Image

High Impact Training to Patients With Prostate Cancer and Bone Metastases

High Impact Training to Patients With Prostate Cancer and Bone Metastases

Recruiting
18 years and older
Male
Phase N/A

Powered by AI

Overview

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.

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).

Eligibility

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

Study details
    Prostate Cancer

NCT06259279

Copenhagen University Hospital at Herlev

21 February 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.