Xbox Kinect Training in Men With Prostate Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Behavioral: Home based training using the Xbox Kinect system

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 Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Urinvejskirurgisk afdeling, Aarhus Universitetshospital, Skejby
  • Holstebro, Denmark, 7500
    • Regionshospitalet Holstebro, Urinvejskirurgisk afdeling
  • Viborg, Denmark, 8800
    • Urologisk afdeling, Regionshospitalet Viborg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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; Home based training 3 times a week for 12 weeks using the Xbox Kinect system
No Intervention: Control group; No systematically training/standard of care

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospitalsenheden Vest
• Investigators: Principal Investigator: Brigitta R Villumsen, M.S.N., Hospitalsenheden Vest

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: December 20, 2012
• First Submitted That Met QC Criteria: January 4, 2013
• First Posted (Estimate): January 7, 2013

Study Record Updates

• Last Update Posted (Actual): March 1, 2019
• Last Update Submitted That Met QC Criteria: February 27, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Exercise; Prostate cancer; Androgen deprivation therapy; Xbox
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: Wii-1-10-72-593-12; 1-10-72-593-12 (Other Identifier: Hospitalsenheden Vest)