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Pilates and Dance to Breast Cancer Patients Undergoing Treatment

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ClinicalTrials.gov Identifier: NCT03194997
Recruitment Status : Enrolling by invitation
First Posted : June 22, 2017
Last Update Posted : August 29, 2019
Sponsor:
Collaborator:
Centro de Pesquisas Oncológicas
Information provided by (Responsible Party):
Laboratório de Pesquisa em Lazer e Atividade Física

Brief Summary:
Breast cancer is one of the most common types of cancer in Brazil, and its treatment, namely surgery, chemotherapy, radiotherapy or hormone therapy, has consequences and side effects that significantly affect the quality of life and associated physical and psychological factors. The practice of physical activity, in turn, may play a beneficial role in these factors, and help the recovery of the patient in relation to the consequences of the treatments. Two types of physical activity can be addressed in the context of breast cancer; Dance and the Pilates method. Thus, the objective of the present study will be to analyze the impact of Pilates practice and dance on quality of life and on psychological and physical factors in patients undergoing adjuvant treatment of breast cancer. Patients older than 18 years who are in adjuvant treatment, namely, chemotherapy, radiotherapy and / or hormone therapy at the Oncology Research Center - CEPON, will be invited to be part of the study. With a randomized clinical trial of three arms, the patients will be submitted to 16 weeks of intervention, and randomized in 3 groups: (A) belly dance protocol group; (B) Pilates method protocol group, and (C) control group who will continue with their routine activities. Sample randomization will be conducted in confidence by one of the researchers in a specific computer program. Information about personal and clinical characteristics, quality of life, psychological factors (depressive symptoms, body image, self-esteem, optimism, perceived stress, fatigue, pain, sexual function and sleep quality) and physical factors (cardiorespiratory fitness, balance , Posture, upper limb functionality and presence of lymphedema). All information will be collected before and after the intervention period. Statistical analysis will use the statistical package SPSS - IBM, version 20.0. Firstly, descriptive statistics (mean, standard deviation and percentage) will be used in order to know the data, and then the Anova two way test with repeated measurements and Sydak Comparison Test, in order to analyze the data. Groups of the Pilates method, of the dance and control group. Significance level of 5%.

Condition or disease Intervention/treatment Phase
Breast Cancer Quality of Life Lymphedema Fatigue Depressive Symptoms Body Image Self Esteem Optimism Sexual Function Disturbances Stress Sleep Disturbance Pain Muscular Weakness Postural Balance Range of Motion Cardiorespiratory Fitness Other: Dance Other: Pilates Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: A randomized clinical trial, three-arm study (group 1 - Dance; group 2 - Pilates and group 3 - Control), single-blinded.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilates and Dance to Breast Cancer Patients Undergoing Treatment: MoveMama Project
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Dance
The group randomized to Dance intervention will receive a 3-week intervention with belly dance classes. The classes will be divided in: Warm up and stretching (10 minutes), Main part with belly dance steps and movements (40 minutes) and relaxation (10 minutes).
Other: Dance
The Dance intervention will be performed with belly dance methods. It will occur 3 times per week, during 16 weeks, with 60 minutes the session.

Experimental: Pilates
The group randomized to Pilates intervention will receive a 3-week intervention with Pilates Methods. The classes will be divided in: Warm up and stretching (10 minutes), Main part with Pilates exercises (40 minutes) and relaxation (10 minutes).
Other: Pilates
The Pilates intervention will be performed using specific exercises of Pilates Methods. During the classes it will be used thera band, toning ball and pilates ball. It will occur 3 times per week, during 16 weeks, with 60 minutes the session.

No Intervention: Control
The group randomized to Control group will be invited to maintain routine activities and be contacted by phone every two months and will receive an explanatory booklet on the benefits of physical activity after diagnosis of breast cancer as well as instructions on lymphedema prevention. Also, this group will be invited to three meeting during the 16 weeks of intervention, the first meeting will focus on stretching exercise to develop at home, a second meeting will be about self-esteem and the last meeting will be about prevented of lymphedema. The women in this group will not receive a dance or pilates intervention.



Primary Outcome Measures :
  1. Perception of Quality of life [ Time Frame: 10 minutes ]
    European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30 and BR23). Scores range from zero to 100, and the higher the score, the better the quality of life on functional and general health scales, and the smaller the score, worse is the quality of life on the symptomatic scale.


Secondary Outcome Measures :
  1. Depressive Symptoms [ Time Frame: 10 minutes ]
    Beck's Depression Inventory - The scores goes from 0 to 63, and the higher score indicates more presence of depressive symptoms.

  2. Body image [ Time Frame: 10 minutes ]
    Body Image After Breast Cancer (BIBCQ) - Scores 0 to 45. Higher the score worst is the body image.

