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Trial registered on ANZCTR


Registration number
ACTRN12615000671561
Ethics application status
Approved
Date submitted
1/04/2015
Date registered
29/06/2015
Date last updated
3/12/2018
Date data sharing statement initially provided
3/12/2018
Date results information initially provided
3/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of physical activity and reduced sitting program on cognitive and physical function in middle-aged and older adults with type 2 diabetes
Scientific title
Does the physical activity and sitting time reduction program enhance the cognitive benefits of physical activity in community dwelling middle-aged and older adults with type 2 diabetes: a feasibility pilot study
Secondary ID [1] 285754 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 293641 0
Condition category
Condition code
Metabolic and Endocrine 293936 293936 0 0
Diabetes
Physical Medicine / Rehabilitation 295171 295171 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is study involves two intervention programs, both of which will run for 12 weeks. One group will be asked to complete just the physical activity program, while another group will be asked to complete both programs simultaneously, ie. over the same 12 week period.
Physical activity program:
150 minutes of moderate intensity physical activity per week. The program is progressive in duration and intensity and participants will be asked to complete the program as 3 x 50-minute sessions a week (Option 1) or 5 x 30-minute sessions a week (Option 2). Participants will be asked to gradually increase their individual activity by 150 minutes of moderate physical activity per week then maintain this level for the remainder of the 12 weeks. For Option 1 the physical activity will increase in duration from 3 x 20minutes (and warm up and cool down activities) of low intensity activity in week 1 to 3 x 50 minutes of moderate intensity physical activity in week 5). Option 2 will start from 5 x 15 minutes of low intensity activity and build to 5 x30 minutes of moderate intensity physical activity in week 5.) Intensity will be monitored using the Borg Perceived Rate of Exertion scale with intensity in the range10-12. Participants will receive a manual which will include their individualised walking program and they will attend a baseline 1-hour workshop where the facilitator (a research assistant with qualifications in exercise science and training in behaviour change intervention delivery) will outline the physical activity program, explain the activities, how often they will be done, the intensity and how to record on their standardised physical activity diaries. The participants will complete their physical activity program in a home-based format. The diaries will be used to record adherence to the physical activity program.
This group will be offered a workshop on sitting time reduction at the end of the study period.

Sitting time reduction program:
Participants will be asked to stand up and move about after 30 minutes of uninterrupted sitting. The sitting reduction program uses a whole of day approach so that messages are relevant across all waking hours. The intervention is structured so that participants are encouraged to increase the number of ways they change their sitting over the 12 weeks of the intervention from one sitting reduction activity on three days of the week (3 activities) in week 1 to four sitting reduction activities on every day of the week (28 activities) in week 12. Individual participants will receive a 1 hour face to face workshop delivered by a research assistant with qualifications in exercise science and training in behaviour change intervention delivery. This workshop will be one on one and individual particpants will receive information about the potential benefits of reducing prolonged periods of sitting, a demonstration of how to break up sitting time and a discussion about identifying periods of the day when they sit for long periods; nominating strategies to reduce long bouts of sitting; identifying locations within their homes where they can stand during activities they are normally seated for; and identifying barriers to reducing sitting time and ways to overcome them. During the session participants will develop a behaviourally specific action plan of specific activities to reduce sitting time and increase the number of breaks in prolonged sitting time which will be recorded in a sitting time calendar. Adherence to the program will be measured by the sitting time calendars where participants will record the number and type of strategies they attempt each week.
Intervention code [1] 290716 0
Lifestyle
Intervention code [2] 291739 0
Behaviour
Comparator / control treatment
The control group will be asked to continue with their usual care and physical activity routines throughout the study period. Usual care involves continuing with usual physical activity habits, regular health care appointments and treatments outside of the study. At the completion of their participation in the study, they will be offered the opportunity to attend a 2 hour workshop about physical activity and sitting time reduction.
Control group
Active

