Feasibility and Safety of Physical Exercise in Men With Prostate Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Feasibility and Safety of Physical Exercise Program in Men With Prostate Cancer Receiving Androgen Deprivation Therapy and Radiotherapy

Conditions
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Prostate Cancer, Androgen Deprivation Therapy, Radiotherapy

Intervention / Treatment
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* Behavioral: PE Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically documented diagnosis of PCa; Undergo ADT and RT during the study period; At least 18 years old; Willing and able to give written informed consent; Able to read and understand Italian Language; Exclusion Criteria: Musculoskeletal, cardiovascular, neurological or psychiatric disorders that contraindicate participation in an exercise program.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Feasibility pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PE intervention<br>Aerobic, resistance, and neuromotor exercise | Behavioral: PE Intervention<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility - Recruitment rate | Percentage ratio between patients included in the study and number of participants screened for recruitment. | At baseline (T0) | 
| Feasibility - Adherence rate to the exercise program | Determine the percentage of patients adhering to the program and the weekly exercise sessions. | Throughout the 20 week study period | 
| Feasibility - Dropout rate | Percentage of patients that withdraw from the study and the reason to withdraw | Throughout the 20 week study period | 
| Feasibility - Safety/Adverse events | Any adverse events, related or not related to the exercise program, will be documented | Throughout the 20 week study period | 
| Feasibility - Compliance and patients' experience | Determined by qualitative evaluation, using interviews, to assess experiences, accessibility and acceptability of the exercise intervention. | Following the study conclusion at 20 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of muscular strength assessment | Lower body muscle strength will be determined with the 10-repetitions maximum test. | At baseline and 20 weeks. | 
| Change of cognitive status assessment | Cognitive status will be assess using the Mini Mental State Examination (MMSE), a 30-point questionnaire italian version. A score of 24 or more (out of 30) indicates a normal cognition. | At baseline and 20 weeks. | 
| Change of fatigue assessment | Fatigue will be measured using the Fatigue Severity Scale (FSS). FSS is a 9-item questionnaire on how fatigue interferes activities and rates its severity. The item are scored on a 7 point scale with 1 = strongly disagree and 7 = strongly agree. The minimum score = 9, maximum score = 63. Higher score means greater fatigue severity. | At baseline and 20 weeks. | 
| Change of fall risk assessment | Fall risk will be assessed using the Tinetti Performance Oriented Mobility Assessment (POMA). The Tinetti POMA is a clinical test used to measure balance and gait abilities. The balance section (POMA-B) consists of 9 items while the gait section (POMA-G) consists of 8 items.Each of these items has answer choices that are weighted on an ordinal scale from 0 to 1 or 2. 0 indicates the highest level of impairment and 2 the individuals independence. The maximum possible total score for POMA-T is 28, for POMA-B is 16, and for POMA-G is 12. | At baseline and 20 weeks. | 
| Change of anxiety and depression level | Depression and anxiety level will be measured using the Hospital Anxiety and Depression Scale (HADS). The HADS is a fourteen item scale, seven relate to anxiety and seven relate to depression. The total score goes from 0-21. Higher total scores indicate greater levels of depression. | At baseline and 20 weeks. | 
| Change of quality of life assessment | Quality of life will be measured by a Short form-12 questionnaire (SF-12). The SF-12 is a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. Higher scores indicate a better physical and mental health. | At baseline and 20 weeks. | 
| Falls and fractures. | Registration of number of falls and fractures events through patient interview. | Throughout the 20 week study period and at one year of follow-up. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Feasibility, Safety