Neoplasms

Symptoms and General Pathology

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasm Metastasis

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Neoplastic Processes

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.

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.

High intensity high impact exercise intervention

Anne-Mette Ragle, PhD student

Peter Busch Østergren, MD, PhD

Peter B Østergren, MD PhD

Peter B Østergren

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.

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).

Testers of physical tests (Handgrip strength test and chair-stand-test) and the the statistician will be blinded for allocation.

High Impact Training to Patients With Prostate Cancer and Bone Metastases

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

Handgrip strength grip test, (measured in Kg, higher score is better outcome)

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

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

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.

Registration of hospital admissions in number

Registration of causes for hospital admissions

Registration of hospital admissions in days

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.

Feasibility is assessed by dropout in the study

Feasibility is assessed by recruitment, numbers of included patients compared to number of eligible patients

Feasibility is assessed by adherence. How many times the patients participate in the execise sessions . Numbers from 0-64. Higher score is better.

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

Qualitative individual semi-structured interviews with participants from the intervention group

Spots Global Cancer Trial Database for resistance and impact training