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Pilates and Dance to Breast Cancer Patients Undergoing Treatment

Primary Purpose

Breast Cancer, Quality of Life, Lymphedema

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Dance
Pilates
Sponsored by
Laboratório de Pesquisa em Lazer e Atividade Física
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring 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

Eligibility Criteria

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

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.

Sites / Locations

  • Santa Catarina State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Dance

Pilates

Control

Arm Description

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 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 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.

Outcomes

Primary Outcome Measures

Perception of Quality of life
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

Depressive Symptoms
Beck's Depression Inventory - The scores goes from 0 to 63, and the higher score indicates more presence of depressive symptoms.
Body image
Body Image After Breast Cancer (BIBCQ) - Scores 0 to 45. Higher the score worst is the body image.
Self-Esteem
Rosenberg Self Esteem Scale - Scores 0 to 40 points. Higher the score better is the self-esteem.
Optimism
Life Orientation Test - (LOT-R) 0 to 40. It is determined that the higher the score, the greater the patients' optimism.
Stress
Perceived Stress Scale - Scores 0 to 56 points. Higher scores are associated with greater perceived stress.
Fatigue
Functional Assessment of Cancer Therapy-Fatigue (FACT-F) - Scores 0 to 52, a higher score indicates a level of less perceived fatigue.
Sexual function
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
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
Visual Analog Scale - 0 to 10 points. Nearer to 10 indicates more pain.
Cardiorespiratory fitness
Six-Minute Walk Test - Vo2max estimation
Physical Activity
International Physical Activity Questionnaire - sedentary; insufficiently active; and very active and minutes per day.
Upper limb function
Disabilities of the Arm, Shoulder and Hand (DASH) - Scores 0 to 100. Higher the score worse the functionality of the upper limb.
Muscular Strength
Chatillôn® Portable Digital Dynamometer - Maximal force in Newton.
Range of motion
Carci goniometer - Maximal Angle
Posture
Postural evaluation - Postural alterations; Hyperlordosis; Hyperkyphosis; Shoulder protrusion; Scoliosis; Pelvic anteversion; Valgus genus; Anterior head.
Flexibility
Sit and reach test - Wells Bank - Maximum of the line.
Balance
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
Arm volume in centimeters
Cardiorrespiratory fitness
Submaximal incremental exercise test (85% of maximum heart rate - HRmax) will be performed using a cycle ergometer (Lode Excalibur Sport, Groningen, the Netherlands).

Full Information

First Posted
June 16, 2017
Last Updated
June 10, 2021
Sponsor
Laboratório de Pesquisa em Lazer e Atividade Física
Collaborators
Centro de Pesquisas Oncológicas
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1. Study Identification

