Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03194997 |
| Other study ID # |
2.073.549 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2018 |
| Est. completion date |
December 30, 2020 |
Study information
| Verified date |
June 2021 |
| Source |
Laboratório de Pesquisa em Lazer e Atividade Física |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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%.
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.
