Movement and Health Beyond Care (MoviS)

Study Overview
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Brief Summary
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MoviS is a randomized controlled trial on the effect of aerobic exercise training on quality of life (QoL) among breast cancer (BC) survivors. Patients randomized to the intervention arm will receive lifestyle recommendations (nutrition and exercise) and will undergo the MoviS Training program, whereas control arm patients will receive lifestyle recommendations. The MoviS Training program consists of 3 months, 3 times per week, aerobic exercise, which will be supervised both directly (2 days each week) and remotely (1 day each week). Exercise intensity (40% to 70% of heart rate reserve) and duration (20 to 60 mins) will be gradually increased throughout the training period. Both arms will receive counseling on psychological well-being. The primary outcome is the improvement of QoL. The secondary outcome is the improvement of the health-related parameters. Study variables will be sampled and compared between and within groups at the baseline, after the 3 month intervention period, ad interim in the short term (6 months) and long term (12 and 24 months).

Detailed Description
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BACKGROUND BC is the most common invasive cancer in women and evidence has shown that exercise can significantly improve the outcomes of BC survivors. MoviS (Movement and Health Beyond Care) is a randomized controlled trial that aims to evaluate the potential health benefits of exercise and proper nutritional habits. Aim The present research study aims to assess the efficacy of aerobic exercise training on the QoL of high-risk BC survivors and the improvement of health-related factors. Methods BC patients (sample size n=172), age 30-70 years, non-metastatic, stage 0-III, non-physically active, 6-12 months post-surgery, and post chemo- or radio-therapy, with a high risk of recurrence defined by one or more of the following criteria: BMI ≥ 25, diagnosis of metabolic syndrome, increased level of blood testosterone and insulin will be randomly allocated to the interventional arm (lifestyle recommendations and MoviS Training) or control arm (lifestyle recommendations). The MoviS Training consists of 3 months of aerobic exercise training (2 d/week of directly supervised and 1 d/week of remotely supervised exercise) with a progressive increase in exercise intensity (40-70% of heart rate reserve) and duration (20-60 min). Both arms will receive counseling on healthy lifestyle habits (nutrition and exercise) based on the World Cancer Research Fund (WCRF) 2018 guidelines through the DIANA-Web platform. All patients will also undergo psychological well-being counseling, which comprises evaluation for anxiety and depression. The primary outcome is the improvement of the QoL assessed by the European Organization for Research and Treatment of Cancer QoL (EORTC QLQ-C30) questionnaire. The secondary outcome is the improvement of health-related parameters such as: fatigue; anthropometric measurements and body composition; cardiac function indexes and heart rate variability; functional parameters (cardiorespiratory fitness, muscle flexibility and strength, coordination and posture variability, upper limb muscle viscoelastic characteristics); psychological well-being; metabolic, hormonal and inflammatory risk factors; gut microbiota; osteoporosis level; recurrences. Diet habits, physical activity level, pharmacological treatments and comorbidity will be recorded as confounding factors and covariates. The hypothesis is that supervised exercise may improve QoL and health-related factors of BC survivors with a high risk of recurrence. Data will be collected at baseline and after the 3 month intervention period, ad interim in the short term (6 months) and long term (12 and 24 months).

Official Title
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Movement and Health Beyond Care, MoviS: Nutrition and Exercise Educational Programs for Breast Cancer Survivors

Conditions
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Breast Cancer Survivors

Intervention / Treatment
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* Behavioral: MoviS Training


