SUPERvised Three-month Exercise Program in MEN With Prostate cAncer Receiving Androgen-deprivaTioN thERapy
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Prostatic Neoplasms
- Sponsor
- Canisius-Wilhelmina Hospital
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- change of quality of life assessed with EPIC26 (0-100 points)
- Status
- Withdrawn
- Last Updated
- last month
Overview
Brief Summary
The goal of this single blind placebo-controlled intervention study is to examine the impact of a supervised training program on disease-related quality of life and physical fitness in patient with advanced prostate cancer compared to usual care. The main question[s] it aims to answer are:
- What is the impact of exercise on quality of life
- What is the impact of exercise on physical fitness
Participants will have an individual training program with supervised training by physiotherapists.
Researchers will compare with usual care to see if advice about exercise has significant less effect than an supervised training program.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed informed consent
- •Age \> 18 years old
- •Able to read and complete questionnaires in Dutch
- •Proven histologically and /or radiologically metastatic prostate cancer (TxNxM1)
Exclusion Criteria
- •Other cancers
- •Clinicians' judgement
- •Age \>80 years old or not able to walk 400m
- •Structural exercise (moderate-intensity exercise more than 150 minutes a week) during the past 3 months
- •Musculoskeletal, cardiovascular, or neurological disorders that could inhibit them from exercising
- •Spinal cord compression, history of pathological fractures
Outcomes
Primary Outcomes
change of quality of life assessed with EPIC26 (0-100 points)
Time Frame: 3 months
To examine the impact of a supervised training program on disease-related quality of life in patient with advanced prostate cancer compared to usual care. The following questionnaire is used: Expanded Prostate Cancer Index Composite (EPIC26). With higher scores representing better disease-related quality of life.
change of quality of life assessed with EORTC QLQ-C30 (0-100 points per scale)
Time Frame: 3 months
To examine the impact of a supervised training program on disease-related quality of life in patient with advanced prostate cancer compared to usual care. The following questionnaires are used: European Organization for Research and Treatment for Cancer Quality of Life Questionnaire (EORTC QLQ-C30). A higher score represents a higher response level. So a higher score for the functional scale represents a higher level of physical functioning but a higher score for the symptoms scale represents a higher level of symptoms.
change of quality of life assessed with EPIC26 (0-100 points)
Time Frame: 6 months
To examine the impact of a supervised training program on disease-related quality of life in patient with advanced prostate cancer compared to usual care. The following questionnaire is used: Expanded Prostate Cancer Index Composite (EPIC26). With higher scores representing better disease-related quality of life.
change of quality of life assessed with EORTC QLQ-C30 (0-100 points per scale)
Time Frame: 6 months
To examine the impact of a supervised training program on disease-related quality of life in patient with advanced prostate cancer compared to usual care. The following questionnaires are used: European Organization for Research and Treatment for Cancer Quality of Life Questionnaire (EORTC QLQ-C30). A higher score represents a higher response level. So a higher score for the functional scale represents a higher level of physical functioning but a higher score for the symptoms scale represents a higher level of symptoms.
Secondary Outcomes
- change of physical fitness in fat percentage(6 months)
- change of physical fitness in maximum uptake of oxygen in ml/kg/min(3 months)
- change of fitness assessed with IPAQ-sh (categories (1-3) and continues (MET-minutes))(6 months)
- change of physical fitness in maximum uptake of oxygen in ml/kg/min(6 months)
- change of physical fitness in fat percentage(3 months)
- change of fitness assessed with IPAQ-sh (categories (1-3) and continues (MET-minutes))(3 months)