Outcomes
Primary outcome [1] 293711 0
Primary outcome 1: Adherence to physical activity program calculated as the number of minutes of moderate activity completed relative to the prescribed 150 minutes/week expressed as a percentage. Number of minutes of physical activity completed will be determined from participant self-report activity calendar.
Timepoint [1] 293711 0
12-week follow up
Primary outcome [2] 293712 0
Primary outcome 2: Adherence to sitting time reduction program calculated as the number of target sitting activities completed from the action plan expressed as a percentage. Number of target activities completed will be determined from participant self-report activity calendar.
Timepoint [2] 293712 0
12-week follow up
Primary outcome [3] 293713 0
Primary outcome 3: Retention rate for both the physical activity and sitting time reduction programs
Timepoint [3] 293713 0
12-week follow up
Secondary outcome [1] 311647 0
Secondary outcome 1: Change on Magnetic Resonance Imaging ASL perfusion as a marker of blood flow
Timepoint [1] 311647 0
12-week follow up
Secondary outcome [2] 311774 0
Secondary outcome 2: Change in level of quality of life as indicated by responses on the Short Form 36 Health Survey (SF-36) questionnaire
Timepoint [2] 311774 0
12-week follow up
Secondary outcome [3] 311775 0
Secondary outcome 3: Change in cognitive functioning as measured by a brief cognitive battery including the Mini- Mental State Examination (MMSE), California Verbal Learning Test- Second Edition (CVLT-II), CogState Brief Battery.
Timepoint [3] 311775 0
12-week follow up
Secondary outcome [4] 311776 0
Secondary outcome 4: Change in objectively measured activity and sitting times using accelerometer and inclinometer
Timepoint [4] 311776 0
12-week follow up
Secondary outcome [5] 311777 0
Secondary outcome 5: Change in physical fitness as measured by cardiovascular and functional fitness assessment including 6 minute walk test, balance step test, timed up & go test, grip strength test, and sit-to-stand test.
Timepoint [5] 311777 0
12-week follow up
Secondary outcome [6] 314374 0
Secondary outcome 6: Change on Magnetic Resonance Imaging resting state as a measure of functional connectivity
Timepoint [6] 314374 0
12 week follow up
Secondary outcome [7] 314375 0
Secondary outcome 7: Change on Magnetic Resonance Imaging FLAIR imaging to assess white matter disease load
Timepoint [7] 314375 0
12 week follow up
Secondary outcome [8] 314376 0
Secondary outcome 8: Change on Magnetic Resonance Imaging volumetric data to assess morphological changes including atrophy
Timepoint [8] 314376 0
12 week follow up
Secondary outcome [9] 315375 0
Secondary outcome 9: Change in mood as indicated by scores on the Hospital Anxiety and Depression Scale and Visual Analogue Mood Scale
Timepoint [9] 315375 0
12 week follow up
Secondary outcome [10] 315376 0
Secondary outcome 10: Change in subjective memory complaint as indicated by the Memory Complaint Questionnaire (MAC-Q)
Timepoint [10] 315376 0
12 week follow up

Eligibility
Key inclusion criteria
1) aged between 50-85 years; 2) community dwelling; 3) no known diagnosis of dementia; 4) “insufficiently active”, defined as doing less than 60 minutes/week of Moderate Vigorous Physical Activity for at least the previous 3 months; 5) self-reported estimated sitting time greater than/equal to 5 hrs 40 mins per day (median cut-point from the AusDiab data set); 6) diagnosed with Type II diabetes.
Minimum age
50 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) presence of medical condition that prohibits standing; 2) unstable or life threatening medical condition; 3) medical condition that contra-indicates moderate physical activity; 4) diabetes treatment with insulin; 5) Body Mass Index (BMI) > 40; 6) severe visual or hearing impairment; 7) history of chronic alcohol abuse within the past 5 years; 8) unable to attend the visits; 9) unable to understand spoken or written English; 10) HbA1c level > 8.5 11) unable to undergo Magnetic Resonance Imaging, 12) Geriatric Depression Scale score greater than 6 indicating the presence of clinically significant depressive symptoms, 13) Mini Mental State Exam score less than 24 indicating clinically significant cognitive impairment.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will first undergo screening to ensure they meet criteria for the study. They will then be invited to attend a baseline assessment session. Following this session they will be allocated to a treatment condition.
A list of random allocations will be produced and sent to the investigator not blinded to the group allocation. The allocated numbers will then be put into the appropriate envelopes and assigned to the participants in order following their baseline assessments. The envelopes will be pulled and opened by a research assistant who administering the intervention. The envelopes will be drawn for one person at a time in strict numerical order.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A list of consecutive Study IDs will be assigned to one of the three groups in 1:1:1 ratio using computerised varying-size blocked random allocation. The sequences will be concealed to the investigators undertaking randomisation. Participants who satisfied the study selection criteria will be assigned the next available ID on this list by an investigator directly involved with administering the intervention.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
45 older adults with T2D will be recruited for the study and will be randomised into one of 3 study arms (2 interventions (ST-PA and PA alone) and 1 control). We estimated conservatively a drop out rate of 25-30% and are confident, based on previous functional MRI studies, that n=10 in each group are sufficient to investigate MRI changes between the three groups between baseline and follow-up at three months.
Changes over time and between group differences for each outcome measure (PA adherence, ST adherence, MRI results, quality of life, cognitive function, activity and sitting time, physical fitness) will be analysed with longitudinal mixed-effects regression models with maximum restricted likelihood estimation. The retention rate between the two groups will also be compared.
Correlations between PA, ST reduction and changes in blood flow, brain metabolism and perfusion will be assessed using Spearman’s correlation for continuous data or either Kruskall-Wallis of Fisher’s exact test as appropriate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3542 0
National Ageing Research Institute
Recruitment postcode(s) [1] 9003 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 290323 0
Other
Name [1] 290323 0
Dementia Collaborative Research Centre
Address [1] 290323 0
Centre for Research on Ageing,
Health and Wellbeing (CRAHW)
Bdg 62A cnr Eggleston/Mills Rd
ANU
Canberra, ACT 0200
AUSTRALIA
Country [1] 290323 0
Australia
Primary sponsor type
University
Name
Academic Unit for Psychiatry of Old Age, University of Melbourne
Address
Academic Unit for Psychiatry of Old Age, University of Melbourne, Royal Melbourne Hospital - Royal Park Campus, 34-54 Poplar Rd, Parkville Victoria 3052
Country
Australia
Secondary sponsor category [1] 289040 0
None
Name [1] 289040 0
Address [1] 289040 0
Country [1] 289040 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292033 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 292033 0
Ms Nitya Jani
Office for Research
Level 6 East, Main Building
300 Grattan Street
The Royal Melbourne Hospital VIC 3050
Ethics committee country [1] 292033 0
Australia
Date submitted for ethics approval [1] 292033 0
Approval date [1] 292033 0
14/03/2014
Ethics approval number [1] 292033 0
2013.316

