Prostate CancerNCT01762241
Xbox Kinect Training in Men With Prostate Cancer
A study testing Home based training using the Xbox Kinect system in people with Prostate Cancer, run by Hospitalsenheden Vest at 3 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Home based training using the Xbox Kinect system
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 3 sitesDenmark
- Study dates
- Feb 2015to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Urinvejskirurgisk afdeling, Aarhus Universitetshospital, Skejby
Aarhus, 8000
Regionshospitalet Holstebro, Urinvejskirurgisk afdeling
Holstebro, 7500
Urologisk afdeling, Regionshospitalet Viborg
Viborg, 8800
About this study
Official title: Xbox Kinect Training in Men With Metastatic Prostate Cancer Receiving Androgen Deprivation Therapy
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Home based training using the Xbox Kinect system
- Keywords
- Prostate cancer, Androgen deprivation therapy, Exercise, Xbox
- Medical subject headings
- Prostatic Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home based training using the Xbox Kinect systemBehavioural
Home based training 3 times a week for 12 weeks using the Xbox Kinect system
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 12 weeks systematically home based training 3 times per week one hour at the time using the Xbox Kinect system. Receives: Behavioral: Home based training using the Xbox Kinect system |
| Control group | No intervention | No systematically training/standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of 12 weeks systematically training with the Xbox Kinect system on physical function
6 min walk test
Measured: Change from baseline to week 12
Secondary outcomes (20)
The effect of 12 weeks systematically training with the Xbox Kinect on body composition
Method: BIoelectrical impedance analysis Bioelectrical impedance
Measured: Change from baseline to week 12
The effect of 12 weeks systematically training with the Xbox Kinect system on physical function
Leg extensor power
Measured: Change from baseline to week 12
The effect of 12 weeks systematically training with the Xbox Kinect system on fatigue
Fatigue measured using the Functional Assessment of Canter Therapy-Fatigue questionnaire
Measured: Change from baseline to week 12
The effect of 12 weeks systematically training with the Xbox Kinect system on quality of life
Quality of life measured using the Functional Assessment of Canter Therapy-Prostate questionnaire
Measured: Change from baseline to week 12
The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
Waist circumference (cm)
Measured: Change from baseline to week 12
The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
Blood pressure (mmHg)
Measured: Change from baseline to week 12
The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
Body weight (kg)
Measured: Change from baseline to week 12
The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
Blood glucose (mmol/L)
Measured: Change from baseline to week 12 and week 24
The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
Plasma triglyceride (mmol/L)
Measured: Change from baseline to week 12 and week 24
The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
Plasma cholesterol (mmol/L)
Measured: Change from baseline to week 12 and week 24
The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
Plasma High-density lipoprotein (HDL-cholesterol) (mmol/L)
Measured: Change from baseline to week 12 and week 24
The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
Plasma Low-density lipoprotein (LDL-cholesterol) (mmol/L)
Measured: Change from baseline to week 12 and week 24
The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
Leptin (µg/L)
Measured: Change from baseline to week 12 and week 24
The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
Adiponectin (mg/L)
Measured: Change from baseline to week 12 and week 24
The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
Leptin:Adiponectin ratio
Measured: Change from baseline to week 12 and week 24
The effect of 12 weeks systematically training with the Xbox Kinect system on the prevalence of the metabolic syndrome
The five components of the metabolic syndrome: blood glucose, triglyceride, HDL-cholesterol, waist circumference, blood pressure
Measured: Change from baseline to week 12
The effect of 12 weeks systematically training with the Xbox Kinect system on insulin
Insulin (pmol/L)
Measured: Change from baseline to week 12 and week 24
The effect of 12 weeks systematically training with the Xbox Kinect system on insulin resistance
Homeostasis model assessment for insulin resistance (HOMA-IR)
Measured: Change from baseline to week 12 and week 24
The effect of 12 weeks systematically training with the Xbox Kinect system on Insulin Growth Factor-I (IGF-I), bioactive IGF, and IGF-II
IGF-I, bioactive IGF and IGF-II (µg/L)
Measured: Change from baseline to week 12 and week 24
The effect of 12 weeks systematically training with the Xbox Kinect system on Insulin Growth Factor Binding Protein 1-3 (IGFBP 1-3)
IGFBP 1-3 (µg/L)
Measured: Change from baseline to week 12 and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2013 (estimated)
- Study startFeb 2015
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospitalsenheden Vest
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brigitta R. Villumsen, Hospitalsenheden Vest
- Investigators
- Brigitta R Villumsen, M.S.N., Principal investigator, Hospitalsenheden Vest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01762241
- Sponsor's protocol ID
- Wii-1-10-72-593-12
- Other IDs
- 1-10-72-593-12
- Status last verified
- Feb 2019
- First submitted
- 20 Dec 2012
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xbox Kinect Training in Men With Metastatic Prostate Cancer Receiving Androgen Deprivation Therapy
- ClinicalTrials.gov ID
- NCT01762241
- Acronym / sponsor ID
- Wii-1-10-72-593-12
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Androgen deprivation therapy, Exercise, Xbox
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Hospitalsenheden VestUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 7 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Home based training using the Xbox Kinect system12 weeks systematically home based training 3 times per week one hour at the time using the Xbox Kinect system. |
| Control group | No intervention | –No systematically training/standard of care |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home based training using the Xbox Kinect systemHome based training 3 times a week for 12 weeks using the Xbox Kinect system | Behavioural | Intervention group |
Primary outcome
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
20 secondary outcomes
The effect of 12 weeks systematically training with the Xbox Kinect on body composition
Time frame: Change from baseline to week 12
The effect of 12 weeks systematically training with the Xbox Kinect system on physical function
Time frame: Change from baseline to week 12
The effect of 12 weeks systematically training with the Xbox Kinect system on fatigue
Time frame: Change from baseline to week 12
The effect of 12 weeks systematically training with the Xbox Kinect system on quality of life
Time frame: Change from baseline to week 12
The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
Time frame: Change from baseline to week 12
The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
Time frame: Change from baseline to week 12
The effect of 12 weeks systematically training with the Xbox Kinect system on metabolic parameters
Time frame: Change from baseline to week 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
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
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
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
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
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
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
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
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 effect of 12 weeks systematically training with the Xbox Kinect system on insulin
Time frame: Change from baseline to week 12 and week 24
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
Related trials for Prostate Cancer
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Not yet recruitingPhase 3
A Study of JNJ-101556143 With Best Supportive Care in Participants With Metastatic Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
Metastatic Prostate Cancer
RecruitingPhase 2
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
Prostate Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brigitta R Villumsen, M.S.N. principal investigator
Hospitalsenheden Vest
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home based training using the Xbox Kinect system in people with Prostate Cancer, run by Hospitalsenheden Vest at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of 12 weeks systematically training with the Xbox Kinect system on physical function (time frame: Change from baseline to week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2019.