Feasibility and Safety of Physical Exercise in Men With Prostate Cancer (PCa_Ex)

October 17, 2022 updated by: Azienda Unità Sanitaria Locale Reggio Emilia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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, 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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Emilia-Romagna
      • Reggio Emilia, Emilia-Romagna, Italy, 42123
        • Azienda USL-IRCCS Di Reggio Emilia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PE intervention
Aerobic, resistance, and neuromotor exercise
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility - Recruitment rate
Time Frame: At baseline (T0)
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
Time Frame: Throughout the 20 week study period
Determine the percentage of patients adhering to the program and the weekly exercise sessions.
Throughout the 20 week study period
Feasibility - Dropout rate
Time Frame: Throughout the 20 week study period
Percentage of patients that withdraw from the study and the reason to withdraw
Throughout the 20 week study period
Feasibility - Safety/Adverse events
Time Frame: Throughout the 20 week study period
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
Time Frame: Following the study conclusion at 20 weeks.
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
Time Frame: At baseline and 20 weeks.
Lower body muscle strength will be determined with the 10-repetitions maximum test.
At baseline and 20 weeks.
Change of cognitive status assessment
Time Frame: At baseline and 20 weeks.
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
Time Frame: At baseline and 20 weeks.
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
Time Frame: At baseline and 20 weeks.
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
Time Frame: At baseline and 20 weeks.
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
Time Frame: At baseline and 20 weeks.
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.
Time Frame: Throughout the 20 week study period and at one year of follow-up.
Registration of number of falls and fractures events through patient interview.
Throughout the 20 week study period and at one year of follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Unità Sanitaria Locale Reggio Emilia

Collaborators

University of Modena and Reggio Emilia
Fondazione Manodori di Reggio Emilia

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2020

Primary Completion (Actual)

January 31, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

August 1, 2020

First Submitted That Met QC Criteria

August 1, 2020

First Posted (Actual)

August 5, 2020

Study Record Updates

Last Update Posted (Actual)

October 19, 2022

Last Update Submitted That Met QC Criteria

October 17, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 520/2020/SPER/IRCCSRE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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