Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03333993 |
| Other study ID # |
64099717.7.0000.5274 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 15, 2017 |
| Est. completion date |
December 10, 2019 |
Study information
| Verified date |
November 2019 |
| Source |
Instituto Nacional de Cancer, Brazil |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Breast cancer is the most frequent tumor site among women in the world (FERLAY et al., 2015).
In Brazil, estimates for the year 2017 indicate the occurrence of about 57,960 new cases
(56.2 cases per 100,000 women); (Brazil - Ministry of Health, 2015). The increase in adjuvant
therapies resulted in an estimated increase of 22 million cancer survivors worldwide
(GOLDSTEIN et al., 2012). However, as survival rates increased, more women faced
complications related to diagnosis and treatment (ABRAHMS et al., 2016). Adjuvant
radiotherapy is a frequent treatment in breast cancer and fatigue it is the main adverse
effects (HICKOK et al., 2005). Measures of intervention through physical activity have shown
benefits in the increase of the functional capacity that generates a reduction of effort and
decrease of the fatigue (MARKES et al., 2009). General Objective: To evaluate the influence
of Mat Pilates on fatigue, quality of life, functional capacity, flexibility, lymphedema,
radiodermatitis and depression, in the women with breast cancer and with an indication of
adjuvant radiotherapy, at the Cancer Hospital III of the National Cancer Institute (INCA).
After recruitment, women will be allocated randomly in: Intervention Group (Mat Pilates and
usual activities) and Control Group (usual activities). Patients in the intervention group
will be submitted to 10 sessions of Mat Pilates for a period of 5 weeks (from beginning to
end of adjuvant radiotherapy). Patients assigned to the control group will not participate in
the Mat Pilates program, but will maintain the usual exercises for upper limbs, guided by
physiotherapists in the postoperative period. In both groups, patients will be submitted,
functional capacity assessment, flexibility assessment, assessment of the presence of
lymphedema, and questionnaire application of fatigue, quality of life, level of physical
activity and depression. Will be performed a descriptive analysis of the population.
Univariate logistic regression will be performed between the outcomes according to the
exercise groups and also, for the possible confounding variables. The variables with p<0.20
will be selected for adjustment in the construction of the multiple logistic regression
model. Those with p<0.05 and/or with clinical significance will be maintained in the model.
Description:
After recruitment, women will be randomly assigned to: Intervention Group (Mat Pilates and
usual activities) and Control Group (usual activities). At patients in the intervention group
will be submitted to 10 sessions of Mat Pilates for a period of 5 weeks (from beginning to
end of adjuvant radiotherapy). The Mat Pilates program will be based on group sessions with
the supervision of physiotherapists specialized in technique. The groups will consist of a
maximum of 4 patients, to achieve the basic principles of the technique that include
concentration, control, accuracy and fluidity of movement. Mat Pilates sessions will be held
in the physiotherapy gymnasium of Cancer Hospital III / INCA. The Mat Pilates program will be
held twice a week and the duration of sessions will be 60 minutes, consisting of 5 minutes of
exercises 50 minutes of strengthening exercises with flexibilization of the muscular fibers,
where the concentric phase of the movement will be performed at the expiration, followed by 5
minutes of relaxation and stretching. The movements will be carried out slowly and with the
maximum of 2 sets of 10 replicates. The Swiss ball and elastic band accessories will be used.
The Mat Pilates intensity exercises will be controlled by means of the adapted Borg Scale
(0-10), where the perception of the effort will vary from 2 (very light) to 7
(moderate-intense). On days of the week in which the patient will not practice the Mat
Pilates program, the usual upper limb exercises will be maintained by the physiotherapists on
the first postoperative day at Cancer Hospital III / INCA. Patients allocated to the control
group will not participate in the Mat Pilates program, but will be directed to maintain the
usual exercises for upper limbs, guided by physiotherapists in the postoperative. In both
groups, the patients will be submitted, the functional capacity evaluation composed of the
Disability Arm, Shoulder and Hand (DASH) questionnaire, flexibility assessment, presence of
lymphedema, radiodermatitis and application of the questionnaires International Questionnaire
of Physical Activity (IPAQ), Functional Assessment of Cancer Therapy- Fatigue (FACT-F) for
Fatigue, European Organization for Research and Treatment of Cancer (EORTC) Quality of Life
Questionnaire (QLQ) Core-30 (EORTC QLQ-C30) and specific module EORTC QLQ Breast-23 (EORTC
QLQ-BR23) for quality of life, and Geriatric Depression Scale(GDS) for depression at the time
of study inclusion and in the follow-up (end of radiotherapy, 30 days and 6 months after
end).
