High Impact Training to Patients With Prostate Cancer and Bone Metastases (HIP)

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Behavioral: High intensity high impact exercise intervention

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).

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne-Mette Ragle, PhD student; Phone Number: +4527128044; Email: anne-mette.ragle@regionh.dk
• Study Contact Backup: Name: Peter Busch Østergren, MD, PhD; Email: peter.busch.oestergren@regionh.dk

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Recruiting
    • Herlev and Gentofte Hospital
    • Contact: Anne-Mette Ragle, PhD student; Phone Number: +4527128044; Email: anne-mette.ragle@regionh.dk
    • Contact: Peter B Østergren, MD PhD; Email: peter.busch.oestergren@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 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; 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.
No Intervention: Control Group; standard care. Patients in the control group are referred to the municipal standard rehabilitation programs if the patient so wishes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fat free mass (kg)	Measured with DXA scans	Change measures baseline, 32 weeks
Body fat (% and kg)	Measured with DXA scans	Change measures baseline, 32 weeks
Whole Body (BMC, g)	Measured with DXA scans	Change measures baseline, 32 weeks
Whole Body (BMD, g/cm2)	Measured with DXA scans	Change measures baseline, 32 weeks
Whole body T-score	Measured with DXA scans	Change measures baseline, 32 weeks
Lumbar spine (L1-L4 BMD, g/cm2)	Measured with DXA scans	Change measures baseline, 32 weeks
Lumbar spine T-score	Measured with DXA scans	Change measures baseline, 32 weeks
Total Hip BMD, g/cm2	Measured with DXA scans	Change measures baseline, 32 weeks
Total hip T-score Os Calcis BMD, g/cm2 Os calcis T-score	Measured with DXA scans	Change measures baseline, 32 weeks
Total hip T-score	Measured with DXA scans	Change measures baseline, 32 weeks
Os Calcis BMD, g/cm2	Measured with DXA scans	Change measures baseline, 32 weeks
Os calcis T-score	Measured with DXA scans	Change measures baseline, 32 weeks
Handgrip strength	Handgrip strength grip test, (measured in Kg, higher score is better outcome)	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	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	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.	Through study completion, an average of 1 year
Hospitalizations	Registration of hospital admissions in number	Through study completion, an average of 1 year
Hospitalizations, causes	Registration of causes for hospital admissions	Through study completion, an average of 1 year
Hospitalizations, length of hospitalizations	Registration of hospital admissions in days	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.	Through study completion, an average of 1 year
Feasibility measured by dropout	Feasibility is assessed by dropout in the study	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	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.	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	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	Up to 6 months after study completion

Collaborators and Investigators

• Sponsor: Copenhagen University Hospital at Herlev
• Investigators: Principal Investigator: Anne-Mette Ragle, PhD student, Copenhagen University Hospital at Herlev; Study Director: Peter B Østergren, Peter Østergren

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 29, 2024
• First Submitted That Met QC Criteria: February 6, 2024
• First Posted (Actual): February 14, 2024

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: exercise; bone metastases; bone mineral density; resistance and impact training
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Neoplastic Processes; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Neoplasm Metastasis
• Other Study ID Numbers: AMRagle

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No