Use of a Tele-rehabilitation Platform to Enable Physical Activity in Women With Breast Cancer During the Quarantine Period Due to COVID-19.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University of Sao Paulo
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Improvements in heart rate variability indices and rate of perceived exertion after intervention with telerehabilitation.
Study Overview
Brief Summary
Introduction: Cancer is the main public health problem in the world and is already among the main causes of death. Breast CA will be the second most common type of cancer in the Brazilian population between 2020-2022. The pandemic caused by COVID-19 brought several changes in society, affecting health services, one of which was the need to maintain regular treatment for various health conditions, such as cancer. Physical therapy is an essential part of the multidisciplinary treatment of cancer patients. With the new technologies available, it is possible to allow continuous treatment of cancer patients, even during quarantine, and one possibility is the application of information and communication technologies to provide rehabilitation therapy to remote people, called home telerehabilitation. Objective: To verify the effect of virtual reality (VR) training on motor performance, pain and heart rate variability variables in patients diagnosed with breast cancer. Methods: The study will be composed of 30 women over 18 years old with a diagnosis of breast cancer attended at an oncology physical therapy clinic in the city of Juiz de Fora - MG. Participants will undergo training using virtual reality technology, always guided by the researcher. There will be a total of 10 (ten) interventions, with two training sessions per week. The participant will be guided by a researcher who will instruct her online. Five games will be used: Reaction Time, Coincident Timing, Fitts, Genius, MoveHero. Participants will answer some questionnaires and scales such as EORTC QLQ-C30 which assesses quality of life in cancer patients, perceived exertion scale will be applied before and between matches, a mood scale (BRUMS) will be applied at the beginning and at the end of training and Affective Analog Face Scale for pain assessment and analysis of Heart Rate Variability (HRV) that will be performed before, during and after the first and last training, through a heart rate monitor that will be given to each participant and an application cell phone (Elite HRV).
Detailed Description
METHOD
- Study design and location This is a longitudinal study of the randomized clinical trial type. This study will be developed at the Hope Physiotherapy and Esthetics Clinic, headquartered and located in the city of Juiz de Fora, in the state of Minas Gerais.
- Participants Thirty individuals will participate in the study with a diagnosis of breast CA, previously confirmed by a specialist physician, who attend physiotherapy care at the Hope Physiotherapy and Esthetics clinic in the city of Juiz de Fora-MG, authorized by the owner (ANNEX I).
To calculate the sample size, an alpha value (probability of error type 1) of 5% was assumed for the two-tailed hypothesis, beta (probability of error type 2) of 20%, test power of 80% and a difference between groups of 10% referring to engine performance data. Thus, at least 30 individuals will be needed (Dodd et al., 2002).
All participants will be informed about the objectives and procedures of the study and, when they agree, will sign the Informed Consent Form (FICF). The study will be submitted to the Research Ethics Committee (CEP). Resolution 466/2012 of the National Health Council of 10/10/1996 which regulates research involving human beings and the Declaration of Helsinki (1964) will be respected. Data will be electronically stored in databases with restricted and secure access. All data will be encrypted with removal of any information that could identify individuals. 3. Procedures Thirty women diagnosed with breast AC will be selected to analyze the effect on motor performance, pain, perceived exertion and HRV in interventions through VR.
Ten sessions will be applied (two sessions per week). Initially, the researcher will travel to the participant's residence with all the protective equipment necessary for the delivery of the heart rate capture straps, which will be inside a plastic bag disinfected with 70% alcohol and also to present the consent form and clarified to the participants, as well as the procedures and objectives of the study. After signing the consent form, the following information will be collected through online forms: age, gender, corresponding phase (such as chemotherapy, initial diagnosis, complications, relapse diagnosis), length of stay, associated diseases, medications in use, education . Then, the questionnaires will be applied to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), Brunel Mood Scale (BRUMS), BORG scale of perceived exertion, and Analog Affective Faces Scale.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Female patients over 18 years old with a diagnosis of breast AC, who agree to participate in the research and present an understanding compatible with the execution of the procedures, will be invited to participate in the study.
Exclusion Criteria
- •Exclusion criteria will be non-acceptance to participate in the research; presence of neurological diseases (infectious diseases, spinal cord injuries, epilepsy) or orthopedic diseases (orthopedic deformities, muscle strains, sprains, dislocations, fractures and pain conditions) in a period of occurrence; inability to play games on the computer due to motor limitations (fatigue, deformity or muscle weakness), motivational or difficulty in understanding a simple command; metallic skull implants; use of hearing aids; and use of anticonvulsant drugs or muscle relaxants.
Arms & Interventions
Experimental Group
Women with breast cancer who will undergo the intervention with virtual game.
Intervention: Telerehabilitation with virtual game (Other)
Control Group
Healthy women who will undergo the intervention with virtual game.
Intervention: Telerehabilitation with virtual game (Other)
Outcomes
Primary Outcomes
Improvements in heart rate variability indices and rate of perceived exertion after intervention with telerehabilitation.
Time Frame: 5 weeks
Heart rate variability indices measures through a cardiofrequencymeter and rate of perceived exertion through Borg scale before and after 10 session of telerehabilitation.
Secondary Outcomes
- Improvements in quality of life after intervention with telerehabilitation.(5 weeks)
Investigators
Talita Dias da Silva
Researcher
University of Sao Paulo