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Xbox Kinect Training in Men With Prostate Cancer

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2014 by Hospitalsenheden Vest
Sponsor:
Information provided by (Responsible Party):
Brigitta R. Villumsen, Hospitalsenheden Vest
ClinicalTrials.gov Identifier:
NCT01762241
First received: December 20, 2012
Last updated: October 13, 2014
Last verified: October 2014
  Purpose

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 Intervention
Prostate Cancer
Behavioral: Home based training using the Xbox Kinect system

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Xbox Kinect Training in Men With Metastatic Prostate Cancer Receiving Androgen Deprivation Therapy

Resource links provided by NLM:


Further study details as provided by Hospitalsenheden Vest:

Primary Outcome Measures:
  • The effect of 12 weeks systematically training with the Xbox Kinect system on physical function [ Time Frame: Change from baseline in outcome measure after 12 weeks training ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The effect of 12 weeks systematically training with the Xbox Kinect on body composition [ Time Frame: Change from baseline in outcome measure after 12 weeks training ] [ Designated as safety issue: No ]

    Method:

    Bioelectrical impedance



Other Outcome Measures:
  • The effect of 12 weeks systematically training with the Xbox Kinect system on fatigue [ Time Frame: Change from baseline in outcome measure after 12 weeks training ] [ Designated as safety issue: No ]
  • The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters [ Time Frame: Change from baseline in outcome measure after 12 weeks training ] [ Designated as safety issue: No ]

Estimated Enrollment: 46
Study Start Date: November 2014
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Training using the Xbox Kinect system
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

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01762241

Contacts
Contact: Brigitta R Villumsen, Ms.N. + 45 78439425 brigvill@rm.dk

Locations
Denmark
Regionshospitalet Holstebro, Urinvejskirurgisk afdeling Not yet recruiting
Holstebro, Denmark, 7500
Contact: Brigitta R Villumsen, M.S.N.    + 45 78439425    brigvill@rm.dk   
Principal Investigator: Brigitta R Villumsen, M.S.N.         
Sponsors and Collaborators
Hospitalsenheden Vest
Investigators
Principal Investigator: Brigitta R Villumsen, M.S.N. Hospitalsenheden Vest
  More Information

No publications provided

Responsible Party: Brigitta R. Villumsen, PhD stud., Study Nurse, Master of Science in Nursing, Hospitalsenheden Vest
ClinicalTrials.gov Identifier: NCT01762241     History of Changes
Other Study ID Numbers: Wii-1-10-72-593-12, 1-10-72-593-12
Study First Received: December 20, 2012
Last Updated: October 13, 2014
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Hospitalsenheden Vest:
Prostate cancer
Androgen deprivation therapy
Exercise
Xbox

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014