Short and Long Term Effects of a Physical Therapy Program After Breast Cancer Surgery

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04116281
• Other study ID #: 154/2019
• Status: Suspended
• Phase: N/A
• Start date: December 2, 2019
• Est. completion date: February 25, 2024

Study information

• Verified date: July 2022
• Source: Universidade Federal de Sao Carlos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 36
• Est. completion date: February 25, 2024
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Rehabilitation after breast cancer surgery
All participants are going to receive physical therapy intervention after breast cancer surgery at least removal drenaige. After that, will be randomized in two groups: Group 1 are going to receive a physical therapy program supervised by a physiotherapist; Group 2 are going to receive some instructions about the same program to perfomr at home without supervision. Both groups are going to receive 3 and 6 months of rehabilitation program.

Locations

Country	Name	City	State
Chile	Catholic University of Maule	Talca	Maule

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Sao Carlos

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure pain threshold over the shoulder of breast cancer patients after a physical therapy rehabilitation program following the surgery.	This outcome will involve data regarding to pressure pain threshold assessment over the shoulder at three and six monthes of treatment.	Three months
Primary	Pressure pain threshold over the shoulder of breast cancer patients after a physical therapy rehabilitation program following the surgery.	This outcome will involve data regarding to pressure pain threshold assessment over the shoulder at three and six monthes of treatment.	Six months
Primary	Strength grip of breast cancer patients after a physical therapy rehabilitation program following the surgery.	This outcome will involve data regarding to objective measurement that consist in to do a maximal strenth grip. The unity of measurement it is in kg.	Three months
Primary	Strength grip of breast cancer patients after a physical therapy rehabilitation program following the surgery.	This outcome will involve data regarding to objective measurement that consist in to do a maximal strenth grip. The unity of measurement it is in kg.	Six months
Secondary	Upper limb functionality of breast cancer patients after a physical therapy rehabilitation program following the surgery.	This outcome will involve data regarding to a questionnaire of upper limb function during activity daily routine. The questionnaire has 33 questions and each one has 5 posible answers.	Three months
Secondary	Upper limb functionality of breast cancer patients after a physical therapy rehabilitation program following the surgery.	This outcome will involve data regarding to a questionnaire of upper limb function during activity daily routine. The questionnaire has 33 questions and each one has 5 posible answers.	Six months
Secondary	Fatigue of breast cancer patients after a physical therapy rehabilitation program following the surgery.	This outcome will involve data regarding to a questionnaire wich contains 9 preguntas and 10 differente posibilities of answers.	Three months
Secondary	Fatigue of breast cancer patients after a physical therapy rehabilitation program following the surgery.	This outcome will involve data regarding to a questionnaire wich contains 9 questions and 10 different posibilities of answers.	Six months
Secondary	Cardiopulmonary function of breast cancer patients after a physical therapy rehabilitation program following the surgery.	This outcome will involve data regarding to functional capacity performed wiht the walking test measured by the distance performed after a walking.	Three months
Secondary	Cardiopulmonary function of breast cancer patients after a physical therapy rehabilitation program following the surgery.	This outcome will involve data regarding to functional capacity performed wiht the walking test measured by the distance performed after a walking.	Six months
Secondary	Cardiopulmonary function of breast cancer patients after a physical therapy rehabilitation program following the surgery.	This outcome will involve data regarding to heart rate variability measured with a Polar and reloj in a supine and orthostatic posture	Three months
Secondary	Cardiopulmonary function of breast cancer patients after a physical therapy rehabilitation program following the surgery.	This outcome will involve data regarding to heart rate variability measured with a Polar and reloj in a supine and orthostatic posture	Six months
Secondary	Quality of life of breast cancer patients after a physical therapy rehabilitation program following the surgery.	This outcome will involve data regarding to a questionnaire of quality of life regarding symptoms of chemotherapy that affects on quality of life perception. The questionnaire has 53 questions and each one has 4 posible answers.	Three months
Secondary	Quality of life of breast cancer patients after a physical therapy rehabilitation program following the surgery.	This outcome will involve data regarding to a questionnaire of quality of life regarding symptoms of chemotherapy that affects on quality of life perception. The questionnaire has 53 questions and each one has 4 posible answers.	Six months