Xbox Kinect Training in Men With Prostate Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Xbox Kinect Training in Men With Metastatic Prostate Cancer Receiving Androgen Deprivation Therapy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: Home based training using the Xbox Kinect system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>12 weeks systematically home based training 3 times per week one hour at the time using the Xbox Kinect system. | Behavioral: Home based training using the Xbox Kinect system<br>* Home based training 3 times a week for 12 weeks using the Xbox Kinect system<br>|
| No Intervention: Control group<br>No systematically training/standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of 12 weeks systematically training with the Xbox Kinect system on physical function | 6 min walk test | Change from baseline to week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of 12 weeks systematically training with the Xbox Kinect on body composition | Method: BIoelectrical impedance analysis Bioelectrical impedance | Change from baseline to week 12 | 
| The effect of 12 weeks systematically training with the Xbox Kinect system on physical function | Leg extensor power | Change from baseline to week 12 | 
| The effect of 12 weeks systematically training with the Xbox Kinect system on fatigue | Fatigue measured using the Functional Assessment of Canter Therapy-Fatigue questionnaire | Change from baseline to week 12 | 
| The effect of 12 weeks systematically training with the Xbox Kinect system on quality of life | Quality of life measured using the Functional Assessment of Canter Therapy-Prostate questionnaire | Change from baseline to week 12 | 
| The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters | Waist circumference (cm) | Change from baseline to week 12 | 
| The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters | Blood pressure (mmHg) | Change from baseline to week 12 | 
| The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters | Body weight (kg) | Change from baseline to week 12 | 
| The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters | Blood glucose (mmol/L) | Change from baseline to week 12 and week 24 | 
| The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters | Plasma triglyceride (mmol/L) | Change from baseline to week 12 and week 24 | 
| The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters | Plasma cholesterol (mmol/L) | Change from baseline to week 12 and week 24 | 
| The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters | Plasma High-density lipoprotein (HDL-cholesterol) (mmol/L) | Change from baseline to week 12 and week 24 | 
| The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters | Plasma Low-density lipoprotein (LDL-cholesterol) (mmol/L) | Change from baseline to week 12 and week 24 | 
| The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters | Leptin (µg/L) | Change from baseline to week 12 and week 24 | 
| The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters | Adiponectin (mg/L) | Change from baseline to week 12 and week 24 | 
| The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters | Leptin:Adiponectin ratio | Change from baseline to week 12 and week 24 | 
| The effect of 12 weeks systematically training with the Xbox Kinect system on the prevalence of the metabolic syndrome | The five components of the metabolic syndrome: blood glucose, triglyceride, HDL-cholesterol, waist circumference, blood pressure | Change from baseline to week 12 | 
| The effect of 12 weeks systematically training with the Xbox Kinect system on insulin | Insulin (pmol/L) | Change from baseline to week 12 and week 24 | 
| The effect of 12 weeks systematically training with the Xbox Kinect system on insulin resistance | Homeostasis model assessment for insulin resistance (HOMA-IR) | 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-I (IGF-I), bioactive IGF, and IGF-II | IGF-I, bioactive IGF and IGF-II (µg/L) | 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) | IGFBP 1-3 (µg/L) | Change from baseline to week 12 and week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, Androgen deprivation therapy, Exercise, Xbox