Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06259279

High Impact Training to Patients with Prostate Cancer and Bone Metastases

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Prostate Cancer Behavior Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Motor Activity Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with metastatic hormone sensitive prostate cancer (mHSPC)
  • Patients must have bone metastases according to the most recent imaging (Bone scan, CT, MRI and/or PET)
  • Patients must be treated with androgen deprivation therapy (ADT) (orchiectomy, luteinizing hormone-releasing hormone (LHRH) agonist or antagonist treatment) started < 12 months ago. Additional treatment in the mHSPC setting, i.e., radiotherapy (RT) of the prostate, novel hormone agents (NHA) and/or docetaxel is permitted
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status score <2
  • Patients must be able to speak and read Danish and provide a signed informed consent form
  • Patients must be ambulatory without walking aids

Exclusion criteria

  • Patients with any physical condition that interferes with the performance of physical exercise training
  • Patients with presence of any musculoskeletal, cardiovascular, or neurologic conditions that may prevent patients from exercising
  • Patients with bone pain requiring opioids
  • Patients with planned or prior palliative radiation therapy to the bone
  • Patients with major surgery within the past 6 months

HIPimmune: all patients included in HIP are eligible for HIPimmune

Treatment and study plan

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.

Primary outcomes

  1. Lower body strength measured with the 30-second chair stand test (30s-CST)

    Time frame: baseline, 16 weeks, 32 weeks and 44 weeks

    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

Secondary outcomes

  1. Fat free mass (kg)

    Time frame: Change measures baseline, 32 weeks

    Measured with DXA scans

  2. Body fat (% and kg)

    Time frame: Change measures baseline, 32 weeks

    Measured with DXA scans

  3. Whole Body (BMC, g)

    Time frame: Change measures baseline, 32 weeks

    Measured with DXA scans

  4. Whole Body (BMD, g/cm2)

    Time frame: Change measures baseline, 32 weeks

    Measured with DXA scans

  5. Whole body T-score

    Time frame: Change measures baseline, 32 weeks

    Measured with DXA scans

  6. Lumbar spine (L1-L4 BMD, g/cm2)

    Time frame: Change measures baseline, 32 weeks

    Measured with DXA scans

  7. Lumbar spine T-score

    Time frame: Change measures baseline, 32 weeks

    Measured with DXA scans

  8. Total Hip BMD, g/cm2

    Time frame: Change measures baseline, 32 weeks

    Measured with DXA scans

  9. Total hip T-score Os Calcis BMD, g/cm2 Os calcis T-score

    Time frame: Change measures baseline, 32 weeks

    Measured with DXA scans

  10. Total hip T-score

    Time frame: Change measures baseline, 32 weeks

    Measured with DXA scans

  11. Os Calcis BMD, g/cm2

    Time frame: Change measures baseline, 32 weeks

    Measured with DXA scans

  12. Os calcis T-score

    Time frame: Change measures baseline, 32 weeks

    Measured with DXA scans

  13. Handgrip strength

    Time frame: baseline, 16 weeks, 32 weeks and 44 weeks

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

  14. Quality of life (QOL)

    Time frame: Change measures baseline, 16 weeks, 32 weeks and 44 weeks

    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

  15. Fatigue

    Time frame: Change measures baseline, 16 weeks, 32 weeks and 44 weeks

    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

  16. Safety (adverse events)

    Time frame: Through study completion, an average of 1 year

    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.

  17. Hospitalizations

    Time frame: Through study completion, an average of 1 year

    Registration of hospital admissions in number

  18. Hospitalizations, causes

    Time frame: Through study completion, an average of 1 year

    Registration of causes for hospital admissions

  19. Hospitalizations, length of hospitalizations

    Time frame: Through study completion, an average of 1 year

    Registration of hospital admissions in days

  20. Falls

    Time frame: Through study completion, an average of 1 year

    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.

  21. Feasibility measured by dropout

    Time frame: Through study completion, an average of 1 year

    Feasibility is assessed by dropout in the study

  22. Feasibility measured by recruitment

    Time frame: Through study completion, an average of 1 year

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

  23. Feasibility measured by adherence.

    Time frame: Through study completion, an average of 1 year

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

  24. Physical activity

    Time frame: Change measures baseline, 16 weeks, 32 weeks and 44 weeks

    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

  25. Qualitative assessment of patients' experiences

    Time frame: Up to 6 months after study completion

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

  26. HIPimmune: Immune response in peripheral blood and tumor

    Time frame: Baseline, week 8, week 32, week 44

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Anne-Mette Ragle, PhD student

CONTACT

[email protected]

+4527128044

Peter Busch Østergren, MD, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Copenhagen University Hospital at Herlev

Other

Registry information

Acronym: HIP

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 14, 2024
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.