Physical Training on Patients With Breast Cancer
Primary Purpose
Breast Cancer Female
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise
Conventional hospital treatment
Sponsored by

About this trial
This is an interventional treatment trial for Breast Cancer Female
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exercise group
Group did not exercise
Arm Description
Exercise group: physical training lasting 12 weeks, after detraining and in the end the control group receives physical training
Group did not exercise: conventional hospital treatment
Outcomes
Primary Outcome Measures
Measure the pain, The Brief Pain Inventory (BPI).
Reduction of pain due to increased functional capacity
Secondary Outcome Measures
Measure the Fatigue; The revised piper fatigue scale (PFS-R).
Reduction of fatigue due to increased functional capacity
Full Information
NCT ID
NCT03061773
First Posted
February 14, 2017
Last Updated
February 19, 2017
Sponsor
Federal University of Maranhao
1. Study Identification
Unique Protocol Identification Number
NCT03061773
Brief Title
Physical Training on Patients With Breast Cancer
Official Title
Benefits of Physical Exercise in Patients With Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 1, 2014 (Actual)
Primary Completion Date
September 1, 2015 (Actual)
Study Completion Date
September 30, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Maranhao
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise group
Arm Type
Experimental
Arm Description
Exercise group: physical training lasting 12 weeks, after detraining and in the end the control group receives physical training
Arm Title
Group did not exercise
Arm Type
Active Comparator
Arm Description
Group did not exercise: conventional hospital treatment
Intervention Type
Other
Intervention Name(s)
Exercise
Other Intervention Name(s)
Physical exercise
Intervention Description
Physical training: 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.
Intervention Type
Behavioral
Intervention Name(s)
Conventional hospital treatment
Intervention Description
Conventional hospital treatment: The patients did not perform physical training
Primary Outcome Measure Information:
Title
Measure the pain, The Brief Pain Inventory (BPI).
Description
Reduction of pain due to increased functional capacity
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Measure the Fatigue; The revised piper fatigue scale (PFS-R).
Description
Reduction of fatigue due to increased functional capacity
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JOÃO BS GARCIA, Doctor
Organizational Affiliation
Federal University of Maranhão
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24460069
Citation
Backman M, Wengstrom Y, Johansson B, Skoldengen I, Borjesson S, Tarnbro S, Berglund A. A randomized pilot study with daily walking during adjuvant chemotherapy for patients with breast and colorectal cancer. Acta Oncol. 2014 Apr;53(4):510-20. doi: 10.3109/0284186X.2013.873820. Epub 2014 Jan 24.
Results Reference
background
PubMed Identifier
25834616
Citation
Do J, Cho Y, Jeon J. Effects of a 4-week multimodal rehabilitation program on quality of life, cardiopulmonary function, and fatigue in breast cancer patients. J Breast Cancer. 2015 Mar;18(1):87-96. doi: 10.4048/jbc.2015.18.1.87. Epub 2015 Mar 27.
Results Reference
background
PubMed Identifier
26068412
Citation
Nyrop KA, Callahan LF, Rini C, Altpeter M, Hackney B, Schecher A, Wilson A, Muss HB. Adaptation of an Evidence-Based Arthritis Program for Breast Cancer Survivors on Aromatase Inhibitor Therapy Who Experience Joint Pain. Prev Chronic Dis. 2015 Jun 11;12:E91. doi: 10.5888/pcd12.140535.
Results Reference
background
PubMed Identifier
22258395
Citation
Sullivan AB, Scheman J, Venesy D, Davin S. The role of exercise and types of exercise in the rehabilitation of chronic pain: specific or nonspecific benefits. Curr Pain Headache Rep. 2012 Apr;16(2):153-61. doi: 10.1007/s11916-012-0245-3.
Results Reference
background
PubMed Identifier
26050790
Citation
Travier N, Velthuis MJ, Steins Bisschop CN, van den Buijs B, Monninkhof EM, Backx F, Los M, Erdkamp F, Bloemendal HJ, Rodenhuis C, de Roos MA, Verhaar M, ten Bokkel Huinink D, van der Wall E, Peeters PH, May AM. Effects of an 18-week exercise programme started early during breast cancer treatment: a randomised controlled trial. BMC Med. 2015 Jun 8;13:121. doi: 10.1186/s12916-015-0362-z.
Results Reference
background
PubMed Identifier
29625622
Citation
Reis AD, Pereira PTVT, Diniz RR, de Castro Filha JGL, Dos Santos AM, Ramallo BT, Filho FAA, Navarro F, Garcia JBS. Effect of exercise on pain and functional capacity in breast cancer patients. Health Qual Life Outcomes. 2018 Apr 6;16(1):58. doi: 10.1186/s12955-018-0882-2.
Results Reference
derived
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Physical Training on Patients With Breast Cancer
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