Effect of Exercise Training in Autonomic Modulation in Breast Cancer Patients

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02584712
• Other study ID #: FUMaranhao
• Status: Completed
• Phase: N/A
• First received: October 20, 2015
• Last updated: October 21, 2015
• Start date: January 2014

Study information

• Verified date: October 2015
• Source: Federal University of Maranhao
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 59 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autonomic Nervous System Diseases
• Breast Neoplasms
• Nervous System Diseases
• Primary Dysautonomias

Intervention

Other:
• Combined Exercise Training
This intervention consisted in 4 weeks of strength, flexibility and aerobic exercises made at the hospital and at home.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Maranhao

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No