Clinical trial NCT04116281: Short and Long Term Effects of a Physical Therapy Program After Breast Cancer Surgery
Official title: Study of the Possible Sensory, Biomechanical, Cardiorespiratory and Quality of Life Adaptations Associated With Physical Therapy Rehabilitation in the Short and Long Term Postoperative of Breast Cancer
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Breast Cancer
Keywords: Upper limb function
Heart hate variability
Physical therapy
Breast neoplasms
Pressure pain threshold
Perceived pain
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
First posted: 2019-10-04
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: TREATMENT

Brief summary: Objectives: To evaluate the pressure pain threshold, shoulder biomechanics, cardiorespiratory function and the quality of life associated with the short and long-term physical therapy rehabilitation following breast cancer surgery. Methodology: The study presents three objectives and involves three groups of participants. Objective 1 is to develop a topographic map of pressure pain in the shoulder (using a digital pressure algometer), evaluate the biomechanics of the shoulder (using a digital inclinometer and load card), cardiorespiratory function (through frequency variability resting heart rate and distance traveled, through the six-minute walk test) and quality of life (through questionnaires of quality of life, anxiety, depression, sleep quality, upper limb functionality, fatigue and level of physical activity) between a group of women prior to the operation of breast cancer (experimental group, n = 36) and a group of asymptomatic controls for shoulder pain (control group, n = 18). Objective 2 is to evaluate the possible changes in the pain map over 24 weeks of supervised kinetic intervention (Supervised Physiotherapy experimental group, n = 18, will begin after drainage, frequency 3 times per week and duration of 60 minutes each session) compared to unsupervised kinetic intervention (Home Physiotherapy experimental group, n = 18, participants will receive an exercise booklet). Objective 3 is to evaluate the biomechanics of the shoulder, cardiorespiratory function and the quality of life with respect to the experimental group with and without kinesic supervision. To achieve objective 1, two baseline evaluations will be carried out in both experimental and control groups (considering the month prior to the surgery of the experimental group) and the average of the evaluations will be considered evaluation 1. To achieve objectives 2 and 3, evaluation 2 (after 4 weeks of intervention), 3 (after 12 weeks of intervention) and 4 (after 24 weeks of intervention) will be performed. The statistical analysis will include the examination of qualitative and quantitative variables. Statistical tests will be applied according to the normality of the data and a significance level of 5% will be adopted for all comparisons. Expected results: It is expected to identify sensory, biomechanical, cardiorespiratory and quality of life alterations in the experimental group, compared to the control group. In addition, after 24 weeks of intervention, the supervised experimental group will show improvement in all the aforementioned variables with respect to the unsupervised group.


Eligibility criteria: Inclusion Criteria:

* Surgical indication of conservative or removal breast surgery, associated with axillary lymphadenectomy or sentinel lymph node biopsy
* Any type of breast cancer
* Age range over 18 years

Exclusion Criteria:

* Breast cancer recurrence;
* Surgical treatment for bilateral breast cancer;
* Presence of lymphedema in the upper limb, measured by means of cirtometry of the upper limb with a measuring tape 14, asymmetries of more than 1.5 cm between the limbs were considered edema;
* Diagnosis of metastases;
* Shoulder pain compatible with shoulder compression symptoms as determined by the positive Hawkins-Kennedy test 30;
* Previous history of surgery and fractures in the upper extremities.

Primary outcomes:
measure: Pressure pain threshold over the shoulder of breast cancer patients after a physical therapy rehabilitation program following the surgery.
timeFrame: Three months
measure: Pressure pain threshold over the shoulder of breast cancer patients after a physical therapy rehabilitation program following the surgery.
timeFrame: Six months
measure: Strength grip of breast cancer patients after a physical therapy rehabilitation program following the surgery.
timeFrame: Three months
measure: Strength grip of breast cancer patients after a physical therapy rehabilitation program following the surgery.
timeFrame: Six months
Secondary outcomes:
measure: Upper limb functionality of breast cancer patients after a physical therapy rehabilitation program following the surgery.
timeFrame: Three months
measure: Upper limb functionality of breast cancer patients after a physical therapy rehabilitation program following the surgery.
timeFrame: Six months
measure: Fatigue of breast cancer patients after a physical therapy rehabilitation program following the surgery.
timeFrame: Three months
measure: Fatigue of breast cancer patients after a physical therapy rehabilitation program following the surgery.
timeFrame: Six months
measure: Cardiopulmonary function of breast cancer patients after a physical therapy rehabilitation program following the surgery.
timeFrame: Three months
measure: Cardiopulmonary function of breast cancer patients after a physical therapy rehabilitation program following the surgery.
timeFrame: Six months
measure: Cardiopulmonary function of breast cancer patients after a physical therapy rehabilitation program following the surgery.
timeFrame: Three months
measure: Cardiopulmonary function of breast cancer patients after a physical therapy rehabilitation program following the surgery.
timeFrame: Six months
measure: Quality of life of breast cancer patients after a physical therapy rehabilitation program following the surgery.
timeFrame: Three months
measure: Quality of life of breast cancer patients after a physical therapy rehabilitation program following the surgery.
timeFrame: Six months
Other outcomes:
Locations:
city: Talca
country: Chile
facility: Catholic University of Maule
state: Maule
Study officials:
affiliation: Universidad Católica del Maule
name: Ivana L Ribeiro, PhD
role: PRINCIPAL_INVESTIGATOR
References: