None listed
Conditions
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.
Interventions
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 (
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.
Sponsors
Academic Unit for Psychiatry of Old Age, University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed