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

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study of Supervised Adapted Physical Exercise in Women With Breast Cancer After Treatment - Face-to-face Context vs Online Home Based

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Combined exercise training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pilot randomized controlled study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Face-to-Face Group<br>This arm will have a 3 day per week face-to-face participant-tailored combined exercise program, with 2 supervised sessions and 1 non supervised aerobic session, for 8 weeks | Other: Combined exercise training<br>* 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).<br>|
| Experimental: Home-Based Group<br>This arm will have a 3 day per week home-based participant-tailored combined exercise program, with 2 remotely supervised sessions (online) and 1 non supervised aerobic session, for 8 weeks | Other: Combined exercise training<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention rate | The percentage of included patients who ended the program | End of the intervention (week 9) | 
| Adherence rate | Number of absences to the sessions and number of completed sessions | 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 | 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 | 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 | During all intervention sessions (24 sessions, 8 weeks) | 
| Intervention Recruitment Rate | Number of invitations made versus accepted (invitation made by the assistant oncologist) | Beginning of the intervention (week 0) | 
| Training safety | Recording symptoms and adverse effects | During all intervention sessions (24 sessions, 8 weeks) | 
| Absence and dropout | Rate of absence from sessions and dropout of the program | 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 | End of the intervention (week 9) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Beginning of the intervention (week 0) | 
| Lower limb strength | 30´´Sit to stand test (number of repetitions) | Beginning (week 0) and End of the intervention (week 9) | 
| Upper limb strenght | Bilateral handgrip test with dynamometer (kg) | Beginning (week 0) and End of the intervention (week 9) | 
| Lower limbs flexibility level | Sit and Reach test (cm) | Beginning (week 0) and End of the intervention (week 9) | 
| Static balance | One Leg Stance test (time, s) | Beginning (week 0) and End of the intervention (week 9) | 
| Dynamic balance and agility | 8 Foot up and go test (time, s) | Beginning (week 0) and End of the intervention (week 9) | 
| Assessment of aerobic capacity | 6 Minute Walk Test | Beginning (week 0) and End of the intervention (week 9) | 
| Safety of the intervention | Number of serious and less serious occurrences | During all intervention sessions (24 sessions, 8 weeks) | 
| Body weight | Weight (Kg) | Beginning (week 0) and End of the intervention (week 9) | 
| Body height | Height (m) | Beginning (week 0) and End of the intervention (week 9) | 
| Body circumferences | Waist circumference (cm), hip circumference (cm), middle crural circumference (cm) and bicipital circumference (cm) | Beginning (week 0) and End of the intervention (week 9) | 
| Individual's overall satisfaction with life and general sense of personal well-being | Questionnaire QLQ-C30 | Beginning (week 0) and End of the intervention (week 9) | 
| Individual's overall satisfaction with life and general sense of personal well-being, specific to breast cancer patient | Questionnaire QLQ-BR23 | Beginning (week 0) and End of the intervention (week 9) | 
| Adverse effects | Common Terminology Criteria for Adverse Effects, version 5, scale (presence of fatigue, osteoarticular and cardiac complaints, pain, neuropathy and lymphedema), ranging from 1 (mild, asymptomatic ou mild symptoms) to 5 (dead related to adverse event) | During all intervention sessions (24 sessions, 8 weeks) | 
| Assessment of performance status | ECOG scale of performance status, in a scale ranging from 0 (fully active, able to carry same activities as before disease without new restrictions) to 5 (dead) | During all intervention sessions (24 sessions, 8 weeks) | 
| Heart Function | Resting heart rate (bpm) | Beginning of the intervention (week 0) | 
| Arterial disorder assessment | Systolic and diastolic blood pressure assessment (mm/hg) | Beginning of the intervention (week 0) | 
| Physical activity and sedentary behaviors | Accelerometry | Beginning (week 0) and End of the intervention (week 9) | 
| Subjective perception of effort | Borg scale of perceived exertion ranging from 6 (very, very light effort) to 20 (maximum exertion) | During all intervention sessions (24 sessions, 8 weeks) |