Text Size

Nintendo Wii Fitness Plus Training in Men With Prostate Cancer

This study is not yet open for participant recruitment.
Verified January 2013 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: January 4, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of this study is to investigate the effect of 12 weeks systematically training using the Nintendo Wii system.

Outcome measures are made on physical function, quality of life and fatigue.


Condition Intervention
Metastatic Prostate Cancer
 Behavioral: Training using the Nintendo Wii Fitness Plus 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: Nintendo Wii Training in Men With Metastatic Prostate Cancer Receiving Androgen Deprivation Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospitalsenheden Vest:

Primary Outcome Measures:
  • The effect of 12 weeks systematically training using the Nintendo Wii system measured using the Short Form - 36 (SF-36) subscale related to physical health. [ Time Frame: Change from baseline in outcome measures at 12 weeks training ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The effect of 12 weeks systematically training on quality of life and fatigue using the Nintendo Wii system. [ Time Frame: Change from baseline inoutcome measures at 12 weeks training ] [ Designated as safety issue: No ]

    Methods:

    European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-30).

    Functional assessment of chronic illness therapy - Fatigue/ FACIT - F. 6 minutes walk test. Isokinetic leg press from The University of Nottingham Medical School, Nottingham, United Kingdom.



Estimated Enrollment: 80
Study Start Date: February 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Training using Nintendo Wii System
12 weeks systematically training using the Nintendo Wii Fitness Plus system.
 Behavioral: Training using the Nintendo Wii Fitness Plus system
Training 3 times a week for 12 weeks using the Nintendo Wii Fitness Plus system
No Intervention: Control group
No systematically training

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 stabil cancer prostate disease will receive a letter with information about the study.

A research assistant will be responsible for inclusion. A physiotherapist will be responsible for instruction of the participants to the training and Nintendo Wii system.

A student will be responsible for installation and collection of the Nintendo Wii 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 with bone metastasis verified on bone scan
  • 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 cardio training 2 times or more per week within 3 months 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
  • Television produced before 1995
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01762241

Contacts
Contact: Brigitta R Villumsen, M.S.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, 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: January 4, 2013
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Hospitalsenheden Vest:
Mestastatic prostate cancer
Nintendo Wii training

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

ClinicalTrials.gov processed this record on May 23, 2013