MedTrace Logo

Feasibility and Safety of Physical Exercise in Men With Prostate Cancer

NCT04500080 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2022-10-19

No results posted yet for this study

Summary

Prostate cancer (PCa) is among the most widespread in the male population and represents 19% of all cancers diagnosed from the age of fifty, in Italy. Androgen deprivation therapy (ADT) and Radiotherapy (RT) are used for increase survival. However, both therapies are associated with significant side effects, such as fatigue, loss of muscle mass and strength, cognitive decline that together lead to an increase risk of accidental falls and fractures.

Guidelines for cancer survivors recommend Physical Exercise (PE) as a strategy to reduce several side effects of therapies. However, most people living with cancer do not meet current exercise recommendations.

Indeed, an effective PE program requires the application of long-term, moderate to high intensity activity. Thus it may be difficult to implement this type of recommendation in patient with PCa.

Therefore, this study aims to develop an experimental PE intervention testing their feasibility and safety and the patients' satisfaction, aimed at improving the health conditions of the patients with PCa receiving ADT and RT. Furthermore, long-term falls and fracture events will be monitored.

Conditions

Interventions

BEHAVIORAL

PE Intervention

Each single exercise session will last for one hour and will consist of a combination of the following elements: * Aerobic Exercise (AE): 20-30 minutes at moderate-high intensity, from 60 to 80% of the maximum heart rate (% HRmax). * Resistance Exercise (RE): 30 minutes of strength activity of the major muscle groups. * Neuromotor Exercise (NE): will be integrated with strength exercises and will consist of jumping, balance and coordination activities

Sponsors & Collaborators

  • Fondazione Manodori di Reggio Emilia

    collaborator UNKNOWN

  • University of Modena and Reggio Emilia

    collaborator OTHER

  • Azienda USL Reggio Emilia - IRCCS

    lead OTHER_GOV

Principal Investigators

  • Stefania Costi, Ph.D. · Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-14
Primary Completion
2022-01-31
Completion
2022-09-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

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 NCT04500080 on ClinicalTrials.gov