Feasibility and Safety of Physical Exercise in Men With Prostate Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Androgen Deprivation Therapy
- Prostate Cancer
- Radiotherapy
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Feasibility pilot studyMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
The non-randomized feasibility and pilot study aims to evaluate the feasibility and safety of a structured, multicomponent, supervised and unsupervised exercise program. Secondary outcome will be evaluate the change in the health condition, in particular muscle strength, cognitive function, fatigue,...
The non-randomized feasibility and pilot study aims to evaluate the feasibility and safety of a structured, multicomponent, supervised and unsupervised exercise program. Secondary outcome will be evaluate the change in the health condition, in particular muscle strength, cognitive function, fatigue, balance, anxiety and depression level, and quality of life. The PE program will be conducted at the "Virgilio Camparada" Municipal Athletic Track in the city of Reggio Emilia (IT). Patients will be participate in a supervised exercise program with three sessions per week, for eight weeks. Subsequently, the intervention will continue further for four weeks maintaining one supervised session and two unsupervised sessions a week. Finally, sessions will be performed without supervision for further eight weeks. The overall duration of the intervention will be twenty weeks. In addition, an evaluation will be performed at one year from baseline to monitor long-term fall and fracture events. At baseline will be the following assessment: - clinical and anthropometric data and the Six Minute Walking Test (6MWT) to determine the intensity of aerobic exercise.
Tracking Information
- NCT #
- NCT04500080
- Collaborators
- Fondazione Manodori di Reggio Emilia
- University of Modena and Reggio Emilia
- Investigators
- Principal Investigator: Stefania Costi, Ph.D. Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia