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Completed

NCT Number: NCT01762241

Xbox Kinect Training in Men With Prostate Cancer

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.

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Key information

Conditions

Prostate Cancer Behavior Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Motor Activity Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Urinvejskirurgisk afdeling, Aarhus Universitetshospital, Skejby, Aarhus, Denmark

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home based training using the Xbox Kinect system

Behavioral

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Hospitalsenheden Vest

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jan 7, 2013
Registry last updated
Mar 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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