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Xbox Kinect Training in Men With Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01762241
Recruitment Status : Completed
First Posted : January 7, 2013
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Brigitta R. Villumsen, Hospitalsenheden Vest

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Behavioral: Home based training using the Xbox Kinect system Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Xbox Kinect Training in Men With Metastatic Prostate Cancer Receiving Androgen Deprivation Therapy
Actual Study Start Date : February 2015
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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



Primary Outcome Measures :
  1. The effect of 12 weeks systematically training with the Xbox Kinect system on physical function [ Time Frame: Change from baseline to week 12 ]
    6 min walk test


Secondary Outcome Measures :
  1. The effect of 12 weeks systematically training with the Xbox Kinect on body composition [ Time Frame: Change from baseline to week 12 ]
    Method: BIoelectrical impedance analysis Bioelectrical impedance

  2. The effect of 12 weeks systematically training with the Xbox Kinect system on physical function [ Time Frame: Change from baseline to week 12 ]
    Leg extensor power

  3. The effect of 12 weeks systematically training with the Xbox Kinect system on fatigue [ Time Frame: Change from baseline to week 12 ]
    Fatigue measured using the Functional Assessment of Canter Therapy-Fatigue questionnaire

  4. The effect of 12 weeks systematically training with the Xbox Kinect system on quality of life [ Time Frame: Change from baseline to week 12 ]
    Quality of life measured using the Functional Assessment of Canter Therapy-Prostate questionnaire

  5. The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters [ Time Frame: Change from baseline to week 12 ]
    Waist circumference (cm)

  6. The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters [ Time Frame: Change from baseline to week 12 ]
    Blood pressure (mmHg)

  7. The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters [ Time Frame: Change from baseline to week 12 ]
    Body weight (kg)

  8. The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters [ Time Frame: Change from baseline to week 12 and week 24 ]
    Blood glucose (mmol/L)

  9. The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters [ Time Frame: Change from baseline to week 12 and week 24 ]
    Plasma triglyceride (mmol/L)

  10. The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters [ Time Frame: Change from baseline to week 12 and week 24 ]
    Plasma cholesterol (mmol/L)

  11. The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters [ Time Frame: Change from baseline to week 12 and week 24 ]
    Plasma High-density lipoprotein (HDL-cholesterol) (mmol/L)

  12. The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters [ Time Frame: Change from baseline to week 12 and week 24 ]
    Plasma Low-density lipoprotein (LDL-cholesterol) (mmol/L)

  13. The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters [ Time Frame: Change from baseline to week 12 and week 24 ]
    Leptin (µg/L)

  14. The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters [ Time Frame: Change from baseline to week 12 and week 24 ]
    Adiponectin (mg/L)

  15. The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters [ Time Frame: Change from baseline to week 12 and week 24 ]
    Leptin:Adiponectin ratio

  16. The effect of 12 weeks systematically training with the Xbox Kinect system on the prevalence of the metabolic syndrome [ Time Frame: Change from baseline to week 12 ]
    The five components of the metabolic syndrome: blood glucose, triglyceride, HDL-cholesterol, waist circumference, blood pressure

  17. The effect of 12 weeks systematically training with the Xbox Kinect system on insulin [ Time Frame: Change from baseline to week 12 and week 24 ]
    Insulin (pmol/L)

  18. The effect of 12 weeks systematically training with the Xbox Kinect system on insulin resistance [ Time Frame: Change from baseline to week 12 and week 24 ]
    Homeostasis model assessment for insulin resistance (HOMA-IR)

  19. The effect of 12 weeks systematically training with the Xbox Kinect system on Insulin Growth Factor-I (IGF-I), bioactive IGF, and IGF-II [ Time Frame: Change from baseline to week 12 and week 24 ]
    IGF-I, bioactive IGF and IGF-II (µg/L)

  20. The effect of 12 weeks systematically training with the Xbox Kinect system on Insulin Growth Factor Binding Protein 1-3 (IGFBP 1-3) [ Time Frame: Change from baseline to week 12 and week 24 ]
    IGFBP 1-3 (µg/L)



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01762241


Locations
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Denmark
Urinvejskirurgisk afdeling, Aarhus Universitetshospital, Skejby
Aarhus, Denmark, 8000
Regionshospitalet Holstebro, Urinvejskirurgisk afdeling
Holstebro, Denmark, 7500
Urologisk afdeling, Regionshospitalet Viborg
Viborg, Denmark, 8800
Sponsors and Collaborators
Hospitalsenheden Vest
Investigators
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Principal Investigator: Brigitta R Villumsen, M.S.N. Hospitalsenheden Vest

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Responsible Party: Brigitta R. Villumsen, PhD stud., Study Nurse, Master of Science in Nursing, Hospitalsenheden Vest
ClinicalTrials.gov Identifier: NCT01762241    
Other Study ID Numbers: Wii-1-10-72-593-12
1-10-72-593-12 ( Other Identifier: Hospitalsenheden Vest )
First Posted: January 7, 2013    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Keywords provided by Brigitta R. Villumsen, Hospitalsenheden Vest:
Prostate cancer
Androgen deprivation therapy
Exercise
Xbox
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs