Hormone therapy for prostate cancer typically causes significant muscle loss. Skeletal muscle releases Interleukin-7 (IL-7), a signalling protein that supports the production of new immune cells. Therefore, losing muscle during cancer treatment may actively weaken the immune system. The goal of this clinical trial is to investigate if a 12-week supervised resistance exercise (strength training) programme can prevent this muscle loss and increase levels of IL-7. The main questions it aims to answer are: * Does a 12-week strength training programme raise resting IL-7 levels and increase newly formed immune cell counts? * Does a single session of strength training trigger an immediate release of IL-7? * To what extent do exercise-induced improvements in muscle mass and strength translate into reduced fatigue, better physical function, higher quality of life, and improved cardiometabolic health? * Is the exercise programme safe and well-tolerated during hormone therapy? Researchers will compare a Resistance Exercise Group to a Usual Care Group to see the effects of strength training against standard medical care. Participants will: * Attend a screening visit to check eligibility. * Complete baseline assessments, including body composition scans, blood tests, fitness tests, and questionnaires. * Be randomly assigned to either the exercise group or the usual care group. * Complete three supervised strength training sessions per week for 12 weeks, if assigned to the exercise group. * Continue with standard medical care, if assigned to the usual care group. * Repeat all assessments at the end of the 12 weeks. * Perform one short exercise session during the final visit, with extra blood samples taken before and after to track immediate changes
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
40
A 12-week, supervised resistance training programme delivered in small groups in a gym setting. Participants will train 3 times per week on non-consecutive days, with sessions lasting 45-60 minutes. The programme targets all major muscle groups, with volume and intensity gradually increasing throughout the intervention period.
University of Bath
Bath, Somerset, United Kingdom
Change in Resting Interleukin-7 (IL-7) Concentration
Assessed via enzyme-linked immunosorbent assay (ELISA) from resting, fasting blood samples to evaluate changes in baseline immune-supporting signaling proteins.
Time frame: Baseline and 12 weeks
Change in Frequencies of Resting Immune Cell Phenotypes
Assessed via flow cytometry from resting, fasting blood samples to evaluate key immune cell populations, specifically naïve CD4+ T-cells, naïve CD8+ T-cells, and naïve B-cells.
Time frame: Baseline and 12 weeks
Acute Circulating IL-7 Response to a Single Bout of Exercise
Quantified as the incremental Area Under the Curve (iAUC) of circulating IL-7 via ELISA. Blood samples are taken at rest, immediately post-exercise, and 30 minutes post-exercise.
Time frame: Week 12
Change in Total Lean Mass
Measured via Dual-Energy X-ray Absorptiometry (DEXA) to evaluate changes in lean tissue.
Time frame: Baseline and 12 weeks
Change in Total Fat Mass
Measured via Dual-Energy X-ray Absorptiometry (DEXA) to evaluate changes in body fat.
Time frame: Baseline and 12 weeks
Change in Local Muscle Cross-Sectional Area (CSA)
Local muscle cross-sectional area (CSA) assessed via peripheral Quantitative Computed Tomography (pQCT) to assess changes in specific muscle size.
Time frame: Baseline and 12 weeks
Change in Handgrip Strength
Measured using a hand dynamometer to assess upper-body isometric strength
Time frame: Baseline, 12 weeks
Change in 30-Second Sit-to-Stand Test Performance
Evaluated by the number of sit-to-stand repetitions completed in 30 seconds to assess lower-body functional strength.
Time frame: Baseline and 12 weeks
Change in Timed Up and Go (TUG) Test Performance
Assessed using the Timed Up and Go Test (TUG) to evaluate changes in functional mobility and balance.
Time frame: Baseline and 12 weeks
Change in Leg Press Peak Power Output
Assessed using a Keiser leg press to determine peak power output
Time frame: Baseline and 12 weeks
Change in Leg Press One-Repetition Maximum (1RM)
Assessed using a Keiser leg press to determine 1-repetition maximum (1RM).
Time frame: Baseline and 12 weeks
Change in Glycated Haemoglobin (HbA1c)
Analyzed from resting, fasting blood samples to monitor long-term glycemic control.
Time frame: Baseline and 12 weeks
Change in Fasting Insulin
Analyzed from resting, fasting blood samples to evaluate insulin levels and metabolic health
Time frame: Baseline and 12 weeks
Change in Fasting Glucose
Analyzed from resting, fasting blood samples to evaluate baseline glycemic control
Time frame: Baseline and 12 weeks
Change in C-Reactive Protein (CRP)
Analyzed from resting, fasting blood samples to assess baseline systemic inflammation.
Time frame: Baseline and 12 weeks
Change in Cancer-Specific Quality of Life (EORTC QLQ-C30)
Evaluated using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scores range from 0 to 100, where higher scores represent a better quality of life.
Time frame: Baseline and 12 weeks
Change in Prostate Cancer-Specific Symptoms (EORTC QLQ-PR25)
Evaluated using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Prostate Cancer Module (EORTC QLQ-PR25). Scores range from 0 to 100, where higher scores represent higher symptom burden (worse outcome).
Time frame: Baseline and 12 weeks
Change in Fatigue Severity (FACIT-Fatigue)
Evaluated using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) scale. Scores range from 0 to 52, where higher scores represent lower levels of fatigue (better outcome).
Time frame: Baseline and 12 weeks
Uptake and Retention Rates
Uptake is calculated as the percentage of invited eligible patients who consent to participate. Retention is the percentage of randomised participants who successfully complete the final post-intervention assessments.
Time frame: Through study completion
Incidence of Adverse Events
Total number and percentage of participants experiencing adverse events, systematically tracked and evaluated for seriousness and causality.
Time frame: Throughout the 12-week intervention period
Exercise Session Attendance Rate
Calculated as the percentage of the total prescribed supervised exercise sessions successfully attended by the participants in the intervention group.
Time frame: Throughout the 12-week intervention period
Resistance Exercise Dose Adherence
Calculated as the percentage of total prescribed exercise sets completed by the participants in the intervention group
Time frame: Throughout the 12-week intervention period
Average Session Rate of Perceived Exertion (RPE)
Evaluated using the Borg Rating of Perceived Exertion (RPE) Category-Ratio scale (CR10). Scores range from 0 (no exertion at all) to 10 (maximal exertion), recorded at the end of each session and averaged for participants in the intervention group. Higher scores represent a higher perceived physical effort.
Time frame: Throughout the 12-week intervention period
Frequency of Exercise Dose Reductions
Calculated as the percentage of attended exercise sessions where the prescribed volume or intensity had to be modified or reduced due to fatigue or intolerance in the intervention group.
Time frame: Throughout the 12-week intervention period
Frequency of Exercise Interruptions
The total count of instances where a participant in the intervention group missed 3 or more consecutive scheduled exercise sessions.
Time frame: Throughout the 12-week intervention period
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