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Trial Title:
High Impact Training to Patients With Prostate Cancer and Bone Metastases
NCT ID:
NCT06259279
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Neoplasm Metastasis
Conditions: Keywords:
bone metastases
exercise
bone mineral density
resistance and impact training
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
RCT
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Masking description:
Testers of physical tests (Handgrip strength test and chair-stand-test) and the the
statistician will be blinded for allocation.
Intervention:
Intervention type:
Behavioral
Intervention name:
High intensity high impact exercise intervention
Description:
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.
Arm group label:
Intervention Group
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.
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).
Criteria for eligibility:
Criteria:
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
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Herlev and Gentofte Hospital
Address:
City:
Herlev
Zip:
2730
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Anne-Mette Ragle, PhD student
Phone:
+4527128044
Email:
anne-mette.ragle@regionh.dk
Contact backup:
Last name:
Peter B Østergren, MD PhD
Email:
peter.busch.oestergren@regionh.dk
Start date:
February 6, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Copenhagen University Hospital at Herlev
Agency class:
Other
Source:
Copenhagen University Hospital at Herlev
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06259279
