Prostate CancerHIPNCT06259279
High Impact Training to Patients with Prostate Cancer and Bone Metastases
A study testing High intensity high impact exercise intervention in people with Prostate Cancer, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- High intensity high impact exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteDenmark
- Study dates
- 6 Feb 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Peter Busch Østergren, MD, PhD contact
Denmark1 site, 1 recruiting
- Recruiting
Herlev and Gentofte Hospital
Herlev, Herlev, 2730
Anne-Mette Ragle, PhD student, +4527128044, anne-mette.ragle@regionh.dk
Peter B Østergren, MD PhD, peter.busch.oestergren@regionh.dk
About this study
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).
Read the detailed description
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.
- Conditions
- Prostate Cancer
- Being tested
- High intensity high impact exercise intervention
- Keywords
- bone metastases, exercise, bone mineral density, resistance and impact training, antitumor immunity
- Medical subject headings
- Prostatic Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity high impact exercise interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: High intensity high impact exercise intervention |
| Control Group | No intervention | standard care. Patients in the control group are referred to the municipal standard rehabilitation programs if the patient so wishes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, 16 weeks, 32 weeks and 44 weeks
Secondary outcomes (26)
Fat free mass (kg)
Measured with DXA scans
Measured: Change measures baseline, 32 weeks
Body fat (% and kg)
Measured with DXA scans
Measured: Change measures baseline, 32 weeks
Whole Body (BMC, g)
Measured with DXA scans
Measured: Change measures baseline, 32 weeks
Whole Body (BMD, g/cm2)
Measured with DXA scans
Measured: Change measures baseline, 32 weeks
Whole body T-score
Measured with DXA scans
Measured: Change measures baseline, 32 weeks
Lumbar spine (L1-L4 BMD, g/cm2)
Measured with DXA scans
Measured: Change measures baseline, 32 weeks
Lumbar spine T-score
Measured with DXA scans
Measured: Change measures baseline, 32 weeks
Total Hip BMD, g/cm2
Measured with DXA scans
Measured: Change measures baseline, 32 weeks
Total hip T-score Os Calcis BMD, g/cm2 Os calcis T-score
Measured with DXA scans
Measured: Change measures baseline, 32 weeks
Total hip T-score
Measured with DXA scans
Measured: Change measures baseline, 32 weeks
Os Calcis BMD, g/cm2
Measured with DXA scans
Measured: Change measures baseline, 32 weeks
Os calcis T-score
Measured with DXA scans
Measured: Change measures baseline, 32 weeks
Handgrip strength
Handgrip strength grip test, (measured in Kg, higher score is better outcome)
Measured: 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
Measured: 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
Measured: 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.
Measured: Through study completion, an average of 1 year
Hospitalizations
Registration of hospital admissions in number
Measured: Through study completion, an average of 1 year
Hospitalizations, causes
Registration of causes for hospital admissions
Measured: Through study completion, an average of 1 year
Hospitalizations, length of hospitalizations
Registration of hospital admissions in days
Measured: 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.
Measured: Through study completion, an average of 1 year
Feasibility measured by dropout
Feasibility is assessed by dropout in the study
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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).
Measured: Baseline, week 8, week 32, week 44
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start6 Feb 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne-Mette Ragle, Copenhagen University Hospital at Herlev
- Investigators
- Anne-Mette Ragle, PhD student, Principal investigator, Copenhagen University Hospital at HerlevPeter B Østergren, Study director, Peter ØstergrenKatharina Leuchte, Dr. med., Study director, University Hospital Copenhagen Herlev, National Center for Cancer Immune Therapy (CCIT)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259279
- Sponsor's protocol ID
- AMRagle
- Acronym
- HIP
- Status last verified
- Feb 2025
- First submitted
- 29 Jan 2024
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40722114
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Impact Training to Patients with Prostate Cancer and Bone Metastases
- ClinicalTrials.gov ID
- NCT06259279
- Acronym / sponsor ID
- HIP / AMRagle
- Conditions
- Prostate Cancer
- Keywords
- bone metastases, exercise, bone mineral density, resistance and impact training, antitumor immunity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: High intensity high impact exercise interventionPatients 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. |
| Control Group | No intervention | –standard care. Patients in the control group are referred to the municipal standard rehabilitation programs if the patient so wishes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High intensity high impact exercise interventionPatients 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. | Behavioural | Intervention Group |
Primary outcome
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
26 secondary outcomes
Fat free mass (kg)
Time frame: Change measures baseline, 32 weeks
Body fat (% and kg)
Time frame: Change measures baseline, 32 weeks
Whole Body (BMC, g)
Time frame: Change measures baseline, 32 weeks
Whole Body (BMD, g/cm2)
Time frame: Change measures baseline, 32 weeks
Whole body T-score
Time frame: Change measures baseline, 32 weeks
Lumbar spine (L1-L4 BMD, g/cm2)
Time frame: Change measures baseline, 32 weeks
Lumbar spine T-score
Time frame: Change measures baseline, 32 weeks
Total Hip BMD, g/cm2
Time frame: Change measures baseline, 32 weeks
Total hip T-score Os Calcis BMD, g/cm2 Os calcis T-score
Time frame: Change measures baseline, 32 weeks
Total hip T-score
Time frame: Change measures baseline, 32 weeks
Os Calcis BMD, g/cm2
Time frame: Change measures baseline, 32 weeks
Os calcis T-score
Time frame: Change measures baseline, 32 weeks
Handgrip strength
Time frame: baseline, 16 weeks, 32 weeks and 44 weeks
Quality of life (QOL)
Time frame: Change measures baseline, 16 weeks, 32 weeks and 44 weeks
Fatigue
Time frame: Change measures baseline, 16 weeks, 32 weeks and 44 weeks
Safety (adverse events)
Time frame: Through study completion, an average of 1 year
Hospitalizations
Time frame: Through study completion, an average of 1 year
Hospitalizations, causes
Time frame: Through study completion, an average of 1 year
Hospitalizations, length of hospitalizations
Time frame: Through study completion, an average of 1 year
Falls
Time frame: Through study completion, an average of 1 year
Feasibility measured by dropout
Time frame: Through study completion, an average of 1 year
Feasibility measured by recruitment
Time frame: Through study completion, an average of 1 year
Feasibility measured by adherence.
Time frame: Through study completion, an average of 1 year
Physical activity
Time frame: Change measures baseline, 16 weeks, 32 weeks and 44 weeks
Qualitative assessment of patients' experiences
Time frame: Up to 6 months after study completion
HIPimmune: Immune response in peripheral blood and tumor
Time frame: Baseline, week 8, week 32, week 44
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Derived from this study: PubMed 40722114Ragle 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Busch Østergren, MD, PhD contact
Anne-Mette Ragle, PhD student principal investigator
Copenhagen University Hospital at Herlev
Peter B Østergren study director
Peter Østergren
Katharina Leuchte, Dr. med. study director
University Hospital Copenhagen Herlev, National Center for Cancer Immune Therapy (CCIT)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity high impact exercise intervention in people with Prostate Cancer, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne-Mette Ragle, PhD student (+4527128044, anne-mette.ragle@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower body strength measured with the 30-second chair stand test (30s-CST) (time frame: baseline, 16 weeks, 32 weeks and 44 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06259279, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.