The goal of this clinical trial is to evaluate the effects of a newly developed training concept on men with prostate cancer undergoing androgen deprivation therapy (ADT). The main questions it aims to answer are: * How feasible and safe is the new training concept? * How efficient is the training concept to counteract side effects caused by ADT? Researchers will compare the new training concept with usual care to evaluate how efficient the training concept is to counteract the ADT-related side effects. Participants in the intervention group will perform the new training concept twice weekly for 12 weeks. Participants in the control group will only receive usual care. All participants will visit the laboratory at baseline and after 6 and 12 weeks to measure the primary and secondary outcomes.
Detailed description of the training concept applied in the intervention: The two weekly training sessions will be separated by at least two days and supervised by appropriately trained exercise professionals at The Swedish School of Sport and Health Sciences. The training includes a 10 min warm-up followed by 3-4 sets of 8 maximal repetitions on the flywheel machine followed by 16-24, 20 s intervals on a Monark cycle ergometer. The intervals will be performed as 3 blocks with the intention to execute 8 intervals in each block. When a participant manages to perform all 3 blocks with 8 intervals in each block (a total of 24 intervals) the resistance will be increased by \~20 W. The rest period between the intervals will be set to 10 s and the rest between the blocks to 2 min. The starting workload of the intervals will be individually adjusted to \~115 % of the participant's power output at VO2peak. The total duration of a training session will be 30-40 min (including worm-up).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
60
A new training concept is tested on men with prostate cancer receiving androgen deprivation therapy
Swedish School of Sport and Health Sciences
Stockholm, Sweden
RECRUITINGAerobic fitness
VO2peak (ml/kg/min); incremental ramp test on a cycle ergometer
Time frame: Baseline and after 6 and 12 weeks
Maximal leg strength
Isometric squat test (N) measured on force plates
Time frame: Baseline and after 6 and 12 weeks
Body fat
Assessed by dual-energy x-ray absorptiometry (DEXA) (kg)
Time frame: Baseline and after 6 and 12 weeks
Lean body mass
Assessed by dual-energy x-ray absorptiometry (DEXA) (kg)
Time frame: Baseline and after 6 and 12 weeks
Bone mineral density
Assessed by dual-energy x-ray absorptiometry (DEXA) (g/cm2)
Time frame: Baseline and after 6 and 12 weeks
Quadriceps cross-sectional area
Assessed by ultrasound (mm)
Time frame: Baseline and after 6 and 12 weeks
Static balance
One leg balance test on the right and the left foot. Time to first footing is measured and the number of footings during 60s.
Time frame: Baseline and after 6 and 12 weeks
Walk capacity
Usual and fast pace 6m walk test (s)
Time frame: Baseline and after 6 and 12 weeks
Lower body muscular endurance
30 s chair stand test. Maximal number of sit-to-stand repetitions during 30 s.
Time frame: Baseline and after 6 and 12 weeks
Blood pressure
Assessed by an automated blood pressure monitor (mmHg).
Time frame: Baseline and after 6 and 12 weeks
Whole body glucose uptake
Assessed by an oral glucose tolerance test in which the participants will ingest a standardized glucose drink and blood glucose levels will be monitored throughout a period of 2 hours (mmol/L).
Time frame: Baseline and after 6 and 12 weeks
Whole body insulin response
Assessed by an oral glucose tolerance test in which the participants will ingest a standardized glucose drink and blood insulin levels will be monitored throughout a period of 2 hours (μU/mL).
Time frame: Baseline and after 6 and 12 weeks
Blood biomarkers related to cardiovascular disease.
Assessed by high-multiplex immunoassays quantifying proteins associated with biological functions linked to cardiovascular diseases. Approximately 100 proteins will be assessed. Examples of proteins are: C-Reactive Protein (CRP), Tissue Factor (F3), and Thrombomodulin (THBD).
Time frame: Baseline and after 6 and 12 weeks
Muscle fiber cross-sectional area (CSA)
Type I and type II muscle CSA will be assessed by immunohistochemistry (µm2).
Time frame: Baseline and after 12 weeks
Muscle fiber distribution
Type I and type II muscle fiber distribution will be assessed by immunohistochemistry (%).
Time frame: Baseline and after 12 weeks
Capillary content
The number of capillaries per muscle fiber will be assessed by immunohistochemistry.
Time frame: Baseline and after 12 weeks
Myonuclei content
The number of myonuclei per muscle fiber CSA will be assessed by immunohistochemistry.
Time frame: Baseline and after 12 weeks
Satellite cell content
The number of satellite cells per muscle fiber CSA will be assessed by immunohistochemistry.
Time frame: Baseline and after 12 weeks
Mitochondrial content
Mitochondrial content will be assessed by measuring citrate synthase activity in homogenized muscle samples (mmol/kg/dw/min).
Time frame: Baseline and after 12 weeks
Mitochondrial respiration
Mitochondrial respiration will be assessed by respirometry of permeabilized muscle fibers (respiration ratio).
Time frame: Baseline and after 12 weeks
Genome-wide DNA methylation
Assessed by Illumina EPIC arrays to identify epigenetically regulated genes and pathways associated with exercise and the ADT-treatment.
Time frame: Baseline and after 12 weeks
Transcriptome-wide RNA expression
Assessed by RNA-sequencing to identify differently regulated genes and pathways associated with exercise and the ADT-treatment.
Time frame: Baseline and after 12 weeks
Protein expression
Assessed by Western Blot and ELISA (AU). This could for example be proteins related to genes identified by the genome-wide DNA methylation analysis or transcriptome-wide RNA expression analysis.
Time frame: Baseline and after 12 weeks
Gene expression
Assessed by quantitative real-time PCR (AU). This could for example be genes identified by the genome-wide DNA methylation analysis or transcriptome-wide RNA expression analysis.
Time frame: Baseline and after 12 weeks
Cancer treatment-related symptoms
Assessed by the National Prostate Cancer Register (NPCR) form. Scores scaled from 0 to 7. A higher score indicates more severe symptoms.
Time frame: Baseline and after 6 and 12 weeks
Physical activity
Assessed by the physical activity questionnaire. Scores scaled from 1 to 8. A higher score indicates a more physically active participant.
Time frame: Baseline and after 6 and 12 weeks
Physical and psychological health
Assessed by the Short Form Health Survey (SF-36). Scores scaled from 1 to 6. A higher score indicates better physical and psychological health.
Time frame: Baseline and after 6 and 12 weeks
Anxiety and depression
Assessed by the Hospital Anxiety and Depression Scale (HADS). Scores scaled from 0 to 3. A higher score indicates more anxiety and depression.
Time frame: Baseline and after 6 and 12 weeks
Cancer and treatment-related fatigue
Assessed by the Multidimensional Fatigue Inventory survey (MFI-20). Scores scaled from 1 to 5. A higher score indicates more fatigue.
Time frame: Baseline and after 6 and 12 weeks
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