Back to resultsEffect of Exercise Training in Autonomic Modulation in Breast Cancer Patients
Primary Purpose
Breast Neoplasms, Autonomic Nervous System Diseases
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Combined Exercise Training
Sponsored by
About this trial
This is an interventional treatment trial for Breast Neoplasms
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Control
Exercise Training
Arm Description
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.
This group undergone exercise training intervention during 4 weeks.
Outcomes
Primary Outcome Measures
Reduction in Low Frequency Heart rate variability component (LF)
This reduction is positive, indicating a reduction in sympathetic activity and thus the cardiovascular risk
Increase in High Frequency heart rate variability component (HF)
Means a increase in parasympathetic activity, which is correlated to reduction in cardiovascular risk
Secondary Outcome Measures
Full Information
NCT ID
NCT02584712
First Posted
October 20, 2015
Last Updated
October 21, 2015
Sponsor
Federal University of Maranhao
1. Study Identification
Unique Protocol Identification Number
NCT02584712
Brief Title
Effect of Exercise Training in Autonomic Modulation in Breast Cancer Patients
Official Title
Effect of Exercise Training in Autonomic Modulation in Breast Cancer Patients Treated With Doxorubicin
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Maranhao
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Autonomic Nervous System Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Exercise Training
Arm Type
Active Comparator
Arm Description
This group undergone exercise training intervention during 4 weeks.
Intervention Type
Other
Intervention Name(s)
Combined Exercise Training
Other Intervention Name(s)
Exercise
Intervention Description
This intervention consisted in 4 weeks of strength, flexibility and aerobic exercises made at the hospital and at home.
Primary Outcome Measure Information:
Title
Reduction in Low Frequency Heart rate variability component (LF)
Description
This reduction is positive, indicating a reduction in sympathetic activity and thus the cardiovascular risk
Time Frame
4 weeks
Title
Increase in High Frequency heart rate variability component (HF)
Description
Means a increase in parasympathetic activity, which is correlated to reduction in cardiovascular risk
Time Frame
4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristiano T Mostarda, PhD
Organizational Affiliation
Federal University of Maranhao
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Effect of Exercise Training in Autonomic Modulation in Breast Cancer Patients
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