Xbox Kinect Training in Men With Metastatic Prostate Cancer Receiving Androgen Deprivation Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 46
- Locations
- 6
- Primary Endpoint
- The effect of 12 weeks systematically training with the Xbox Kinect system on physical function
Study Overview
Brief Summary
The purpose of this study is to investigate the effect of 12 weeks systematically training using the Xbox Kinect system.
Outcome measures are made on physical function, quality of life, fatigue and metabolic parameters.
Detailed Description
Patients will be recruited from the outpatient clinic at the urological department, Regionshospitalet Holstebro.
Patients who have been discharged from the outpatient clinic due to biochemical stabile cancer prostate disease will receive a letter with information about the study.
A research assistant will be responsible for randomization and test procedures. A physiotherapist will be responsible for instruction of the participants to the training and the Xbox system.
A student will be responsible for installation and collection of the Xbox system in the participants home.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Prostate cancer requiring androgen deprivation therapy
- •Androgen deprivation therapy for at least 3 month prior to inclusion
- •Cognitive well-functioning in order to be able to answer questionnaires and train according to instructions
- •Signed informed consent
Exclusion Criteria
- •Prostate cancer with metastasis to other regions than bones
- •Strength- or cardiovascular training 2 times or more per week prior to inclusion
- •Haemoglobin percentage less than 6,1 mmol/l
- •Any mental or physical condition that makes the patient unfit for participation
- •Men in risk of getting an osteoporotic fracture due to long-term treatment with steroids or earlier fractures due to minimal trauma
- •Participation in other studies
Arms & Interventions
Intervention group
12 weeks systematically home based training 3 times per week one hour at the time using the Xbox Kinect system.
Intervention: Home based training using the Xbox Kinect system (Behavioral)
Control group
No systematically training/standard of care
Outcomes
Primary Outcomes
The effect of 12 weeks systematically training with the Xbox Kinect system on physical function
Time Frame: Change from baseline to week 12
6 min walk test
Secondary Outcomes
- The effect of 12 weeks systematically training with the Xbox Kinect on body composition(Change from baseline to week 12)
- The effect of 12 weeks systematically training with the Xbox Kinect system on quality of life(Change from baseline to week 12)
- The effect of 12 weeks systematically training with the Xbox Kinect system on the prevalence of the metabolic syndrome(Change from baseline to week 12)
- The effect of 12 weeks systematically training with the Xbox Kinect system on insulin(Change from baseline to week 12 and week 24)
- The effect of 12 weeks systematically training with the Xbox Kinect system on insulin resistance(Change from baseline to week 12 and week 24)
- The effect of 12 weeks systematically training with the Xbox Kinect system on Insulin Growth Factor Binding Protein 1-3 (IGFBP 1-3)(Change from baseline to week 12 and week 24)
- The effect of 12 weeks systematically training with the Xbox Kinect system on physical function(Change from baseline to week 12)
- The effect of 12 weeks systematically training with the Xbox Kinect system on fatigue(Change from baseline to week 12)
- The effect of 12 weeks systematically training with the Xbox Kinect system on Insulin Growth Factor-I (IGF-I), bioactive IGF, and IGF-II(Change from baseline to week 12 and week 24)
- The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters(Change from baseline to week 12 and week 24)
Investigators
Brigitta R. Villumsen
PhD stud., Study Nurse, Master of Science in Nursing
Hospitalsenheden Vest