Clinical trial NCT01762241: Xbox Kinect Training in Men With Prostate Cancer
Official title: Xbox Kinect Training in Men With Metastatic Prostate Cancer Receiving Androgen Deprivation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate cancer
Androgen deprivation therapy
Exercise
Xbox
Lead sponsor: Hospitalsenheden Vest
Sponsor class: OTHER
First posted: 2013-01-07
Enrollment: 46
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The effect of 12 weeks systematically training with the Xbox Kinect system on physical function
timeFrame: Change from baseline to week 12
Secondary outcomes:
measure: The effect of 12 weeks systematically training with the Xbox Kinect on body composition
timeFrame: Change from baseline to week 12
measure: The effect of 12 weeks systematically training with the Xbox Kinect system on physical function
timeFrame: Change from baseline to week 12
measure: The effect of 12 weeks systematically training with the Xbox Kinect system on fatigue
timeFrame: Change from baseline to week 12
measure: The effect of 12 weeks systematically training with the Xbox Kinect system on quality of life
timeFrame: Change from baseline to week 12
measure: The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
timeFrame: Change from baseline to week 12
measure: The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
timeFrame: Change from baseline to week 12
measure: The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
timeFrame: Change from baseline to week 12
measure: The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
timeFrame: Change from baseline to week 12 and week 24
measure: The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
timeFrame: Change from baseline to week 12 and week 24
measure: The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
timeFrame: Change from baseline to week 12 and week 24
measure: The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
timeFrame: Change from baseline to week 12 and week 24
measure: The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
timeFrame: Change from baseline to week 12 and week 24
measure: The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
timeFrame: Change from baseline to week 12 and week 24
measure: The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
timeFrame: Change from baseline to week 12 and week 24
measure: The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
timeFrame: Change from baseline to week 12 and week 24
measure: The effect of 12 weeks systematically training with the Xbox Kinect system on the prevalence of the metabolic syndrome
timeFrame: Change from baseline to week 12
measure: The effect of 12 weeks systematically training with the Xbox Kinect system on insulin
timeFrame: Change from baseline to week 12 and week 24
measure: The effect of 12 weeks systematically training with the Xbox Kinect system on insulin resistance
timeFrame: Change from baseline to week 12 and week 24
measure: The effect of 12 weeks systematically training with the Xbox Kinect system on Insulin Growth Factor-I (IGF-I), bioactive IGF, and IGF-II
timeFrame: Change from baseline to week 12 and week 24
measure: The effect of 12 weeks systematically training with the Xbox Kinect system on Insulin Growth Factor Binding Protein 1-3 (IGFBP 1-3)
timeFrame: Change from baseline to week 12 and week 24
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Urinvejskirurgisk afdeling, Aarhus Universitetshospital, Skejby
city: Holstebro
country: Denmark
facility: Regionshospitalet Holstebro, Urinvejskirurgisk afdeling
city: Viborg
country: Denmark
facility: Urologisk afdeling, Regionshospitalet Viborg
Study officials:
affiliation: Hospitalsenheden Vest
name: Brigitta R Villumsen, M.S.N.
role: PRINCIPAL_INVESTIGATOR
References: