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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06282185
Other study ID # CanisiusWH
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date May 1, 2025

Study information

Verified date February 2024
Source Canisius-Wilhelmina Hospital
Contact stijn Elbers, MD
Phone (+31)243657657
Email s.elbers@cwz.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date May 1, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 85 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Physiotherapy
supervised training program for twelve weeks + usual care + advice about exercise

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Canisius-Wilhelmina Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary change of quality of life assessed with EPIC26 (0-100 points) 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. 6 months
Primary change of quality of life assessed with EPIC26 (0-100 points) 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. 3 months
Primary change of quality of life assessed with EORTC QLQ-C30 (0-100 points per scale) 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. 6 months
Primary change of quality of life assessed with EORTC QLQ-C30 (0-100 points per scale) 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. 3 months
Secondary change of physical fitness in maximum uptake of oxygen in ml/kg/min Assessment of the effectiveness of a supervised training program on cardiopulmonary fitness in patients with metastatic prostate cancer compared to usual care. 6 months
Secondary change of physical fitness in maximum uptake of oxygen in ml/kg/min Assessment of the effectiveness of a supervised training program on cardiopulmonary fitness and body composition in patients with metastatic prostate cancer compared to usual care. 3 months
Secondary change of physical fitness in fat percentage change in body composition in patients with metastatic prostate cancer compared to usual care. 3 months
Secondary change of physical fitness in fat percentage change in body composition in patients with metastatic prostate cancer compared to usual care. 6 months
Secondary change of fitness assessed with IPAQ-sh (categories (1-3) and continues (MET-minutes)) 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: Short Hebrew International Physical Activity Questionnaire (IPAQ-sh). Both categorical and continuous indicators of physical activity will be used from the IPAQ short form. There are three categories:1. inactive, 2. minimally active, 3. HEPA active (health enhancing physical activity; a high active category). The continuous score is reported in median MET-minutes (metabolic equivalent of task-minutes). For categorical and continuous score is a higher score equivalent of higher physical functioning. 3 months
Secondary change of fitness assessed with IPAQ-sh (categories (1-3) and continues (MET-minutes)) 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: Short Hebrew International Physical Activity Questionnaire (IPAQ-sh). Both categorical and continuous indicators of physical activity will be used from the IPAQ short form. There are three categories:1. inactive, 2. minimally active, 3. HEPA active (health enhancing physical activity; a high active category). The continuous score is reported in median MET-minutes (metabolic equivalent of task-minutes). For categorical and continuous score is a higher score equivalent of higher physical functioning. 6 months
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