Status:
UNKNOWN
Movement and Health Beyond Care (MoviS)
Lead Sponsor:
University of Urbino "Carlo Bo"
Collaborating Sponsors:
Presidio Ospedaliero Unico "Santa Maria della Misericordia", Urbino
National Cancer Institute, Milan
Conditions:
Breast Cancer Survivors
Eligibility:
All Genders
30-70 years
Phase:
NA
Brief 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...
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 rand...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT04818359
Start Date
January 7 2020
End Date
December 31 2025
Last Update
November 9 2023
Active Locations (2)
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1
Presidio Ospedaliero Unico "Santa Maria della Misericordia", Urbino
Urbino, PU, Italy, 61029
2
University of Urbino Carlo Bo
Urbino, PU, Italy, 61029