- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03194997
Pilates and Dance to Breast Cancer Patients Undergoing Treatment
Pilates and Dance to Breast Cancer Patients Undergoing Treatment: MoveMama Project
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Santa Catarina
-
Florianópolis, Santa Catarina, Brazil, 88080-350
- Santa Catarina State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Dance
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 Dance intervention will be performed with belly dance methods.
It will occur 3 times per week, during 16 weeks, with 60 minutes the session.
|
EXPERIMENTAL: Pilates
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 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.
|
NO_INTERVENTION: Control
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perception of Quality of life
Time Frame: 10 minutes
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depressive Symptoms
Time Frame: 10 minutes
|
Beck's Depression Inventory - The scores goes from 0 to 63, and the higher score indicates more presence of depressive symptoms.
|
10 minutes
|
Body image
Time Frame: 10 minutes
|
Body Image After Breast Cancer (BIBCQ) - Scores 0 to 45. Higher the score worst is the body image.
|
10 minutes
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Self-Esteem
Time Frame: 5 minutes
|
Rosenberg Self Esteem Scale - Scores 0 to 40 points.
Higher the score better is the self-esteem.
|
5 minutes
|
Optimism
Time Frame: 5 minutes
|
Life Orientation Test - (LOT-R) 0 to 40.
It is determined that the higher the score, the greater the patients' optimism.
|
5 minutes
|
Stress
Time Frame: 5 minutes
|
Perceived Stress Scale - Scores 0 to 56 points.
Higher scores are associated with greater perceived stress.
|
5 minutes
|
Fatigue
Time Frame: 5 minutes
|
Functional Assessment of Cancer Therapy-Fatigue (FACT-F) - Scores 0 to 52, a higher score indicates a level of less perceived fatigue.
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5 minutes
|
Sexual function
Time Frame: 10 minutes
|
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.
|
10 minutes
|
Sleep Quality
Time Frame: 10 minutes
|
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.
|
10 minutes
|
Pain level
Time Frame: 3 minutes
|
Visual Analog Scale - 0 to 10 points.
Nearer to 10 indicates more pain.
|
3 minutes
|
Cardiorespiratory fitness
Time Frame: 10 minutes
|
Six-Minute Walk Test - Vo2max estimation
|
10 minutes
|
Physical Activity
Time Frame: 10 minutes
|
International Physical Activity Questionnaire - sedentary; insufficiently active; and very active and minutes per day.
|
10 minutes
|
Upper limb function
Time Frame: 15 minutes
|
Disabilities of the Arm, Shoulder and Hand (DASH) - Scores 0 to 100.
Higher the score worse the functionality of the upper limb.
|
15 minutes
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Muscular Strength
Time Frame: 15 minutes
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Chatillôn® Portable Digital Dynamometer - Maximal force in Newton.
|
15 minutes
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Range of motion
Time Frame: 15 minutes
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Carci goniometer - Maximal Angle
|
15 minutes
|
Posture
Time Frame: 10 minutes
|
Postural evaluation - Postural alterations; Hyperlordosis; Hyperkyphosis; Shoulder protrusion; Scoliosis; Pelvic anteversion; Valgus genus; Anterior head.
|
10 minutes
|
Flexibility
Time Frame: 10 minutes
|
Sit and reach test - Wells Bank - Maximum of the line.
|
10 minutes
|
Balance
Time Frame: 15 minutes
|
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.
|
15 minutes
|
Lymphedema
Time Frame: 15 minutes
|
Arm volume in centimeters
|
15 minutes
|
Cardiorrespiratory fitness
Time Frame: 30 minutes
|
Submaximal incremental exercise test (85% of maximum heart rate - HRmax) will be performed using a cycle ergometer (Lode Excalibur Sport, Groningen, the Netherlands).
|
30 minutes
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Leonessa Boing, MSc, University of the State of Santa Catarina
- Principal Investigator: Tatiana B Fretta, University of the State of Santa Catarina
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Skin Diseases
- Neoplasms
- Lymphatic Diseases
- Sleep Wake Disorders
- Neoplasms by Site
- Neurologic Manifestations
- Breast Diseases
- Musculoskeletal Diseases
- Muscular Diseases
- Neuromuscular Manifestations
- Depression
- Breast Neoplasms
- Fatigue
- Lymphedema
- Muscle Weakness
- Dyssomnias
- Parasomnias
Other Study ID Numbers
- 2.073.549
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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