High Impact Training to Patients With Prostate Cancer and Bone Metastases

Prostate Cancer Clinical Trial

— HIP  

Official title:

High Impact Training to Patients With Prostate Cancer and Bone Metastases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06259279
• Other study ID #: AMRagle
• Status: Recruiting
• Phase: N/A
• Start date: February 6, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: Copenhagen University Hospital at Herlev
• Contact: Anne-Mette Ragle, PhD student
• Phone: +4527128044
• Email: anne-mette.ragle[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Denmark	Herlev and Gentofte Hospital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Copenhagen University Hospital at Herlev

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Fat free mass (kg)	Measured with DXA scans	Change measures baseline, 32 weeks
Secondary	Body fat (% and kg)	Measured with DXA scans	Change measures baseline, 32 weeks
Secondary	Whole Body (BMC, g)	Measured with DXA scans	Change measures baseline, 32 weeks
Secondary	Whole Body (BMD, g/cm2)	Measured with DXA scans	Change measures baseline, 32 weeks
Secondary	Whole body T-score	Measured with DXA scans	Change measures baseline, 32 weeks
Secondary	Lumbar spine (L1-L4 BMD, g/cm2)	Measured with DXA scans	Change measures baseline, 32 weeks
Secondary	Lumbar spine T-score	Measured with DXA scans	Change measures baseline, 32 weeks
Secondary	Total Hip BMD, g/cm2	Measured with DXA scans	Change measures baseline, 32 weeks
Secondary	Total hip T-score Os Calcis BMD, g/cm2 Os calcis T-score	Measured with DXA scans	Change measures baseline, 32 weeks
Secondary	Total hip T-score	Measured with DXA scans	Change measures baseline, 32 weeks
Secondary	Os Calcis BMD, g/cm2	Measured with DXA scans	Change measures baseline, 32 weeks
Secondary	Os calcis T-score	Measured with DXA scans	Change measures baseline, 32 weeks
Secondary	Handgrip strength	Handgrip strength grip test, (measured in Kg, higher score is better outcome)	baseline, 16 weeks, 32 weeks and 44 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Hospitalizations	Registration of hospital admissions in number	Through study completion, an average of 1 year
Secondary	Hospitalizations, causes	Registration of causes for hospital admissions	Through study completion, an average of 1 year
Secondary	Hospitalizations, length of hospitalizations	Registration of hospital admissions in days	Through study completion, an average of 1 year
Secondary	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
Secondary	Feasibility measured by dropout	Feasibility is assessed by dropout in the study	Through study completion, an average of 1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	Qualitative assessment of patients' experiences	Qualitative individual semi-structured interviews with participants from the intervention group	Up to 6 months after study completion