Physical Exercise for Breast Cancer Survivors: Face-to-face Versus Home-based

Associacao de Investigacao de Cuidados de Suporte em Oncologia12 enrolled

Overview

The present investigation is a pilot feasibility study that aims to compare a physical exercise intervention in a face-to-face context (considered state of the art) with a physical exercise intervention in a distance context (online), both supervised, in women, of legal age, physically inactive, breast cancer survivors after primary treatment with curative intent. Before and after the intervention these women will have a physical and functional assessment, as well as a pre-trial cardiopulmonary exercise test, to check if there are safety conditions to participate and also to self tailor the exercise prescription. The prescription follows the ACSM´s exercise guidelines for cancer survivors and will comprise a 8 week combined exercise training, 3 times per week, in which two of them will be supervised and the third session of the week (cardio session) won´t. Chat´s and weekly personal messages, as well as education, will be used to promote retention and exercise adherence.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

Before the intervention, these women will undergo an evaluation of cardiorespiratory fitness, functional fitness, psychological status and a physiatry assessment. A consent form is signed before the start. The physical exercise intervention was planned based on the recommendations of the American College of Sports Medicine for cancer survivors (ACSM 2019), with two supervised combined training sessions (mobility, aerobic training, strength and flexibility training) planned, and one unsupervised aerobic training session per week, interspersed with at least one rest day in between, for 8 weeks. The intensity will be individualized and defined based on the initial assessment. The structure of the training plan was based on the FITT-VP principles (frequency, intensity, time, type, volume and progression) recommended by the ACSM (2019).

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Women * Over legal age * With diagnosis of breast carcinoma between stages 0 and IIIc * ECOG 0 to 1 * Undergoing primary treatment with curative intent (surgery associated or not, with chemotherapy and / or adjuvant radiotherapy) for at least one month * With follow-up on medical oncology consultation at CHVNG/E * With consent of the attending oncologist for the practice of physical exercise * Non-compliance with current physical activity guidelines recommended by the ACSM (moderate aerobic activity\> = 150 min / week or vigorous\> = 75 min / week and \> = 2 strength training sessions / week) * With cognitive capacity to understand the project proposal Exclusion Criteria: * Severe anaemia seen in the last 3 months (Hb \<= 8g / dl) or moderate (Hb\> 8 and \<= 10 g / dl) symptomatic (sustained tachycardia, exertional dyspnea, chest pain or syncope), * Uncontrolled arterial hypertension (HTN grade 3-4 (CTCAE v.5)) (SAD\> = 160mmHg and / or DAD\> = 100mmHg) and / or potentially fatal consequences (malignant HTN, transient or permanent neurological deficit or hypertensive crisis) * Uncontrolled diabetes mellitus * Known cardiac or respiratory pathology * Any other contraindication given by the physiatrist and / or assistant surgeon

Outcomes

Primary Outcomes

Retention rate

The percentage of included patients who ended the program

Time frame: End of the intervention (week 9)

Adherence rate

Number of absences to the sessions and number of completed sessions

Time frame: End of the intervention (week 9)

Training tolerance regarding the duration of the exercise prescription

Recording adherence to the exercise prescription duration, possible adjustments and their reasons

Time frame: During all intervention sessions (24 sessions, 8 weeks)

Training tolerance regarding the intensity of the exercise prescription

Recording adherence to the exercise prescription intensity, possible adjustments and their reasons

Time frame: During all intervention sessions (24 sessions, 8 weeks)

Training tolerance regarding the volume of the exercise prescription

Recording adherence to the exercise prescription volume, possible adjustments and their reasons

Time frame: During all intervention sessions (24 sessions, 8 weeks)

Intervention Recruitment Rate

Number of invitations made versus accepted (invitation made by the assistant oncologist)

Time frame: Beginning of the intervention (week 0)

Training safety

Recording symptoms and adverse effects

Time frame: During all intervention sessions (24 sessions, 8 weeks)

Absence and dropout

Rate of absence from sessions and dropout of the program

Time frame: End of the intervention (week 9)

Level of satisfaction

Questionnaire at the end of the intervention, from 1 to 5, where 1 is not satisfied and 5 is very satisfied

Time frame: End of the intervention (week 9)

Secondary Outcomes

Cardiopulmonary system fitness level and signs of disease assessment

Measurement of maximum VO2 by a cardiopulmonary exercise test and assessment of cardiopulmonary risk factors or disease

Time frame: Beginning of the intervention (week 0)

Lower limb strength

30´´Sit to stand test (number of repetitions)