Unique Protocol Identification Number
NCT03194997
Brief Title
Pilates and Dance to Breast Cancer Patients Undergoing Treatment
Official Title
Pilates and Dance to Breast Cancer Patients Undergoing Treatment: MoveMama Project
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 10, 2019 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratório de Pesquisa em Lazer e Atividade Física
Collaborators
Centro de Pesquisas Oncológicas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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%.
Detailed Description
The MoveMama Project includes two protocols: (1) Dance and (2) Pilates. Each session for each modality will last 60 minutes, three times a week, for 16 weeks. In both groups, a chart of patient evolution will be developed during the protocol, which should be updated every week by the researchers responsible for the intervention. In order to control the intensity and safety of the practice of physical activity, since they are about patients who are in period of clinical adjuvant treatment. In this way, the blood pressure (BP), through a sphygmomanometer, and the investigation of the heart rate (HR) will be performed in every first class of the week at the beginning and end of the session. The Subjective Effort Perception Scale - Borg Scale 6-20 points (BORG, 2000) will also be used to evaluate the intensity and / or discomfort during physical activity practice in both protocols. This 6 to 20-point scale can be used efficiently because of its relationship to heart rate. It should be applied to describe resting sensations to situations of maximum physical effort, considering number six equivalent to 60 bpm (beats per minute), as well as number 20 to 200 bpm (Table 2) (FOSS et al., 2000). In both modalities of intervention, the evolution of the movements of upper limbs will always be respecting the limit of each patient. The dance protocol (1) will be performed through the belly dance method. This type of methodology was selected, because it is a practice that involves an intimate relationship between movement and emotion, awakens a spontaneous body language that privileges movements that respect the individuality of each practitioner, for the recovery of the feminine identity, and for be a practice that proposes intense movements of the upper limbs, benefiting patients directly. Classes will proceed in the following order: (a) Initial stretching: The sequence of movements lesson will span wide to specific joint movements, including flexion, extension, abduction, adduction and rotation, initiated by the upper body until reaching the lower limbs, with an expected duration of 10 minutes. (b) Main part: brief explanations about the purpose of the lesson, that is, the theory of dance or the specific step to be worked, followed by the practical part of teaching the technique. The purpose of this moment will be to develop in the students the movements of the belly dance technique, stimulating the motor coordination, the rhythm and the corporal consciousness, improving aspects of the flexibility and the range of movement of the upper limb. The practice of the movements will be explored in individual dynamics, in double or in group, involving the movement according to the rhythm of the music, or also, by rhythms stipulated by the students. This class session will last an average of 40 minutes. (c) Relaxation: Developed from slow-moving practices. With normalization of cardiac frequency, this part will last 10 minutes. Finally, at the end of each class, a brief discussion will be carried out on each student's perception of the contents given, and in relation to the objectives discussed at the beginning of the lesson, whether they were reached or not. The Pilates protocol (2) will proceed in the following order: (a) Initial stretching: The breathig, imprint & release, hip release, spinal rotation, cat stretch, hip rolls, scapula isolation, arm circles, head nods and elevation & depression of scapulae exercises will be performed during warm-up in all sessions, then in the 10th session Added theraband, tonning ball and ball, intensifying the exercises. Duration of 10 minutes. (b) Main part: brief explanations about the purpose of the lesson, the theory of Pilates, the basic principles of Joseph Pilates: breathing, centering, control, precision, fluency and concentration. Clarify the positions: positioning of the pelvis, positioning of the rib cage, stabilization and movement of the shoulder girdle and positioning of the head and cervical spine. This part will include the specific exercises in Pilates. The practice of the movements will be explored in individual dynamics. This class session will last an average of 40 minutes. (c) Relaxation: The relaxation will consist of the exercises: sitting on the ball, sitting on the spine stretch forward ball, sitting on the self-stretching ball of the cervical muscles (Upper Trapezius and Muscle Scalene muscles) and active mobilization of the cervical spine during the 48 sessions. Duration of 10 minutes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
A randomized clinical trial, three-arm study (group 1 - Dance; group 2 - Pilates and group 3 - Control), single-blinded.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dance
Arm Type
Experimental
Arm Description
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).
Arm Title
Pilates
Arm Type
Experimental
Arm Description
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).
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Dance
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Pilates
Intervention Description
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.
Primary Outcome Measure Information:
Title
Perception of Quality of life
Description
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.
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Depressive Symptoms
Description
Beck's Depression Inventory - The scores goes from 0 to 63, and the higher score indicates more presence of depressive symptoms.
Time Frame
10 minutes
Title
Body image
Description
Body Image After Breast Cancer (BIBCQ) - Scores 0 to 45. Higher the score worst is the body image.
Time Frame
10 minutes
Title
Self-Esteem
Description
Rosenberg Self Esteem Scale - Scores 0 to 40 points. Higher the score better is the self-esteem.
Time Frame
5 minutes
Title
Optimism
Description
Life Orientation Test - (LOT-R) 0 to 40. It is determined that the higher the score, the greater the patients' optimism.
Time Frame
5 minutes
Title
Stress
Description
Perceived Stress Scale - Scores 0 to 56 points. Higher scores are associated with greater perceived stress.
Time Frame
5 minutes
Title
Fatigue
Description
Functional Assessment of Cancer Therapy-Fatigue (FACT-F) - Scores 0 to 52, a higher score indicates a level of less perceived fatigue.
Time Frame
5 minutes
Title
Sexual function
Description
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.
Time Frame
10 minutes
Title
Sleep Quality
Description
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.
Time Frame
10 minutes
Title
Pain level
Description
Visual Analog Scale - 0 to 10 points. Nearer to 10 indicates more pain.
Time Frame
3 minutes
Title
Cardiorespiratory fitness
Description
Six-Minute Walk Test - Vo2max estimation
Time Frame
10 minutes
Title
Physical Activity
Description
International Physical Activity Questionnaire - sedentary; insufficiently active; and very active and minutes per day.
Time Frame
10 minutes
Title
Upper limb function
Description
Disabilities of the Arm, Shoulder and Hand (DASH) - Scores 0 to 100. Higher the score worse the functionality of the upper limb.
Time Frame
15 minutes
Title
Muscular Strength
Description
Chatillôn® Portable Digital Dynamometer - Maximal force in Newton.
Time Frame
15 minutes
Title
Range of motion
Description
Carci goniometer - Maximal Angle
Time Frame
15 minutes
Title
Posture
Description
Postural evaluation - Postural alterations; Hyperlordosis; Hyperkyphosis; Shoulder protrusion; Scoliosis; Pelvic anteversion; Valgus genus; Anterior head.
Time Frame
10 minutes
Title
Flexibility
Description
Sit and reach test - Wells Bank - Maximum of the line.
Time Frame
10 minutes
Title
Balance
Description
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.
Time Frame
15 minutes
Title
Lymphedema
Description
Arm volume in centimeters
Time Frame
15 minutes
Title
Cardiorrespiratory fitness
Description
Submaximal incremental exercise test (85% of maximum heart rate - HRmax) will be performed using a cycle ergometer (Lode Excalibur Sport, Groningen, the Netherlands).
Time Frame
30 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonessa Boing, MSc
Organizational Affiliation
University of the State of Santa Catarina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adriana CA Guimarães, PhD
Organizational Affiliation
University of the State of Santa Catarina
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tatiana B Fretta
Organizational Affiliation
University of the State of Santa Catarina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Santa Catarina State University
City
Florianópolis
State/Province
Santa Catarina
ZIP/Postal Code
88080-350
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31910872
Citation
Boing L, do Bem Fretta T, de Carvalho Souza Vieira M, Pereira GS, Moratelli J, Sperandio FF, Bergmann A, Baptista F, Dias M, de Azevedo Guimaraes AC. Pilates and dance to patients with breast cancer undergoing treatment: study protocol for a randomized clinical trial - MoveMama study. Trials. 2020 Jan 7;21(1):35. doi: 10.1186/s13063-019-3874-6.
Results Reference
derived

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Pilates and Dance to Breast Cancer Patients Undergoing Treatment

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