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

NCT04116281 | Suspended DMC

• 1 other identifier: 154/2019
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Upper limb function; Heart hate variability; Physical therapy; Breast neoplasms; Pressure pain threshold; Perceived pain

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

• Upper limb functionality of breast cancer patients after a physical therapy rehabilitation program following the surgery.

  Three months

• Upper limb functionality of breast cancer patients after a physical therapy rehabilitation program following the surgery.

  Six months

• Fatigue of breast cancer patients after a physical therapy rehabilitation program following the surgery.

  Three months

• Fatigue of breast cancer patients after a physical therapy rehabilitation program following the surgery.

  Six months

• Cardiopulmonary function of breast cancer patients after a physical therapy rehabilitation program following the surgery.

  Three months

Study Arms (2)

Supervised group

EXPERIMENTAL

Supervised group

Other: Rehabilitation after breast cancer surgery

No supervised group

OTHER

Control group

Other: Rehabilitation after breast cancer surgery

Interventions

Rehabilitation after breast cancer surgery OTHER

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.

No supervised group; Supervised group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Sao Carlos: lead

Study Sites (1)

Catholic University of Maule

Talca, Maule Region, 3600000, Chile

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ivana L Ribeiro, PhD

  Universidad Católica del Maule

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel assignment

Study Record Dates

• First Submitted: September 29, 2019
• First Posted: October 4, 2019
• Study Start: December 2, 2019
• Primary Completion: May 30, 2020
• Study Completion: February 25, 2024
• Last Updated: July 12, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share

Locations

CL (1)