  3. Self-Esteem [ Time Frame: 5 minutes ]
    Rosenberg Self Esteem Scale - Scores 0 to 40 points. Higher the score better is the self-esteem.

  4. Optimism [ Time Frame: 5 minutes ]
    Life Orientation Test - (LOT-R) 0 to 40. It is determined that the higher the score, the greater the patients' optimism.

  5. Stress [ Time Frame: 5 minutes ]
    Perceived Stress Scale - Scores 0 to 56 points. Higher scores are associated with greater perceived stress.

  6. Fatigue [ Time Frame: 5 minutes ]
    Functional Assessment of Cancer Therapy-Fatigue (FACT-F) - Scores 0 to 52, a higher score indicates a level of less perceived fatigue.

  7. Sexual function [ Time Frame: 10 minutes ]
    Female Sexual Function Index (FSFI) - Scores 2 to 36 points, considering that the higher the score obtained, the better the sexual function of the woman.

  8. Sleep Quality [ Time Frame: 10 minutes ]
    Pittsburgh Sleep Quality Index - Scores 0 to 21, scores up to five determine a quality sleep ball, and scores greater than five points distinguish poor sleep quality.

  9. Pain level [ Time Frame: 3 minutes ]
    Visual Analog Scale - 0 to 10 points. Nearer to 10 indicates more pain.

  10. Cardiorespiratory fitness [ Time Frame: 10 minutes ]
    Six-Minute Walk Test - Vo2max estimation

  11. Physical Activity [ Time Frame: 10 minutes ]
    International Physical Activity Questionnaire - sedentary; insufficiently active; and very active and minutes per day.

  12. Upper limb function [ Time Frame: 15 minutes ]
    Disabilities of the Arm, Shoulder and Hand (DASH) - Scores 0 to 100. Higher the score worse the functionality of the upper limb.

  13. Muscular Strength [ Time Frame: 15 minutes ]
    Chatillôn® Portable Digital Dynamometer - Maximal force in Newton.

  14. Range of motion [ Time Frame: 15 minutes ]
    Carci goniometer - Maximal Angle

  15. Posture [ Time Frame: 10 minutes ]
    Postural evaluation - Postural alterations; Hyperlordosis; Hyperkyphosis; Shoulder protrusion; Scoliosis; Pelvic anteversion; Valgus genus; Anterior head.

  16. Flexibility [ Time Frame: 10 minutes ]
    Sit and reach test - Wells Bank - Maximum of the line.

  17. Balance [ Time Frame: 15 minutes ]
    MINIBESTest Equilibrium Assessment Systems Test - Each item is scored on a four-point ordinal scale, in which zero is the worst performance and three best performance.

  18. Lymphedema [ Time Frame: 15 minutes ]
    Arm volume in centimeters

  19. Cardiorrespiratory fitness [ Time Frame: 30 minutes ]
    Submaximal incremental exercise test (85% of maximum heart rate - HRmax) will be performed using a cycle ergometer (Lode Excalibur Sport, Groningen, the Netherlands).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stage I to III of breast cancer;
  • Be in adjuvant treatment with chemotherapy, radiation therapy or hormone therapy;
  • Receive the release of the oncologist responsible for the practice of physical activity, as well as the Physical Therapy Sector of CEPON.

Exclusion Criteria:

  • Present some orthopedic or neurological limitation that not allows the practice of physical activity.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194997


Locations
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Brazil
Santa Catarina State University
Florianópolis, Santa Catarina, Brazil, 88080-350
Sponsors and Collaborators
Laboratório de Pesquisa em Lazer e Atividade Física
Centro de Pesquisas Oncológicas
Investigators
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Principal Investigator: Leonessa Boing, MSc University of the State of Santa Catarina
Study Director: Adriana CA Guimarães, PhD University of the State of Santa Catarina
Principal Investigator: Tatiana B Fretta University of the State of Santa Catarina

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Responsible Party: Laboratório de Pesquisa em Lazer e Atividade Física
ClinicalTrials.gov Identifier: NCT03194997     History of Changes
Other Study ID Numbers: 2.073.549
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laboratório de Pesquisa em Lazer e Atividade Física:
Breast Cancer
Quality of life
Lymphedema
Fatigue
Depressive symptoms
Body image
Self Esteem
Optimism
Sexual function
Stress
Sleep quality
Pain
Muscular strength
Postural
Balance
Range of motion
Cardiorespiratory fitness
Additional relevant MeSH terms:
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Breast Neoplasms
Muscle Weakness
Dyssomnias
Sleep Wake Disorders
Parasomnias
Lymphedema
Fatigue
Depression
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms
Lymphatic Diseases
Behavioral Symptoms
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Pathologic Processes