Short and Long Term Effects of a Physical Therapy Program After Breast Cancer Surgery
Primary Purpose
Breast Cancer
Status
Suspended
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Rehabilitation after breast cancer surgery
Sponsored by

About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Upper limb function, Heart hate variability, Physical therapy, Breast neoplasms, Pressure pain threshold, Perceived pain
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.
Sites / Locations
- Catholic University of Maule
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Supervised group
No supervised group
Arm Description
Supervised group
Control group
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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
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
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.
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.
Full Information
NCT ID
NCT04116281
First Posted
September 29, 2019
Last Updated
July 9, 2022
Sponsor
Universidade Federal de Sao Carlos
1. Study Identification
Unique Protocol Identification Number
NCT04116281
Brief Title
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Suspended
Why Stopped
Pandemic situation
Study Start Date
December 2, 2019 (Actual)
Primary Completion Date
May 30, 2020 (Actual)
Study Completion Date
February 25, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Sao Carlos
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Upper limb function, Heart hate variability, Physical therapy, Breast neoplasms, Pressure pain threshold, Perceived pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Supervised group
Arm Type
Experimental
Arm Description
Supervised group
Arm Title
No supervised group
Arm Type
Other
Arm Description
Control group
Intervention Type
Other
Intervention Name(s)
Rehabilitation after breast cancer surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pressure pain threshold over the shoulder of breast cancer patients after a physical therapy rehabilitation program following the surgery.
Description
This outcome will involve data regarding to pressure pain threshold assessment over the shoulder at three and six monthes of treatment.
Time Frame
Three months
Title
Pressure pain threshold over the shoulder of breast cancer patients after a physical therapy rehabilitation program following the surgery.
Description
This outcome will involve data regarding to pressure pain threshold assessment over the shoulder at three and six monthes of treatment.
Time Frame
Six months
Title
Strength grip of breast cancer patients after a physical therapy rehabilitation program following the surgery.
Description
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.
Time Frame
Three months
Title
Strength grip of breast cancer patients after a physical therapy rehabilitation program following the surgery.
Description
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.
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Upper limb functionality of breast cancer patients after a physical therapy rehabilitation program following the surgery.
Description
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.
Time Frame
Three months
Title
Upper limb functionality of breast cancer patients after a physical therapy rehabilitation program following the surgery.
Description
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.
Time Frame
Six months
Title
Fatigue of breast cancer patients after a physical therapy rehabilitation program following the surgery.
Description
This outcome will involve data regarding to a questionnaire wich contains 9 preguntas and 10 differente posibilities of answers.
Time Frame
Three months
Title
Fatigue of breast cancer patients after a physical therapy rehabilitation program following the surgery.
Description
This outcome will involve data regarding to a questionnaire wich contains 9 questions and 10 different posibilities of answers.
Time Frame
Six months
Title
Cardiopulmonary function of breast cancer patients after a physical therapy rehabilitation program following the surgery.
Description
This outcome will involve data regarding to functional capacity performed wiht the walking test measured by the distance performed after a walking.
Time Frame
Three months
Title
Cardiopulmonary function of breast cancer patients after a physical therapy rehabilitation program following the surgery.
Description
This outcome will involve data regarding to functional capacity performed wiht the walking test measured by the distance performed after a walking.
Time Frame
Six months
Title
Cardiopulmonary function of breast cancer patients after a physical therapy rehabilitation program following the surgery.
Description
This outcome will involve data regarding to heart rate variability measured with a Polar and reloj in a supine and orthostatic posture
Time Frame
Three months
Title
Cardiopulmonary function of breast cancer patients after a physical therapy rehabilitation program following the surgery.
Description
This outcome will involve data regarding to heart rate variability measured with a Polar and reloj in a supine and orthostatic posture
Time Frame
Six months
Title
Quality of life of breast cancer patients after a physical therapy rehabilitation program following the surgery.
Description
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.
Time Frame
Three months
Title
Quality of life of breast cancer patients after a physical therapy rehabilitation program following the surgery.
Description
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.
Time Frame
Six months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivana L Ribeiro, PhD
Organizational Affiliation
Universidad Católica del Maule
Official's Role
Principal Investigator
Facility Information:
Facility Name
Catholic University of Maule
City
Talca
State/Province
Maule
ZIP/Postal Code
3600000
Country
Chile
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Short and Long Term Effects of a Physical Therapy Program After Breast Cancer Surgery
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