Movement and Health Beyond Care (MoviS) (MoviS)

November 8, 2023 updated by: Elena Barbieri, University of Urbino "Carlo Bo"

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
172

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
    • PU
      • Urbino, PU, Italy, 61029
        • Presidio Ospedaliero Unico "Santa Maria della Misericordia", Urbino
      • Urbino, PU, Italy, 61029
        • University of Urbino Carlo Bo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  1. Diagnosis of BC (stage 0-II-III, without metastases or recurrences diagnosis at recruitment).
  2. After surgery and chemotherapy and/or radiotherapy treatments.
  3. Maximum 12 months from surgical treatment.
  4. Minimum 6 months from the end of chemotherapy.
  5. 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.
  6. Non-physically active: subjects who were not regularly active (assessed by IPAQ) for at least 6 months.

Exclusion criteria:

  1. Not suitable for non-competitive physical activity after the cardiological medical examination.
  2. Disabling pneumological, cardiological, neurological, orthopedic comorbidities and mental illness that prevent the exercise performance.
  3. Treatment with drugs that alter the heart rate response to exercise.
  4. Treatment with antidepressant drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Interventional Arm
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
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).
No Intervention: Control Arm
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?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Quality of life assessed by questionnaire
Time Frame: Baseline - after 3, 6, 12, 24 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fatigue
Time Frame: Baseline - after 3, 6, 12, 24 months
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
Time Frame: Baseline - after 3, 6, 12, 24 months
Change body mass index (BMI) expressed as body mass (kg) / height2 (m2).
Baseline - after 3, 6, 12, 24 months
Body composition
Time Frame: Baseline - after 3, 6, 12, 24 months
Change fat mass (%) assessed by bioelectrical impedance analysis.
Baseline - after 3, 6, 12, 24 months
Cardiac function indexes
Time Frame: Baseline - after 3, 6, 12, 24 months
Change in the global longitudinal strain (%) assessed by echocardiography.
Baseline - after 3, 6, 12, 24 months
Heart rate variability
Time Frame: Baseline - after 3 months
Change in heart rate variability assessed by 24-Holter monitoring.
Baseline - after 3 months
Cardiorespiratory fitness
Time Frame: Baseline - after 3, 6, 12, 24 months
Change in cardiorespiratory fitness assessed by estimated maximal oxygen uptake (mL/min/kg).
Baseline - after 3, 6, 12, 24 months
Flexibility
Time Frame: Baseline - after 3, 6, 12, 24 months
Change in muscle flexibility assessed by sit & reach test (m).
Baseline - after 3, 6, 12, 24 months
Muscular fitness
Time Frame: Baseline - after 3, 6, 12, 24 months
Change strength assessed by isometric hand grip strength test (kg).
Baseline - after 3, 6, 12, 24 months
Proprioceptive recalibration
Time Frame: Baseline - after 6 months
Change assessed by stabilometry (Mean Velocity) (mm2/sec2).
Baseline - after 6 months
Posture balance
Time Frame: Baseline - after 6 months
Change assessed by stabilometry (Romberg Quotient test-European variant) (% over or under 100).
Baseline - after 6 months
Upper limb muscles viscoelastic characteristics
Time Frame: Baseline - after 3 months
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
Time Frame: Baseline - after 3, 6, 12, 24 months
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
Time Frame: Baseline - after 3, 6, 12, 24 months
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)
Time Frame: Baseline - after 3, 6, 12, 24 months
Change in IGF-1 assessed by blood samples (µg/L).
Baseline - after 3, 6, 12, 24 months
C-reactive protein
Time Frame: Baseline - after 3, 6, 12, 24 months
Change in high sensitivity C-reactive protein assessed by blood samples (mg/L).
Baseline - after 3, 6, 12, 24 months
Gut microbiota
Time Frame: Baseline - after 3, 6, 12, 24 months
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
Time Frame: Baseline - after 12 and 24 months
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
Time Frame: Baseline - after 3, 6, 12, 24 months
Recurrences free interval defined as time from registration to time of documented recurrent disease.
Baseline - after 3, 6, 12, 24 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Diet habits
Time Frame: Baseline - after 3, 6, 12, 24 months
Change in dietary intake assessed by questionnaire (14-item Mediterranean diet adherence screener, MEDIET) through DIANAWeb platform. Higher levels (8-9, or >10 points in the 14-item score) indicates adherence to the Mediterranean diet.
Baseline - after 3, 6, 12, 24 months
Physical activity level
Time Frame: Baseline - after 3, 6, 12, 24 months
Change in physical activity level assessed by the sensewear armband activity monitor and by the international physical activity questionnaire (IPAQ). The output of both assessments expressed in metabolic equivalents (METs)-min/week.
Baseline - after 3, 6, 12, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Urbino "Carlo Bo"

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Presidio Ospedaliero Unico "Santa Maria della Misericordia", Urbino
National Cancer Institute, Milan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 7, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 26, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UniUrb_21/10.07.2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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