Xbox Kinect Training in Men With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01762241
• Other study ID #: Wii-1-10-72-593-12
• Secondary ID: 1-10-72-593-12
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: June 2018

Study information

• Verified date: February 2019
• Source: Hospitalsenheden Vest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Home based training using the Xbox Kinect system
Home based training 3 times a week for 12 weeks using the Xbox Kinect system

Locations

Country	Name	City	State
Denmark	Urinvejskirurgisk afdeling, Aarhus Universitetshospital, Skejby	Aarhus
Denmark	Regionshospitalet Holstebro, Urinvejskirurgisk afdeling	Holstebro
Denmark	Urologisk afdeling, Regionshospitalet Viborg	Viborg

Sponsors (1)

Lead Sponsor	Collaborator
Hospitalsenheden Vest

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	The effect of 12 weeks systematically training with the Xbox Kinect system on physical function	Leg extensor power	Change from baseline to week 12
Secondary	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
Secondary	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
Secondary	The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters	Waist circumference (cm)	Change from baseline to week 12
Secondary	The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters	Blood pressure (mmHg)	Change from baseline to week 12
Secondary	The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters	Body weight (kg)	Change from baseline to week 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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