

Combined Exercise TrainingOTHER

This intervention consisted in 4 weeks of strength, flexibility and aerobic exercises made at the hospital and at home.

Also known as: Exercise
Exercise Training

Eligibility Criteria

Age30 Years - 59 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Breast cancer patients at stages 1, 2 and 3;
  • Sedentary;
  • Currently at treatment;
  • months after surgery

You may not qualify if:

  • Musculoskeletal injuries or disorders;
  • Mental illnesses
  • Stage 4 (Metastasis)
  • Enrolled in other exercise program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast NeoplasmsAutonomic Nervous System Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Cristiano T Mostarda, PhD

    Federal University of Maranhao

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Teacher and Investigator

Study Record Dates

First Submitted

October 20, 2015

First Posted

October 23, 2015

Study Start

January 1, 2014

Primary Completion

December 1, 2014

Last Updated

October 23, 2015

Record last verified: 2015-10