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Diagnosis of BC (stage 0-II-III, without metastases or recurrences diagnosis at recruitment). After surgery and chemotherapy and/or radiotherapy treatments. Maximum 12 months from surgical treatment. Minimum 6 months from the end of chemotherapy. Risk of recurrence will be identified with meeting at least 1 of the following criteria: BMI at diagnosis ≥ 25 kg/m2, testosterone ≥ 0.4 ng/mL (for women); serum insulin ≥ 25 µU/mL (170 pmol/L); metabolic syndrome (at least 3 of the following 5 factors): a. glycemia ≥ 100 mg/dL (6.05 mmol/L); b. triglycerides ≥150 mg/dL (1.69 mmol L); c. HDL-C <50 mg/dL (1.29 mmol/L) (woman), <40 mg/dL (1.04 mmol/L) (man); d. waist circumference ≥ 80 cm (woman), ≥ 90 cm (man); e. blood pressure ≥ 130/85 mmHg. Non-physically active: subjects who were not regularly active (assessed by IPAQ) for at least 6 months. Exclusion criteria: Not suitable for non-competitive physical activity after the cardiological medical examination. Disabling pneumological, cardiological, neurological, orthopedic comorbidities and mental illness that prevent the exercise performance. Treatment with drugs that alter the heart rate response to exercise. Treatment with antidepressant drugs.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized to undergo either a lifestyle recommendations and supervised exercise program or only lifestyle recommendations
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional Arm<br>Supervised exercise program: MoviS Training. Lifestyle (nutrition and exercise) counseling based on WCRF 2018 recommendations; psychological well-being counseling which comprises evaluation for anxiety and depression. | Behavioral: MoviS Training<br>* Patients will undergo a supervised exercise program consisting of 3 months of aerobic exercise training (2 d/week of directly supervised exercise and 1 d/week of remotely supervised exercise) with a progressive increase in exercise intensity (40-70% of heart rate reserve) and duration (20-60 min).<br>|
| No Intervention: Control Arm<br>Lifestyle (nutrition and exercise) counseling based on WCRF 2018 recommendations; psychological well-being counseling which comprises evaluation for anxiety and depression. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life assessed by questionnaire | Change in quality of life assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Scores ranging from 0 to 100; higher scores indicate better quality of life. | Baseline - after 3, 6, 12, 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue | Change in fatigue perception assessed by brief fatigue inventory (BFI) questionnaire. The score of the questionnaire ranges from 0 to 90. A higher score means more severe fatigue. | Baseline - after 3, 6, 12, 24 months | 
| Anthropometry | Change body mass index (BMI) expressed as body mass (kg) / height2 (m2). | Baseline - after 3, 6, 12, 24 months | 
| Body composition | Change fat mass (%) assessed by bioelectrical impedance analysis. | Baseline - after 3, 6, 12, 24 months | 
| Cardiac function indexes | Change in the global longitudinal strain (%) assessed by echocardiography. | Baseline - after 3, 6, 12, 24 months | 
| Heart rate variability | Change in heart rate variability assessed by 24-Holter monitoring. | Baseline - after 3 months | 
| Cardiorespiratory fitness | Change in cardiorespiratory fitness assessed by estimated maximal oxygen uptake (mL/min/kg). | Baseline - after 3, 6, 12, 24 months | 
| Flexibility | Change in muscle flexibility assessed by sit & reach test (m). | Baseline - after 3, 6, 12, 24 months | 
| Muscular fitness | Change strength assessed by isometric hand grip strength test (kg). | Baseline - after 3, 6, 12, 24 months | 
| Proprioceptive recalibration | Change assessed by stabilometry (Mean Velocity) (mm2/sec2). | Baseline - after 6 months | 
| Posture balance | Change assessed by stabilometry (Romberg Quotient test-European variant) (% over or under 100). | Baseline - after 6 months | 
| Upper limb muscles viscoelastic characteristics | Change in the muscle properties of the pectoralis major, upper trapezius, and sternoclavicular mastoid muscle assessed by a hand-held myotonometer. | Baseline - after 3 months | 
| Psychological well-being | Change in mood profile assessed by Profile of Mood States (POMS) questionnaire. The POMS questionnaire gives a 5-point Likert scale; a higher score indicates increased negative mood. | Baseline - after 3, 6, 12, 24 months | 
| Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Index | Change in HOMA-IR Index calculated as HOMA-IR = (FPI × FPG)/22.5, where FPI is fasting plasma insulin concentration (mU/l) and FPG is fasting plasma glucose (mmol/L), or as HOMA-IR = (FPI × FPG)/405 if fasting plasma glucose is expressed in mg/dL. | Baseline - after 3, 6, 12, 24 months | 
| Insulin-like growth factor (IGF-1) | Change in IGF-1 assessed by blood samples (µg/L). | Baseline - after 3, 6, 12, 24 months | 
| C-reactive protein | Change in high sensitivity C-reactive protein assessed by blood samples (mg/L). | Baseline - after 3, 6, 12, 24 months | 
| Gut microbiota | Change in microbial diversity (species diversity %) assessed by next-generation sequencing (NGS) of the V3-V4 region of the 16S rDNA gene. | Baseline - after 3, 6, 12, 24 months | 
| Osteoporosis level | Change in computerized bone mineralometry assessed by T-Score (Normal: +2.5> T-score> -1.0; Osteopenia: -1.0> T-score> -2.5; Osteoporosis: T-score <-2.5; Severe osteoporosis: T-score <-2.5 with one or more fragility fractures). | Baseline - after 12 and 24 months | 
| Recurrences | Recurrences free interval defined as time from registration to time of documented recurrent disease. | Baseline - after 3, 6, 12, 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Exercise, Quality of Life