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
|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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||57 participants|
|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)|
|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|
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).
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.
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).
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.
- 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.
- 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.
- Body image [ Time Frame: 10 minutes ]Body Image After Breast Cancer (BIBCQ) - Scores 0 to 45. Higher the score worst is the body image.
- Self-Esteem [ Time Frame: 5 minutes ]Rosenberg Self Esteem Scale - Scores 0 to 40 points. Higher the score better is the self-esteem.
- 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.
- Stress [ Time Frame: 5 minutes ]Perceived Stress Scale - Scores 0 to 56 points. Higher scores are associated with greater perceived stress.
- 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.
- 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.
- 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.
- Pain level [ Time Frame: 3 minutes ]Visual Analog Scale - 0 to 10 points. Nearer to 10 indicates more pain.
- Cardiorespiratory fitness [ Time Frame: 10 minutes ]Six-Minute Walk Test - Vo2max estimation
- Physical Activity [ Time Frame: 10 minutes ]International Physical Activity Questionnaire - sedentary; insufficiently active; and very active and minutes per day.
- 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.
- Muscular Strength [ Time Frame: 15 minutes ]Chatillôn® Portable Digital Dynamometer - Maximal force in Newton.
- Range of motion [ Time Frame: 15 minutes ]Carci goniometer - Maximal Angle
- Posture [ Time Frame: 10 minutes ]Postural evaluation - Postural alterations; Hyperlordosis; Hyperkyphosis; Shoulder protrusion; Scoliosis; Pelvic anteversion; Valgus genus; Anterior head.
- Flexibility [ Time Frame: 10 minutes ]Sit and reach test - Wells Bank - Maximum of the line.
- 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.
- Lymphedema [ Time Frame: 15 minutes ]Arm volume in centimeters
- 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).
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
|Santa Catarina State University|
|Florianópolis, Santa Catarina, Brazil, 88080-350|
|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|