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Breast Cancer SurvivorsMoviSNCT04818359

Movement and Health Beyond Care (MoviS)

A study testing MoviS Training in people with Breast Cancer Survivors, run by University of Urbino "Carlo Bo" at 2 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 30 to 70 years
Conditions the study is for
Breast Cancer Survivors
What is being tested?
MoviS Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
172 participants
Where
2 sitesItaly
Study dates
7 Jan 2020to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

  • Presidio Ospedaliero Unico "Santa Maria della Misericordia", Urbino

    Urbino, PU, 61029

  • University of Urbino Carlo Bo

    Urbino, PU, 61029

Other trials in Italy

About this study

Official title: 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.

Read more

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).

Read the 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).

Being tested
MoviS Training
Keywords
Breast Cancer, Exercise, Quality of Life
Medical subject headings
Breast Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MoviS TrainingBehavioural

    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).

Study groups in NCT04818359
Study groupRoleWhat they receive
Interventional ArmExperimentalSupervised 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.
Receives: Behavioral: MoviS Training
Control ArmNo interventionLifestyle (nutrition and exercise) counseling based on WCRF 2018 recommendations; psychological well-being counseling which comprises evaluation for anxiety and depression.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline - after 3, 6, 12, 24 months

Secondary outcomes (18)

  1. 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.

    Measured: Baseline - after 3, 6, 12, 24 months

  2. Anthropometry

    Change body mass index (BMI) expressed as body mass (kg) / height2 (m2).

    Measured: Baseline - after 3, 6, 12, 24 months

  3. Body composition

    Change fat mass (%) assessed by bioelectrical impedance analysis.

    Measured: Baseline - after 3, 6, 12, 24 months

  4. Cardiac function indexes

    Change in the global longitudinal strain (%) assessed by echocardiography.

    Measured: Baseline - after 3, 6, 12, 24 months

  5. Heart rate variability

    Change in heart rate variability assessed by 24-Holter monitoring.

    Measured: Baseline - after 3 months

  6. Cardiorespiratory fitness

    Change in cardiorespiratory fitness assessed by estimated maximal oxygen uptake (mL/min/kg).

    Measured: Baseline - after 3, 6, 12, 24 months

  7. Flexibility

    Change in muscle flexibility assessed by sit \& reach test (m).

    Measured: Baseline - after 3, 6, 12, 24 months

  8. Muscular fitness

    Change strength assessed by isometric hand grip strength test (kg).

    Measured: Baseline - after 3, 6, 12, 24 months

  9. Proprioceptive recalibration

    Change assessed by stabilometry (Mean Velocity) (mm2/sec2).

    Measured: Baseline - after 6 months

  10. Posture balance

    Change assessed by stabilometry (Romberg Quotient test-European variant) (% over or under 100).

    Measured: Baseline - after 6 months

  11. 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.

    Measured: Baseline - after 3 months

  12. 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.

    Measured: Baseline - after 3, 6, 12, 24 months

  13. 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.

    Measured: Baseline - after 3, 6, 12, 24 months

  14. Insulin-like growth factor (IGF-1)

    Change in IGF-1 assessed by blood samples (µg/L).

    Measured: Baseline - after 3, 6, 12, 24 months

  15. C-reactive protein

    Change in high sensitivity C-reactive protein assessed by blood samples (mg/L).

    Measured: Baseline - after 3, 6, 12, 24 months

  16. Gut microbiota

    Change in microbial diversity (species diversity %) assessed by next-generation sequencing (NGS) of the V3-V4 region of the 16S rDNA gene.

    Measured: Baseline - after 3, 6, 12, 24 months

  17. 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).

    Measured: Baseline - after 12 and 24 months

  18. Recurrences

    Recurrences free interval defined as time from registration to time of documented recurrent disease.

    Measured: Baseline - after 3, 6, 12, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2021
  2. Study start7 Jan 2020
  3. Primary completion31 May 2024 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized to undergo either a lifestyle recommendations and supervised exercise program or only lifestyle recommendations
Masking
None (open label)
Enrolment
172 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04818359
Sponsor's protocol ID
UniUrb_21/10.07.2019
Acronym
MoviS
Status last verified
Nov 2023
First submitted
22 Feb 2021
Last updated
9 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Annibalini G, Sisti D, De Santi M, Natalucci V, Imperio M, Ferri Marini C, Lucertini F, Vallorani L, Saltarelli R, Baldelli G, Barocci S, Flori M, Catalano V, Rocchi MBL, Villarini A, Emili R, Barbieri E. Lifestyle intervention based on aerobic exercise and Mediterranean diet modulates IGF-1 and its binding proteins in breast cancer survivors. Breast Cancer Res. 2026 Mar 27;28(1):81. doi: 10.1186/s13058-026-02262-3.

    PubMed 41896896

  • Wang K, Shen Y, Hu C, Xu F, Wang Q, Gao Y, Zhou L. Population Pharmacokinetics and Exposure-Response Analysis of Serplulimab in Small Cell Lung Cancer Patients. Clin Transl Sci. 2025 Sep;18(9):e70322. doi: 10.1111/cts.70322.

    PubMed 40932107

  • Donati Zeppa S, Natalucci V, Agostini D, Vallorani L, Amatori S, Sisti D, Rocchi MBL, Pazienza V, Perri F, Villani A, Binda E, Panebianco C, Mencarelli G, Ciuffreda L, Ferri Marini C, Annibalini G, Lucertini F, Bartolacci A, Imperio M, Virgili E, Catalano V, Piccoli G, Stocchi V, Emili R, Barbieri E. Changes in gut microbiota composition after 12 weeks of a home-based lifestyle intervention in breast cancer survivors during the COVID-19 lockdown. Front Oncol. 2023 Sep 1;13:1225645. doi: 10.3389/fonc.2023.1225645. eCollection 2023.

    PubMed 37727203

  • Natalucci V, Ferri Marini C, De Santi M, Annibalini G, Lucertini F, Vallorani L, Panico AR, Sisti D, Saltarelli R, Donati Zeppa S, Agostini D, Gervasi M, Baldelli G, Grassi E, Nart A, Rossato M, Biancalana V, Piccoli G, Benelli P, Villarini A, Somaini M, Catalano V, Guarino S, Pietrelli A, Monaldi S, Sarti D, Barocci S, Flori M, Rocchi MBL, Brandi G, Stocchi V, Emili R, Barbieri E. Movement and health beyond care, MoviS: study protocol for a randomized clinical trial on nutrition and exercise educational programs for breast cancer survivors. Trials. 2023 Feb 22;24(1):134. doi: 10.1186/s13063-023-07153-y.

    PubMed 36814313

Questions about this trial

What is this clinical trial studying?

A study testing MoviS Training in people with Breast Cancer Survivors, run by University of Urbino "Carlo Bo" at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of life assessed by questionnaire (time frame: Baseline - after 3, 6, 12, 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04818359, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.

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