Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001025921
Ethics application status
Approved
Date submitted
23/09/2011
Date registered
27/09/2011
Date last updated
27/09/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Controlled Trial of InteractiVe Exergames in Diabetes
Scientific title
A Phase II, Randomised, Open, Controlled Trial of the Effects of Active Video Games on Physical Activity Levels for Sedentary People with Type 2 Diabetes Mellitus
Secondary ID [1] 263099 0
None
Universal Trial Number (UTN)
Trial acronym
ACTIVE-D
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus Type 2 270853 0
Condition category
Condition code
Metabolic and Endocrine 271029 271029 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A structured programme of Nintendo Wii Sport, specifically, tennis in groups of 4 participants. Supervised by an exercise physiologist. Duration of 30 minutes in week 1 and 2, and increasing to 40 minutes in week 3, twice per week, over a 4 week period.
Intervention code [1] 269446 0
Lifestyle
Comparator / control treatment
Usual physical activity. Namely, the same level of exercise or physical activity the participant would take if they were not in the trial.
Control group
Active

Outcomes
Primary outcome [1] 279688 0
To assess the efficacy of Nintendo Wii Game Technology to increase physical activity levels as measured by the International Physical Activity Questionnaire in participants with Diabetes Mellitus Type 2.
Timepoint [1] 279688 0
Baseline, 4-weeks intervention/control, final assessment at 6-weeks
Secondary outcome [1] 294224 0
a) To assess the efficacy of Nintendo Wii Game Technology to increase health status in participants with Diabetes Mellitus Type 2. Assessment is by the SF-36 Health related-quality of life questionnaire.
Timepoint [1] 294224 0
Baseline, 4-weeks intervention/control, final assessment at 6-weeks
Secondary outcome [2] 294238 0
b) To assess the efficacy of Nintendo Wii Game Technology to increase quality of life in participants with Diabetes Mellitus Type 2. Assessment is by the EuroQoL EQ-5D quality of life questionnnaire.
Timepoint [2] 294238 0
Baseline, 4-weeks intervention/control, final assessment at 6-weeks
Secondary outcome [3] 294239 0
c) To assess the efficacy of Nintendo Wii Game Technology to increase fitness in participants with Diabetes Mellitus Type 2. Assessment is by functional performance measures namely Body Mass index, handgrip strength, timed up and go test, 30 second repeated chair rise test, FICSIT-4 balance test, heart rate.
Timepoint [3] 294239 0
Baseline, 4-weeks intervention/control, final assessment at 6-weeks
Secondary outcome [4] 294240 0
d) To assess the safety of Nintendo Wii Game Technology in participants with Diabetes Mellitus Type 2. Assessment is by the McGill Pain questionnaire short-form, Borgs rating of perceived exertion, adverse event report form.
Timepoint [4] 294240 0
Baseline, 4-weeks intervention/control, final assessment at 6-weeks
Secondary outcome [5] 294241 0
e) To inform the design of a planned randomised controlled trial. This study will also allow testing of recruitment techniques, compliance, testing of questionnaires for burden and ease of use. Assessment is by questionnaires containing open questions on the participants experience of the intervention, time to complete questionnaire will be recorded, a log recording number of particpants approached,screened, eligible will be taken to assess recruitment strategy.
Timepoint [5] 294241 0
Baseline, 4-weeks intervention/control, final assessment at 6-weeks
Secondary outcome [6] 294242 0
f) To evaluate the experience of the participants on the experience of playing active video games via qualitative interview.
Timepoint [6] 294242 0
After each exercise session during 4-weeks intervention

Eligibility
Key inclusion criteria
a) Participant is capable of giving informed consent;
b) Aged >= 18 years and < 75 years;
c) Diagnosed with stable type 2 diabetes mellitus;
d) Are sedentary (sedentary behaviour for this study includes activities that do not involve energy expenditure greater than 1.0-2.9 metabolic equivalent units (METs). Potential participants are eligible if they have NOT participated in any “brisk walking or more energetic activity in the previous month”)
e) Reside in the Ipswich Area;
f) Can attend exercise classes during working hours
g) Has GP advice that they are well enough to participate in moderate-to-vigorous physical activity
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Receiving insulin therapy (due to increased risk of hypoglycaemia);
b) Participating in physical activity > = 2 times per week for at least 20 minutes per session or in a formal physical activity programme;
c) Participating in another study;
d) Has active video games at home;
e) Reports changes in oral hypoglycaemic medications during the previous 2 months;
f) Reports a change of > = 5% of body weight during previous 2 months;
g) Has serum creatinine > = 200 micromol/l;
h) Has proteinuria > 1g/ 24h;
(i) Has blood pressure > 160/95 mmHg;
(j) Has other medical conditions including injuries making participation inadvisable;
(k) Given GP advice not to participate

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will be sourced from GP practices and media coverage in the Ipswich Area. GPs will refer patients to the study who may benefit from a structured moderate-to-vigorous intensity physical activity programme and who meet the eligibility criteria. Allocation will be concealed by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be by Permuted block randomisation with the stratifying factors sex (M,F) and age (<55, 55+). Randomisation will occur after the baseline assessment.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269925 0
University
Name [1] 269925 0
New Staff Research Fund, The University of Queensland
Country [1] 269925 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Research Road
The University of Queensland
St. Lucia, Brisbane, 4072
Country
Australia
Secondary sponsor category [1] 268927 0
None
Name [1] 268927 0
Address [1] 268927 0
Country [1] 268927 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271891 0
Medical Research Ethics Committee
Ethics committee address [1] 271891 0
Ethics committee country [1] 271891 0
Australia
Date submitted for ethics approval [1] 271891 0
15/07/2010
Approval date [1] 271891 0
03/09/2010
Ethics approval number [1] 271891 0
2010001051

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33196 0
Address 33196 0
Country 33196 0
Phone 33196 0
Fax 33196 0
Email 33196 0
Contact person for public queries
Name 16443 0
Hugh Senior
Address 16443 0
School of Medicine
The University of Queensland
11 Salisbury Road
Ipswich 4305
Queensland
Country 16443 0
Australia
Phone 16443 0
+61733811577
Fax 16443 0
Email 16443 0
[email protected]
Contact person for scientific queries
Name 7371 0
Hugh Senior
Address 7371 0
School of Medicine
The University of Queensland
11 Salisbury Road
Ipswich 4305
Queensland
Country 7371 0
Australia
Phone 7371 0
+61733811577
Fax 7371 0
Email 7371 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.