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

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

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.

Study Overview

• Status: Suspended
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Rehabilitation after breast cancer surgery

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Maule
    • Talca, Maule, Chile, 3600000
      • Catholic University of Maule

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supervised group	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.
Other: No supervised group; Control group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Universidade Federal de Sao Carlos
• Investigators: Principal Investigator: Ivana L Ribeiro, PhD, Universidad Católica del Maule

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2019
• Primary Completion (Actual): May 30, 2020
• Study Completion (Anticipated): February 25, 2024

Study Registration Dates

• First Submitted: September 29, 2019
• First Submitted That Met QC Criteria: October 2, 2019
• First Posted (Actual): October 4, 2019

Study Record Updates

• Last Update Posted (Actual): July 12, 2022
• Last Update Submitted That Met QC Criteria: July 9, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Upper limb function; Physical therapy; Breast neoplasms; Pressure pain threshold; Heart hate variability; Perceived pain
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 154/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No