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Breast CancerNCT03194997

Pilates and Dance to Breast Cancer Patients Undergoing Treatment

A study testing Dance and Pilates in people with Breast Cancer and Quality of Life, run by Laboratório de Pesquisa em Lazer e Atividade Física at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer, Quality of Life, Lymphedema
What is being tested?
Dance and Pilates
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
1 siteBrazil
Study dates
1 Jan 2018to 30 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • Santa Catarina State University

    Florianópolis, Santa Catarina, 88080-350

Other trials in Brazil

About this study

Official title: Pilates and Dance to Breast Cancer Patients Undergoing Treatment: MoveMama Project

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%.

Read the 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.

Being tested
Dance, Pilates
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
Medical subject headings
Breast Neoplasms, Lymphedema, Fatigue, Depression, Sexual Dysfunctions, Psychological, Parasomnias, Pain, Muscle Weakness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DanceOther

    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.

  • PilatesOther

    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.

Study groups in NCT03194997
Study groupRoleWhat they receive
DanceExperimentalThe 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).
Receives: Other: Dance
PilatesExperimentalThe 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).
Receives: Other: Pilates
ControlNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 10 minutes

Secondary outcomes (19)
  1. Depressive Symptoms

    Beck's Depression Inventory - The scores goes from 0 to 63, and the higher score indicates more presence of depressive symptoms.

    Measured: 10 minutes

  2. Body image

    Body Image After Breast Cancer (BIBCQ) - Scores 0 to 45. Higher the score worst is the body image.

    Measured: 10 minutes

  3. Self-Esteem

    Rosenberg Self Esteem Scale - Scores 0 to 40 points. Higher the score better is the self-esteem.

    Measured: 5 minutes

  4. Optimism

    Life Orientation Test - (LOT-R) 0 to 40. It is determined that the higher the score, the greater the patients' optimism.

    Measured: 5 minutes

  5. Stress

    Perceived Stress Scale - Scores 0 to 56 points. Higher scores are associated with greater perceived stress.

    Measured: 5 minutes

  6. Fatigue

    Functional Assessment of Cancer Therapy-Fatigue (FACT-F) - Scores 0 to 52, a higher score indicates a level of less perceived fatigue.

    Measured: 5 minutes

  7. 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.

    Measured: 10 minutes

  8. 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.

    Measured: 10 minutes

  9. Pain level

    Visual Analog Scale - 0 to 10 points. Nearer to 10 indicates more pain.

    Measured: 3 minutes

  10. Cardiorespiratory fitness

    Six-Minute Walk Test - Vo2max estimation

    Measured: 10 minutes

  11. Physical Activity

    International Physical Activity Questionnaire - sedentary; insufficiently active; and very active and minutes per day.

    Measured: 10 minutes

  12. 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.

    Measured: 15 minutes

  13. Muscular Strength

    Chatillôn® Portable Digital Dynamometer - Maximal force in Newton.

    Measured: 15 minutes

  14. Range of motion

    Carci goniometer - Maximal Angle

    Measured: 15 minutes

  15. Posture

    Postural evaluation - Postural alterations; Hyperlordosis; Hyperkyphosis; Shoulder protrusion; Scoliosis; Pelvic anteversion; Valgus genus; Anterior head.

    Measured: 10 minutes

  16. Flexibility

    Sit and reach test - Wells Bank - Maximum of the line.

    Measured: 10 minutes

  17. 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.

    Measured: 15 minutes

  18. Lymphedema

    Arm volume in centimeters

    Measured: 15 minutes

  19. 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).

    Measured: 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2017
  2. Study start1 Jan 2018
  3. Primary completion10 Dec 2019
  4. Study completion30 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
A randomized clinical trial, three-arm study (group 1 - Dance; group 2 - Pilates and group 3 - Control), single-blinded.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03194997
Sponsor's protocol ID
2.073.549
Status last verified
Jun 2021
First submitted
16 Jun 2017
Last updated
14 Jun 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Boing L, Raimundo JAG, Pereira GS, de Bem Fretta T, Fausto DY, Martins JBB, da Silveira J, Benetti M, Bergmann A, de Azevedo Guimaraes AC. Mat Pilates vs. belly dance: Effects on cardiorespiratory fitness and body composition in women with breast cancer: A randomized trial. Maturitas. 2026 Aug;211:109024. doi: 10.1016/j.maturitas.2026.109024. Epub 2026 Jun 10.

    PubMed 42296761
  • Boing L, de Bem Fretta T, Dias M, Marinho A, Lynch B, Bergmann A, da Silveira J, Groth LA, de Azevedo Guimaraes AC. What are the effects of pilates and dance on upper limb functionality in women post-breast cancer surgery? a randomized three-arm clinical trial. Support Care Cancer. 2026 Feb 12;34(3):189. doi: 10.1007/s00520-026-10362-1.

    PubMed 41673315
  • Boing L, de Bem Fretta T, Stein F, Lyra VB, Moratelli JA, da Silveira J, Dos Santos Saraiva PS, Bergmann A, Lynch BM, de Azevedo Guimaraes AC. Can mat Pilates and belly dance be effective in improving body image, self-esteem, and sexual function in patients undergoing hormonal treatment for breast cancer? A randomized clinical trial. Arch Womens Ment Health. 2023 Apr;26(2):141-151. doi: 10.1007/s00737-023-01294-4. Epub 2023 Jan 30.

    PubMed 36715766
  • Boing L, Fretta TB, Lynch BM, Dias M, Rosa LMD, Baptista F, Bergmann A, Fausto DY, Bocchi Martins JB, Guimaraes ACA. Mat Pilates and belly dance: Effects on patient-reported outcomes among breast cancer survivors receiving hormone therapy and adherence to exercise. Complement Ther Clin Pract. 2023 Feb;50:101683. doi: 10.1016/j.ctcp.2022.101683. Epub 2022 Nov 5.

    PubMed 36403344
  • 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.

    PubMed 31910872

Questions about this trial

What is this clinical trial studying?

A study testing Dance and Pilates in people with Breast Cancer and Quality of Life, run by Laboratório de Pesquisa em Lazer e Atividade Física at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perception of Quality of life (time frame: 10 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03194997, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.

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