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Xbox Kinect Training in Men With Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Home based training using the Xbox Kinect system
Sponsored by
Hospitalsenheden Vest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate cancer, Androgen deprivation therapy, Exercise, Xbox

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Urinvejskirurgisk afdeling, Aarhus Universitetshospital, Skejby
  • Regionshospitalet Holstebro, Urinvejskirurgisk afdeling
  • Urologisk afdeling, Regionshospitalet Viborg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

12 weeks systematically home based training 3 times per week one hour at the time using the Xbox Kinect system.

No systematically training/standard of care

Outcomes

Primary Outcome Measures

The effect of 12 weeks systematically training with the Xbox Kinect system on physical function
6 min walk test

Secondary Outcome Measures

The effect of 12 weeks systematically training with the Xbox Kinect on body composition
Method: BIoelectrical impedance analysis Bioelectrical impedance
The effect of 12 weeks systematically training with the Xbox Kinect system on physical function
Leg extensor power
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
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
The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
Waist circumference (cm)
The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
Blood pressure (mmHg)
The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
Body weight (kg)
The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
Blood glucose (mmol/L)
The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
Plasma triglyceride (mmol/L)
The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
Plasma cholesterol (mmol/L)
The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
Plasma High-density lipoprotein (HDL-cholesterol) (mmol/L)
The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
Plasma Low-density lipoprotein (LDL-cholesterol) (mmol/L)
The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
Leptin (µg/L)
The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
Adiponectin (mg/L)
The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
Leptin:Adiponectin ratio
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
The effect of 12 weeks systematically training with the Xbox Kinect system on insulin
Insulin (pmol/L)
The effect of 12 weeks systematically training with the Xbox Kinect system on insulin resistance
Homeostasis model assessment for insulin resistance (HOMA-IR)
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)
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)

Full Information

First Posted
December 20, 2012
Last Updated
February 27, 2019
Sponsor
Hospitalsenheden Vest
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1. Study Identification

Unique Protocol Identification Number
NCT01762241
Brief Title
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

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospitalsenheden Vest

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate cancer, Androgen deprivation therapy, Exercise, Xbox

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
12 weeks systematically home based training 3 times per week one hour at the time using the Xbox Kinect system.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No systematically training/standard of care
Intervention Type
Behavioral
Intervention Name(s)
Home based training using the Xbox Kinect system
Intervention Description
Home based training 3 times a week for 12 weeks using the Xbox Kinect system
Primary Outcome Measure Information:
Title
The effect of 12 weeks systematically training with the Xbox Kinect system on physical function
Description
6 min walk test
Time Frame
Change from baseline to week 12
Secondary Outcome Measure Information:
Title
The effect of 12 weeks systematically training with the Xbox Kinect on body composition
Description
Method: BIoelectrical impedance analysis Bioelectrical impedance
Time Frame
Change from baseline to week 12
Title
The effect of 12 weeks systematically training with the Xbox Kinect system on physical function
Description
Leg extensor power
Time Frame
Change from baseline to week 12
Title
The effect of 12 weeks systematically training with the Xbox Kinect system on fatigue
Description
Fatigue measured using the Functional Assessment of Canter Therapy-Fatigue questionnaire
Time Frame
Change from baseline to week 12
Title
The effect of 12 weeks systematically training with the Xbox Kinect system on quality of life
Description
Quality of life measured using the Functional Assessment of Canter Therapy-Prostate questionnaire
Time Frame
Change from baseline to week 12
Title
The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
Description
Waist circumference (cm)
Time Frame
Change from baseline to week 12
Title
The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
Description
Blood pressure (mmHg)
Time Frame
Change from baseline to week 12
Title
The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
Description
Body weight (kg)
Time Frame
Change from baseline to week 12
Title
The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
Description
Blood glucose (mmol/L)
Time Frame
Change from baseline to week 12 and week 24
Title
The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
Description
Plasma triglyceride (mmol/L)
Time Frame
Change from baseline to week 12 and week 24
Title
The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
Description
Plasma cholesterol (mmol/L)
Time Frame
Change from baseline to week 12 and week 24
Title
The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
Description
Plasma High-density lipoprotein (HDL-cholesterol) (mmol/L)
Time Frame
Change from baseline to week 12 and week 24
Title
The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
Description
Plasma Low-density lipoprotein (LDL-cholesterol) (mmol/L)
Time Frame
Change from baseline to week 12 and week 24
Title
The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
Description
Leptin (µg/L)
Time Frame
Change from baseline to week 12 and week 24
Title
The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
Description
Adiponectin (mg/L)
Time Frame
Change from baseline to week 12 and week 24
Title
The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
Description
Leptin:Adiponectin ratio
Time Frame
Change from baseline to week 12 and week 24
Title
The effect of 12 weeks systematically training with the Xbox Kinect system on the prevalence of the metabolic syndrome
Description
The five components of the metabolic syndrome: blood glucose, triglyceride, HDL-cholesterol, waist circumference, blood pressure
Time Frame
Change from baseline to week 12
Title
The effect of 12 weeks systematically training with the Xbox Kinect system on insulin
Description
Insulin (pmol/L)
Time Frame
Change from baseline to week 12 and week 24
Title
The effect of 12 weeks systematically training with the Xbox Kinect system on insulin resistance
Description
Homeostasis model assessment for insulin resistance (HOMA-IR)
Time Frame
Change from baseline to week 12 and week 24
Title
The effect of 12 weeks systematically training with the Xbox Kinect system on Insulin Growth Factor-I (IGF-I), bioactive IGF, and IGF-II
Description
IGF-I, bioactive IGF and IGF-II (µg/L)
Time Frame
Change from baseline to week 12 and week 24
Title
The effect of 12 weeks systematically training with the Xbox Kinect system on Insulin Growth Factor Binding Protein 1-3 (IGFBP 1-3)
Description
IGFBP 1-3 (µg/L)
Time Frame
Change from baseline to week 12 and week 24

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brigitta R Villumsen, M.S.N.
Organizational Affiliation
Hospitalsenheden Vest
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urinvejskirurgisk afdeling, Aarhus Universitetshospital, Skejby
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Regionshospitalet Holstebro, Urinvejskirurgisk afdeling
City
Holstebro
ZIP/Postal Code
7500
Country
Denmark
Facility Name
Urologisk afdeling, Regionshospitalet Viborg
City
Viborg
ZIP/Postal Code
8800
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

Xbox Kinect Training in Men With Prostate Cancer

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