Domiciliary Physiotherapy During Breast Cancer Radiation
|ClinicalTrials.gov Identifier: NCT02198118|
Recruitment Status : Completed
First Posted : July 23, 2014
Last Update Posted : July 23, 2014
|Condition or disease||Intervention/treatment||Phase|
|Shoulder Pain||Other: Domiciliary exercises for the upper limbs||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Domiciliary Physiotherapy During Breast Cancer Radiation|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||December 2012|
No Intervention: Control Group
Control group (CG) subjected only to evaluations and to no exercises.
Experimental: Study Group
Study group (SG) instructed to perform domiciliary exercises for the upper limbs
Other: Domiciliary exercises for the upper limbs
Study group (SG) instructed to perform domiciliary exercises for the upper limbs.
- Gain in range of movement measured in degrees [ Time Frame: Three months ]The volunteers were evaluated at three distinct times: pre-RT (first evaluation), post-RT (second evaluation) and 2 months after the end of RT (third evaluation). The following parameters were evaluated: ROM of shoulder joint and upper limb perimetry. To assess shoulder ROM, the movements of flexion, extension, abduction, adduction, internal rotation and external rotation were measured, with each movement being performed by subjects. The volunteers were randomly divided into 2 groups: a control group (CG) subjected only to evaluations and to no exercise, and a study group (SG) instructed to perform domiciliary exercises for the upper limbs. The plan randomization was performed by a computer program that generated a list with the allotment of cases to the two groups. The allocation was randomized, but not concealed.
- Improvement of lymphedema measured in centimeters [ Time Frame: Three months ]Lymphedema was evaluated during the period of the study through perimetry measurements that were made at 6 different points: point A -metacarpophalangeal joint of the 2nd, 3rd, 4th and 5th fingers; point B - an imaginary line passing through the metacarpophalangeal joint of the thumb; point C - 10 cm below the olecranon; point D - 6 cm below the olecranon; point E - 6 cm above the olecranon, and point F - 10 cm above the olecranon 20. The volunteer should be sitting, with her arm resting on her thigh and the forearm supinated. The measurements were bilateral and carried out by the same observer.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02198118
|Hospital das Clínicas de Ribeirão Preto|
|Ribeirão Preto, SP, Brazil, 14048900|
|Study Chair:||Nara FB Leal, Master||University of Sao Paulo|