Effect of Exercise Training in Autonomic Modulation in Breast Cancer Patients

Effect of Exercise Training in Autonomic Modulation in Breast Cancer Patients Treated With Doxorubicin

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.

Study Overview

• Status: Completed
• Conditions: Breast Neoplasms; Autonomic Nervous System Diseases
• Intervention / Treatment: Other: Combined Exercise Training

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 59 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Breast cancer patients at stages 1, 2 and 3;
• Sedentary;
• Currently at treatment;
• 4-6 months after surgery

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; 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.
Active Comparator: Exercise Training; This group undergone exercise training intervention during 4 weeks.	Other: Combined Exercise Training; This intervention consisted in 4 weeks of strength, flexibility and aerobic exercises made at the hospital and at home.; Other Names: Exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Federal University of Maranhao
• Investigators: Principal Investigator: Cristiano T Mostarda, PhD, Federal University of Maranhao

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: October 20, 2015
• First Submitted That Met QC Criteria: October 21, 2015
• First Posted (Estimate): October 23, 2015

Study Record Updates

• Last Update Posted (Estimate): October 23, 2015
• Last Update Submitted That Met QC Criteria: October 21, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Nervous System Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases
• Other Study ID Numbers: FUMaranhao