Pilates and Dance to Breast Cancer Patients Undergoing Treatment

NCT03194997 | Completed DMC

• 1 other identifier: 2.073.549
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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%.

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

Outcome Measures

Primary Outcomes (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.

  10 minutes

Secondary Outcomes (19)

• Depressive Symptoms

  10 minutes

• Body image

  10 minutes

• Self-Esteem

  5 minutes

• Optimism

  5 minutes

• Stress

  5 minutes

Study Arms (3)

Dance

EXPERIMENTAL

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).

Other: Dance

Pilates

EXPERIMENTAL

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).

Other: Pilates

Control

NO INTERVENTION

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.

Interventions

Dance OTHER

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.

Dance

Pilates OTHER

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.

Pilates

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Laboratório de Pesquisa em Lazer e Atividade Física: lead
• Centro de Pesquisas Oncológicas: collaborator

Study Sites (1)

Santa Catarina State University

Florianópolis, Santa Catarina, 88080-350, Brazil

Location

Related Publications (3)

• 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.

  PMID: 36715766 DERIVED

• 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.

  PMID: 36403344 DERIVED

• 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.

  PMID: 31910872 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Lymphedema; Fatigue; Depression; Sexual Dysfunctions, Psychological; Parasomnias; Pain; Muscle Weakness; Sleep Initiation and Maintenance Disorders

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Pathologic Processes; Sleep Disorders, Intrinsic; Dyssomnias

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics

Study Officials

• Leonessa Boing, MSc

  University of the State of Santa Catarina

  PRINCIPAL INVESTIGATOR

• Adriana CA Guimarães, PhD

  University of the State of Santa Catarina

  STUDY DIRECTOR

• Tatiana B Fretta

  University of the State of Santa Catarina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized clinical trial, three-arm study (group 1 - Dance; group 2 - Pilates and group 3 - Control), single-blinded.

Study Record Dates

• First Submitted: June 16, 2017
• First Posted: June 22, 2017
• Study Start: January 1, 2018
• Primary Completion: December 10, 2019
• Study Completion: December 30, 2020
• Last Updated: June 14, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)