High Impact Training to Patients with Prostate Cancer and Bone Metastases

NCT06259279 | Recruiting

• 1 other identifier: AMRagle
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Prostate Cancer

Keywords

bone metastases; exercise; bone mineral density; resistance and impact training; antitumor immunity

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (26)

• Fat free mass (kg)

  Change measures baseline, 32 weeks

• Body fat (% and kg)

  Change measures baseline, 32 weeks

• Whole Body (BMC, g)

  Change measures baseline, 32 weeks

• Whole Body (BMD, g/cm2)

  Change measures baseline, 32 weeks

• Whole body T-score

  Change measures baseline, 32 weeks

Study Arms (2)

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.

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.

Interventions

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Copenhagen University Hospital at Herlev: lead

Study Sites (1)

Herlev and Gentofte Hospital

Herlev, Herlev, 2730, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 40722114 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Behavior

Study Officials

• Anne-Mette Ragle, PhD student

  Copenhagen University Hospital at Herlev

  PRINCIPAL INVESTIGATOR

• Peter B Østergren

  Peter Østergren

  STUDY DIRECTOR

• Katharina Leuchte, Dr. med.

  University Hospital Copenhagen Herlev, National Center for Cancer Immune Therapy (CCIT)

  STUDY DIRECTOR

Central Study Contacts

Anne-Mette Ragle, PhD student

CONTACT

+4527128044; anne-mette.ragle@regionh.dk

Peter Busch Østergren, MD, PhD

CONTACT

peter.busch.oestergren@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Testers of physical tests (Handgrip strength test and chair-stand-test) and the the statistician will be blinded for allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: RCT

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 14, 2024
• Study Start: February 6, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

DK (1)