Clinical trial NCT03194997: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Laboratório de Pesquisa em Lazer e Atividade Física
Sponsor class: OTHER
Collaborators: name: Centro de Pesquisas Oncológicas
First posted: 2017-06-22
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: A randomized clinical trial, three-arm study (group 1 - Dance; group 2 - Pilates and group 3 - Control), single-blinded.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Perception of Quality of life
timeFrame: 10 minutes
Secondary outcomes:
measure: Depressive Symptoms
timeFrame: 10 minutes
measure: Body image
timeFrame: 10 minutes
measure: Self-Esteem
timeFrame: 5 minutes
measure: Optimism
timeFrame: 5 minutes
measure: Stress
timeFrame: 5 minutes
measure: Fatigue
timeFrame: 5 minutes
measure: Sexual function
timeFrame: 10 minutes
measure: Sleep Quality
timeFrame: 10 minutes
measure: Pain level
timeFrame: 3 minutes
measure: Cardiorespiratory fitness
timeFrame: 10 minutes
measure: Physical Activity
timeFrame: 10 minutes
measure: Upper limb function
timeFrame: 15 minutes
measure: Muscular Strength
timeFrame: 15 minutes
measure: Range of motion
timeFrame: 15 minutes
measure: Posture
timeFrame: 10 minutes
measure: Flexibility
timeFrame: 10 minutes
measure: Balance
timeFrame: 15 minutes
measure: Lymphedema
timeFrame: 15 minutes
measure: Cardiorrespiratory fitness
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Florianópolis
country: Brazil
facility: Santa Catarina State University
state: Santa Catarina
Study officials:
affiliation: University of the State of Santa Catarina
name: Leonessa Boing, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of the State of Santa Catarina
name: Adriana CA Guimarães, PhD
role: STUDY_DIRECTOR
affiliation: University of the State of Santa Catarina
name: Tatiana B Fretta
role: PRINCIPAL_INVESTIGATOR
References:
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.