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Movement and Health Beyond Care (MoviS)

NCT04818359 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2023-11-09

No results posted yet for this study

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 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).

Conditions

  • Breast Cancer Survivors

Interventions

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).

Sponsors & Collaborators

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

    collaborator UNKNOWN

  • National Cancer Institute, Milan

    collaborator OTHER

  • University of Urbino "Carlo Bo"

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-07
Primary Completion
2024-05-31
Completion
2025-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04818359 on ClinicalTrials.gov