Summary
Brief summary
Recent studies have shown that physical activity and sitting time reduction may have health and cognitive (memory) benefits for individuals with Type 2 diabetes, however, no such study has looked at the benefits of these two programs in combination.
This study aims to investigate whether a physical activity program and a targeted program to reduce sitting time in middle aged and older adults who are not active and who have Type 2 diabetes would be beneficial for physical and cognitive health.
The study will run for 12 weeks. Participants will undergo an initial screening visit to determine if they meet criteria for the study. If they meet criteria they will then be invited to participate in the study which will involve:
1) An assessment visit (approx. 4 hours) including a brief cognitive assessment, health questionnaires, physical fitness assessments and a blood test for Hba1c level, electrolytes and liver function to ensure participant safety.
2) Wearing an accelerometer and inclinometer for 7 days after the assessment visit. These are two small electronic devices (about the size of a man’s watch) that are used to measure overall daily activity.
3) An MRI brain scan at the Royal Melbourne Hospital
And if they are randomised to either of the treatment groups:
4) A workshop visit to be trained in their intervention program
The assessment and MRI visits, and the wearing of the accelerometer and inclinometer will be repeated after the intervention as a 12 week follow up.
This project is a clinical trial involving three groups which participants will be randomly assigned to. Two of the groups will be given a home based physical activity program. Participants will be asked to gradually increase their individual activity by 150 minutes of moderate physical activity per week and trying to maintain this level for 12 weeks. In addition to the physical activity program, one of these groups will set goals to reduce the amount of time they spend sitting each day over the course of the program. Both of these groups will attend a workshop of 1-2 hours at the start of the 12 weeks to inform them about the study programs. The third group will be asked to continue with their usual routines for the 12 week period. At the end of their participation in the study this group will be invited to a 2 hour workshop which will cover information about physical activity and sitting time reduction.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53134 0
Prof Nicola Lautenschlager
Address 53134 0
Academic Unit for Psychiatry of Old Age, The University of Melbourne, Royal Melbourne Hospital - Royal Park Campus, Building 5, 34-54 Poplar Rd, Parkville, VIC 3052 Australia.
Country 53134 0
Australia
Phone 53134 0
+61 3 8387 2213
Fax 53134 0
Email 53134 0
nicolatl@unimelb.edu.au
Contact person for public queries
Name 53135 0
Miss Stephanie Perin
Address 53135 0
Academic Unit for Psychiatry of Old Age, The University of Melbourne, Royal Melbourne Hospital - Royal Park Campus, Building 5, 34-54 Poplar Rd, Parkville, VIC 3052 Australia.
Country 53135 0
Australia
Phone 53135 0
+61 3 8387 2483
Fax 53135 0
Email 53135 0
stephanie.perin@unimelb.edu.au
Contact person for scientific queries
Name 53136 0
Prof Nicola Lautenschlager
Address 53136 0
Academic Unit for Psychiatry of Old Age, The University of Melbourne, Royal Melbourne Hospital - Royal Park Campus, Building 5, 34-54 Poplar Rd, Parkville, VIC 3052 Australia.
Country 53136 0
Australia
Phone 53136 0
+61 3 8387 2213
Fax 53136 0
Email 53136 0
nicolatl@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary