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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | 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. |
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| Control Group | No Intervention | standard care. Patients in the control group are referred to the municipal standard rehabilitation programs if the patient so wishes. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High intensity high impact exercise intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline, 16 weeks, 32 weeks and 44 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fat free mass (kg) | Measured with DXA scans | Change measures baseline, 32 weeks |
| Body fat (% and kg) | Measured with DXA scans | Change measures baseline, 32 weeks |
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Inclusion Criteria:
Exclusion Criteria:
HIPimmune: all patients included in HIP are eligible for HIPimmune
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne-Mette Ragle, PhD student | Contact | +4527128044 | anne-mette.ragle@regionh.dk | |
| Peter Busch Østergren, MD, PhD | Contact | peter.busch.oestergren@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Anne-Mette Ragle, PhD student | Copenhagen University Hospital at Herlev | Principal Investigator |
| Peter B Østergren | Peter Østergren | Study Director |
| Katharina Leuchte, Dr. med. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev and Gentofte Hospital | Recruiting | Herlev | Herlev | 2730 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40722114 | Derived | Ragle AM, Mikkelsen MK, Vinther A, Zerahn B, Bogh Juhl C, Theile S, Madsen K, Nielsen DL, Ostergren PB. High-intensity resistance and impact training for patients with hormone-sensitive prostate cancer and bone metastases-study protocol of a randomized clinical trial. Trials. 2025 Jul 28;26(1):259. doi: 10.1186/s13063-025-08937-0. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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RCT
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Testers of physical tests (Handgrip strength test and chair-stand-test) and the the statistician will be blinded for allocation.
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| Whole Body (BMC, g) | Measured with DXA scans | Change measures baseline, 32 weeks |
| Whole Body (BMD, g/cm2) | Measured with DXA scans | Change measures baseline, 32 weeks |
| Whole body T-score | Measured with DXA scans | Change measures baseline, 32 weeks |
| Lumbar spine (L1-L4 BMD, g/cm2) | Measured with DXA scans | Change measures baseline, 32 weeks |
| Lumbar spine T-score | Measured with DXA scans | Change measures baseline, 32 weeks |
| Total Hip BMD, g/cm2 | Measured with DXA scans | Change measures baseline, 32 weeks |
| Total hip T-score Os Calcis BMD, g/cm2 Os calcis T-score | Measured with DXA scans | Change measures baseline, 32 weeks |
| Total hip T-score | Measured with DXA scans | Change measures baseline, 32 weeks |
| Os Calcis BMD, g/cm2 | Measured with DXA scans | Change measures baseline, 32 weeks |
| Os calcis T-score | Measured with DXA scans | Change measures baseline, 32 weeks |
| Handgrip strength | Handgrip strength grip test, (measured in Kg, higher score is better outcome) | 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 | 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 | 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. | Through study completion, an average of 1 year |
| Hospitalizations | Registration of hospital admissions in number | Through study completion, an average of 1 year |
| Hospitalizations, causes | Registration of causes for hospital admissions | Through study completion, an average of 1 year |
| Hospitalizations, length of hospitalizations | Registration of hospital admissions in days | 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. | Through study completion, an average of 1 year |
| Feasibility measured by dropout | Feasibility is assessed by dropout in the study | 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 | 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. | 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 | 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 | 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). | Baseline, week 8, week 32, week 44 |
| University Hospital Copenhagen Herlev, National Center for Cancer Immune Therapy (CCIT) |
| Study Director |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D001519 | Behavior |