Physical Training on Patients With Breast Cancer

Not Applicable

Completed

• Conditions: Breast Cancer Female
• Interventions: Behavioral: Conventional hospital treatment; Other: Exercise

• Registration Number: NCT03061773
• Lead Sponsor: Federal University of Maranhao

Brief Summary

The treatment of breast cancer at any given time can be through surgery, as well as adjuvant treatments (radiotherapy, chemotherapy and hormone therapy) alone or together. And with this the patient tends to lose weight, he becomes depressed, resulting in an increasingly debilitating picture. Therefore, the present study aims to investigate the relationship between physical exercise and its effects on quality of life in patients with breast cancer, those who underwent surgery for at least 6 months, patients who are still with the Tumor using the adjuvant treatments submitted to physical exercises and not submitted. The sample will consist of 25 to 50 female patients aged 18 to 75 years. Patients will be submitted to the initial quality of life evaluation (SF - 36 reduced version, Anxiety and depression (HAD Scale), Fatigue (Piper Fatigue Scale), Pain (Brief Inventory of Pain), Body Composition (Bioimpedance BYODINAMICS 450 ) And oxidative stress markers (oxidized and reduced glutathione, TBARS / MDA, Myeloperoxidase and Creatinine), inflammatory markers (IL1, IL6, IL8, IL10, MCP-1 and TNF-α), hormones Estrogen, progesterone), blood test (complete blood count) 24 hour food recall (24hs food recall), and perform the maximum repetition test to find the initial workload that will be adjusted every 4 weeks with the evaluation of the load and Completing the 12 weeks of training will be reevaluated following the initial evaluation. The data collected will be treated statistically with an α=5% using the software Stata 12.0.

Detailed Description

The patients will be allocated into two groups: exercise group (intervention) and conventional treatment group (active comparison). Intervention: The combined training program consisted of 12-week aerobic, resistive and flexibility exercises, with 3 sessions per week of aerobic and resistive training in the same session (supervised by physical exercise coaches) and 2 sessions per week of Flexibility training (unsupervised). As stretching sessions were interspersed with sessions of aerobic and weathered training in the daytime period.

Study Timeline

• Study Start: 2014-03-01
• Primary Completion: 2015-09-01
• Study Completion: 2015-09-30
• Status Verified: 2017-02
• Study First Submitted: 2017-02-14
• Study First Submitted QC: 2017-02-19
• Last Update Submitted: 2017-02-19
• Study First Posted: 2017-02-23
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2

Inclusion Criteria

• Breast cancer patients;
• Sedentary;
• Currently at treatment and clinical follow-up.

Exclusion Criteria

• Musculoskeletal injuries or disorders;
• Mental illnesses;
• Enrolled in other exercise program.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group did not exercise	Conventional hospital treatment	Group did not exercise: conventional hospital treatment
Exercise group	Exercise	Exercise group: physical training lasting 12 weeks, after detraining and in the end the control group receives physical training

Primary Outcome Measures

Name	Time	Method
Measure the pain, The Brief Pain Inventory (BPI).	12 weeks	Reduction of pain due to increased functional capacity

Secondary Outcome Measures

Name	Time	Method
Measure the Fatigue; The revised piper fatigue scale (PFS-R).	12 weeks	Reduction of fatigue due to increased functional capacity