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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
Federal University of Maranhao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer Female

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    February 14, 2017
    Last Updated
    February 19, 2017
    Sponsor
    Federal University of Maranhao
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    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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