Swedish School of Sport and Health Sciences
Stockholm, 11486, Sweden
Location status: Recruiting
Location contact
Niklas Psilander, PhD
CONTACT
Niklas Psilander, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06449664
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.
Interested in participating?
Request Info50 year–80 year
Male
Interventional
Not applicable
Stockholm, 11486, Sweden
Location status: Recruiting
Niklas Psilander, PhD
CONTACT
Niklas Psilander, PhD
PRINCIPAL_INVESTIGATOR
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A new training concept is tested on men with prostate cancer receiving androgen deprivation therapy
Time frame: Baseline and after 6 and 12 weeks
VO2peak (ml/kg/min); incremental ramp test on a cycle ergometer
Time frame: Baseline and after 6 and 12 weeks
Isometric squat test (N) measured on force plates
Time frame: Baseline and after 6 and 12 weeks
Assessed by dual-energy x-ray absorptiometry (DEXA) (kg)
Time frame: Baseline and after 6 and 12 weeks
Assessed by dual-energy x-ray absorptiometry (DEXA) (kg)
Time frame: Baseline and after 6 and 12 weeks
Assessed by dual-energy x-ray absorptiometry (DEXA) (g/cm2)
Time frame: Baseline and after 6 and 12 weeks
Assessed by ultrasound (mm)
Time frame: Baseline and after 6 and 12 weeks
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
Usual and fast pace 6m walk test (s)
Time frame: Baseline and after 6 and 12 weeks
30 s chair stand test. Maximal number of sit-to-stand repetitions during 30 s.
Time frame: Baseline and after 6 and 12 weeks
Assessed by an automated blood pressure monitor (mmHg).
Time frame: Baseline and after 6 and 12 weeks
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
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
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 12 weeks
Type I and type II muscle CSA will be assessed by immunohistochemistry (µm2).
Time frame: Baseline and after 12 weeks
Type I and type II muscle fiber distribution will be assessed by immunohistochemistry (%).
Time frame: Baseline and after 12 weeks
The number of capillaries per muscle fiber will be assessed by immunohistochemistry.
Time frame: Baseline and after 12 weeks
The number of myonuclei per muscle fiber CSA will be assessed by immunohistochemistry.
Time frame: Baseline and after 12 weeks
The number of satellite cells per muscle fiber CSA will be assessed by immunohistochemistry.
Time frame: Baseline and after 12 weeks
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 will be assessed by respirometry of permeabilized muscle fibers (respiration ratio).
Time frame: Baseline and after 12 weeks
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
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
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
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 6 and 12 weeks
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
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
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
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
Assessed by the Multidimensional Fatigue Inventory survey (MFI-20). Scores scaled from 1 to 5. A higher score indicates more fatigue.
Contact information is provided by the study sponsor or research team.
The Swedish School of Sport and Health Sciences
Other
ADT-Train - A New Training Concept for Men With Prostate Cancer Receiving Androgen Deprivation Therapy.
Acronym: ADT-train
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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