C61
Conditions
Interventions
Group 1: Patients with prostate cancer who undergo 12 weeks of a home-based combined resistance and aerobic training
Group 2: SOC arm (self-directed or no exercise)
Sponsors
LMU Klinikum
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Participant must have a histologically diagnosed adenocarcinoma of the prostate 2. Participant has to be = 18 years of age 3, Participant must have either localized/locally advanced or metastatic PC which has been treated or is planned to be treated either by RP, EBRT, ADT, ARSI, or any combinations 4. Participant must understand and remember the training regiment 5. Participant must have a smartphone to connect a wearable device 6. Participant must have a smartphone or computer to access the study website 7. Participant has to be able to speak, understand and read German or English 8. Participant must sign an informed consent form (ICF)
Exclusion criteria
Exclusion criteria: 1. Cardiovascular/neurological/musculoskeletal comorbidities with contraindications for resistance or aerobic training 2. High risk of pathological fracture due to unstable bone metastases (note: patients with bone metastasis are generally eligible for participation in the study and program as long as there is no acute high risk of fracture) 3. Any condition for which it may not be in the best interest of the patient to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Improvement of Quality of Life (QoL) - Assessment using the following questionnaires: Functional Assessment of Cancer Therapy – Prostate (FACT-P), Expanded Prostate Cancer Index Composite 26 (EPIC-26), Short Form 36 (SF-36), International Index of Erectile Function (IIEF), Pittsburgh Sleep Quality Index (PSQI), Decision Regret Scale, pain assessment using the WHO pain scale, Brief Pain Inventory – Short Form (BPI-SF) - Time points: study enrollment (baseline assessment), after 12 weeks of training, and 3, 6, and 9 months after completion of the training 2. Changes in Body Composition - Assessment using the following parameters: a. Body measurements – weight, height, hip and waist circumference, BMI, waist-to-hip ratio (WHR) b. Muscle thickness measured using ultrasound – vertical distance between the upper and lower fascia of a muscle in the calf muscles c. Physical function – functional tests such as SPPB (Short Physical Performance Battery; consisting of tandem stand, 4-m walk test, and chair stand test), Timed-Up-and-Go Test (TUG Test), handgrip strength using a hand dynamometer - Time points: study enrollment (baseline assessment), after 12 weeks of training 3. Immunological Changes - Assessment using the following immunological biomarkers: CRP, IL-6 - Time points: study enrollment (baseline assessment), after 12 weeks of training, and 3, 6, and 9 months after completion of the training, as well as after 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| - General health assessment (via body measurements and laboratory parameters) - Changes in bone metabolism (via laboratory parameters) - Oncological biomarkers (via PSA measurements/PSA-kinetics) - Physical activity (via PROs and wearable device data) - Adherence to training regimen (via self-report and wearable device data) - Effect of training duration on the efficacy endpoints ( 12 months) - Effect of patient characteristics (e.g., age, previous physical activity, tumor stage, performance status, fitness status) on adherence and primary endpoints | — |
Countries
Germany
Contacts
Public ContactBenazir Enzinger
LMU Klinukum
Outcome results
None listed