NCT01762241

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2012

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 7, 2013

Completed
2.1 years until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

March 1, 2019

Status Verified

February 1, 2019

Enrollment Period

3.3 years

First QC Date

December 20, 2012

Last Update Submit

February 27, 2019

Conditions

Prostate Cancer

Keywords

Prostate cancerAndrogen deprivation therapyExerciseXbox

Outcome Measures

Primary Outcomes (1)

  • The effect of 12 weeks systematically training with the Xbox Kinect system on physical function

    6 min walk test

    Change from baseline to week 12

Secondary Outcomes (20)

  • The effect of 12 weeks systematically training with the Xbox Kinect on body composition

    Change from baseline to week 12

  • The effect of 12 weeks systematically training with the Xbox Kinect system on physical function

    Change from baseline to week 12

  • The effect of 12 weeks systematically training with the Xbox Kinect system on fatigue

    Change from baseline to week 12

  • The effect of 12 weeks systematically training with the Xbox Kinect system on quality of life

    Change from baseline to week 12

  • The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters

    Change from baseline to week 12

  • +15 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

No systematically training/standard of care

Interventions

Home based training using the Xbox Kinect systemBEHAVIORAL

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

Intervention group

Eligibility Criteria

Age40 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Prostate cancer requiring androgen deprivation therapy
  • Cognitive well-functioning in order to be able to answer questionnaires and train according to instructions
  • Signed informed consent

You may not qualify if:

  • Prostate cancer with metastasis to other regions than bones
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Urinvejskirurgisk afdeling, Aarhus Universitetshospital, Skejby

Aarhus, 8000, Denmark

Location

Regionshospitalet Holstebro, Urinvejskirurgisk afdeling

Holstebro, 7500, Denmark

Location

Urologisk afdeling, Regionshospitalet Viborg

Viborg, 8800, Denmark

Location

MeSH Terms

Conditions

Prostatic NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesBehavior

Study Officials

  • Brigitta R Villumsen, M.S.N.

    Hospitalsenheden Vest

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD stud., Study Nurse, Master of Science in Nursing

Study Record Dates

First Submitted

December 20, 2012

First Posted

January 7, 2013

Study Start

February 1, 2015

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

March 1, 2019

Record last verified: 2019-02

Locations

DK(3)