An interventional study of High intensity high impact exercise intervention in Prostate Cancer, sponsored by Copenhagen University Hospital at Herlev. Recruiting at 1 site in Denmark. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-13.
Sponsored by Copenhagen University Hospital at Herlev · Not applicable, Interventional, and Supportive care
HIP is a randomized controlled trial. The aim is investigate the effect, safety and feasibility of brief, high-impact exercise targeting bones in patients with prostate cancer and bone metastases. Furthermore, to investigate the effects of the intervention on bone status (bone mineral density) and body composition, physical function and performance, patient reported quality-of-life outcomes, falls and hospitalizations. The effects of resistance training on the antitumor immunity will be assessed in the peripheral blood and tumor biopsies (HIPimmune).
Participants assigned to the intervention group will participate in a 32-week, twice-weekly, 30-minute, supervised HIP program at the hospital in Herlev, Denmark. To ensure a safe transition to high-intensity exercise, the first eight weeks of the intervention includes self-bodyweight and low-impact variations with a focus on getting used to use weight training equipment and gradually learning the movement patterns of the HIP exercises. All participants should be able to perform the four basic exercises of the intervention within two months. The resistance exercises (deadlift, overhead press, and squats) will be performed in five sets of five repetitions for the remaining intervention period, maintaining an intensity of > 80% to 85% of 1 repetition maximum (RM). Blood samples and tumor biopsies will be taken at different timepoints of the exercise intervention (HIPimmune) and analyzed for lymphocyte entitumor responses.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 102 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Copenhagen University Hospital at Herlev is the lead sponsor of 77 studies on the registry; 9 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
HIPimmune: all patients included in HIP are eligible for HIPimmune
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in the intervention group will receive a 32-week exercise-based intervention that includes supervised and group-based exercise training in the hospital, twice a week. Each session lasts approximately 30 minutes.
Behavioral: High intensity high impact exercise intervention
standard care. Patients in the control group are referred to the municipal standard rehabilitation programs if the patient so wishes.
Patients in the intervention group will receive a 32-week exercise-based intervention that includes: - Supervised and group-based exercise training in the hospital, twice a week. Each session lasts approximately 30 minutes.
Lower body strength measured with the 30-second chair stand test (30s-CST)
Number of stands a participant can complete in 30-seconds from a seated position with their arms crossed over the chest. The assesment will be conducted by blinded physiotherapist
Time frame: baseline, 16 weeks, 32 weeks and 44 weeks
Fat free mass (kg)
Measured with DXA scans
Time frame: Change measures baseline, 32 weeks
Body fat (% and kg)
Measured with DXA scans
Time frame: Change measures baseline, 32 weeks
Whole Body (BMC, g)
Measured with DXA scans
Time frame: Change measures baseline, 32 weeks
Whole Body (BMD, g/cm2)
Measured with DXA scans
Time frame: Change measures baseline, 32 weeks
Whole body T-score
Measured with DXA scans
Time frame: Change measures baseline, 32 weeks
Lumbar spine (L1-L4 BMD, g/cm2)
Measured with DXA scans
Time frame: Change measures baseline, 32 weeks
Lumbar spine T-score
Measured with DXA scans
Time frame: Change measures baseline, 32 weeks
Total Hip BMD, g/cm2
Measured with DXA scans
Time frame: Change measures baseline, 32 weeks
Total hip T-score Os Calcis BMD, g/cm2 Os calcis T-score
Measured with DXA scans
Time frame: Change measures baseline, 32 weeks
Total hip T-score
Measured with DXA scans
Time frame: Change measures baseline, 32 weeks
Os Calcis BMD, g/cm2
Measured with DXA scans
Time frame: Change measures baseline, 32 weeks
Os calcis T-score
Measured with DXA scans
Time frame: Change measures baseline, 32 weeks
Handgrip strength
Handgrip strength grip test, (measured in Kg, higher score is better outcome)
Time frame: baseline, 16 weeks, 32 weeks and 44 weeks
Quality of life (QOL)
Measured with the Functional Assessment of Cancer Therapy-Prostate. the questionnaire is divided into several sub-topics, and it differs from topic to topic whether a high score is best. Minimum score:0 and maximum score 4
Time frame: Change measures baseline, 16 weeks, 32 weeks and 44 weeks
Fatigue
Measured with the Functional Assessment of Chronic Illness Therapy - Fatigue Scale. Low score is a better outcome the minimum score is 0, maximum score is 4
Time frame: Change measures baseline, 16 weeks, 32 weeks and 44 weeks
Safety (adverse events)
Safety is measured by registration of bone fracture grade \> 2 according to Common Terminology Criteria for Adverse Events (CTCAE) grading criteria. Adverse events as musculoskeletal grade \> 2 including pain, or cardiac disorders according to CTCAE, and sprains requiring medical treatment. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age, appropriate instrumental ADL\*. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL\*\*. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Time frame: Through study completion, an average of 1 year
Hospitalizations
Registration of hospital admissions in number
Time frame: Through study completion, an average of 1 year
Hospitalizations, causes
Registration of causes for hospital admissions
Time frame: Through study completion, an average of 1 year
Hospitalizations, length of hospitalizations
Registration of hospital admissions in days
Time frame: Through study completion, an average of 1 year
Falls
Participants will be asked to report incidence of any falls in the project period . Falls requiring treatment will be registered as adverse events and be reported according to CTCAE.
Time frame: Through study completion, an average of 1 year
Feasibility measured by dropout
Feasibility is assessed by dropout in the study
Time frame: Through study completion, an average of 1 year
Feasibility measured by recruitment
Feasibility is assessed by recruitment, numbers of included patients compared to number of eligible patients
Time frame: Through study completion, an average of 1 year
Feasibility measured by adherence.
Feasibility is assessed by adherence. How many times the patients participate in the execise sessions . Numbers from 0-64. Higher score is better.
Time frame: Through study completion, an average of 1 year
Physical activity
Data of daily physical activity will be assessed in the intervention period using the Physical Activity Scale 2 (PAS -2), which measure physical activity levels
Time frame: Change measures baseline, 16 weeks, 32 weeks and 44 weeks
Qualitative assessment of patients' experiences
Qualitative individual semi-structured interviews with participants from the intervention group
Time frame: Up to 6 months after study completion
HIPimmune: Immune response in peripheral blood and tumor
Flow-cytometric analysis of circulating immune cell frequencies (T, B, NK cells and myeloid cells) longitudinally during the study period, both before and after the exercise intervention (in the intervention arm). Additionally, prostate biopsies around week 32 will be stained by immunohistochemistry for infiltrating immune cells (T and NK cells).
Time frame: Baseline, week 8, week 32, week 44
Started Feb 2024 (actual). Primary completion is estimated for Dec 2026, 34 months after the start.
Of 1,098 non-industry interventional studies with no phase under Prostatic Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 86. This study's planned 34 months is below that.
Counting every sponsor, half of 1,155 studies reached it within 43 months; a quarter within 22 and three quarters within 84.
How these figures are worked out, and which studies are left out of them.
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Copenhagen University Hospital at Herlev