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Trial registered on ANZCTR


Registration number
ACTRN12615001189516
Ethics application status
Approved
Date submitted
11/10/2015
Date registered
4/11/2015
Date last updated
26/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Breaking Up Sitting Time after Stroke (BUST-Stroke)
Scientific title
Breaking up Sitting Time after Stroke (BUST-Stroke): A randomised within-participant cross-over study to determine the metabolic effects of breaking up uninterrupted sitting time in stroke survivors.
Secondary ID [1] 287618 0
Nil
Universal Trial Number (UTN)
Trial acronym
BUST Stroke
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 296424 0
Condition category
Condition code
Stroke 296688 296688 0 0
Ischaemic
Stroke 296689 296689 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two different experimental conditions:
1. Prolonged sitting (8 hours) during which every 30mins participants will perform exercises in standing for 3 minutes (ie. calf raises, knee lifts semi-squats).
2. Prolonged sitting (8 hours) during which every 30mins participants will walk for 3 minutes.
Activities, time on task during the activity bouts, toilet breaks and any deviations from protocol for each condition will be recorded in the participant's Case Report Form by the research assistant.

There will be a 6 day wash out period between each conditions.

Breakfast will be provided for each participant at approx 8.30am and lunch approx 4 hours later. Each meal provided will contain approximately one third of the participant’s energy requirements and the full day’s meals combined will have a macronutrient profile in line with the Acceptable Macronutrient Distribution Ranges as recommended by the Nutrient Reference Values for Australians and New Zealanders. Carbohydrate contribution will constitute approximately 55% of energy in order to elicit an adequate glucose and insulin response.
Intervention code [1] 293014 0
Treatment: Other
Comparator / control treatment
Prolonged sitting (8 hours) without interruption
Control group
Active

Outcomes
Primary outcome [1] 296293 0
Within-participant, between condition differences in post-prandial glucose (incremental area under the curve) by blood sample.
Timepoint [1] 296293 0
Every hour during each 8 hour condition.
Primary outcome [2] 296392 0
Insulin control by blood sample.
Timepoint [2] 296392 0
Every hour during each 8 hour condition.
Secondary outcome [1] 318093 0
Within-participant, between condition differences in systolic and diastolic blood pressure as measured using a sphygmomanometer.
Timepoint [1] 318093 0
Every half hour during each 8 hour condition.
Secondary outcome [2] 318094 0
Plasma fibrinogen assessed by blood sample
Timepoint [2] 318094 0
Begin and end of each 8 hour condition.
Secondary outcome [3] 318116 0
Feasibility (adherence to protocol) by 1. number of participants completing each condition with few deviations from protocol within each condition and throughout the duration of the study and 2. low scores on the Degree of Difficulty Scale completed by each participant after each testing day.
Timepoint [3] 318116 0
Continuous monitoring of adherence throughout each testing day and the overall duration of the study.

Eligibility
Key inclusion criteria
Stroke survivors who are:
*Greater than or equal to 6 months post-stroke with moderate walking disability as defined as
*score of =2 on the Functional Ambulation Classification (ie. require the assistance of less than or equal to 1 person to safely walk) AND
*walking speed between 0.4 to 0.8m/s
*able to toilet independently and
*able to stand from sitting from a lounge chair independently or with minimal assistance of less than or equal to 1 person
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*employment in a non-sedentary occupation (ie. non-office based occupation),
*self-reported < 4 hours/day sitting
*regularly engaged in physical activity (ie. greater than or equal to 150min/week) as assessed by self-report
*BMI > 45kg/m2
*current smoker
*pregnant
*clinically diagnosed with acute/chronic illness or other condition which has known physical activity contraindications or limits their ability to complete the each experimental condition (ie. chronic low back pain aggravated by prolonged sitting)
*urinary frequency and or urinary urgency or requiring assistance with toileting (other than to mobilise to the toilet) and
*insulin dependent diabetes or who are taking diabetes medication other than metformin.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Yes, via sequentially numbered sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The order of the experimental conditions will be randomised for each participant. Permuted block randomisation will be used. A person independent to the trial will prepare a set of sequentially numbered, sealed, numbered opaque envelopes which contain the experimental condition sequence. At the end of each participation’s familiarisation visit the research assistant will open the next envelope in the sequence to reveal the randomisation schedule.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Note: blinding will only be possible for the analyses of blood samples. This will occur by creating codes for the conditions which will be unknown to the person conducting the assays.
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
The study is powered to detect clinically meaningful differences in post-prandial glucose and insulin incremental area under the curve. Based on previous mean changes (10% for glucose and 60% for insulin, Dunstan 2012b), estimates of population variability (SD 1% glucose and 30% insulin) and assuming a correlation coefficient of 0.5 between repeated measures, 19 paired observations (ie participants) will achieve a power of 0.9 to detect smallest worthwhile effect (two tailed testing, a=0.05).
Differential effects of the experimental conditions on cardio-metabolic biomarkers will be assessed using generalised linear mixed models with random intercepts (recommended best practice for cross-over trials). Safety and feasibility outcomes will be analysed descriptively, and by comparing odds of adverse events across experimental conditions.

Recruitment
Recruitment status
Not yet recruiting
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)
NSW
Recruitment postcode(s) [1] 10642 0
2305 - New Lambton
Recruitment postcode(s) [2] 10643 0
2300 - Newcastle
Recruitment postcode(s) [3] 10644 0
2327 - Kurri Kurri
Recruitment postcode(s) [4] 10645 0
2283 - Toronto

Funding & Sponsors
Funding source category [1] 292182 0
Charities/Societies/Foundations
Name [1] 292182 0
National Stroke Foundation
Address [1] 292182 0
LEVEL 7 461 BOURKE STREET, Melbourne Victoria 3000
Country [1] 292182 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 290857 0
Charities/Societies/Foundations
Name [1] 290857 0
National Stroke Foundation
Address [1] 290857 0
LEVEL 7 461 BOURKE STREET, Melbourne Victoria 3000
Country [1] 290857 0
Australia
Other collaborator category [1] 278649 0
Other
Name [1] 278649 0
Hunter Medical Research Institute
Address [1] 278649 0
Kookaburra Crt
New Lambton Heights
NSW 2305
Country [1] 278649 0
Australia
Other collaborator category [2] 278650 0
Other
Name [2] 278650 0
Baker Institute of Diabetes International
Address [2] 278650 0
Level 4, 99 Commercial Rd, Melbourne, VIC, 3004 Australia
Country [2] 278650 0
Australia
Other collaborator category [3] 278651 0
Other
Name [3] 278651 0
Florey Neuroscience Institutes
Address [3] 278651 0
Level 1, Melbourne Brain Centre, Austin Hospital, 245 Burgundy St, Heidelberg VIC 3084 Australia.
Country [3] 278651 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293655 0
Hunter New England Health Human Research Ethics Committee
Ethics committee address [1] 293655 0
District Headquarters, Administration Building
Lookout Road,
New Lambton NSW 2305
Ethics committee country [1] 293655 0
Australia
Date submitted for ethics approval [1] 293655 0
29/09/2015
Approval date [1] 293655 0
13/11/2015
Ethics approval number [1] 293655 0
15/10/21/4.05

Summary
Brief summary
People who have had a stroke and are living at home spend 75% of their waking hours sitting down, which is much higher than people of a similar age without stroke. Spending long periods of time sitting down each day increases the risk of cardiovascular disease, including stroke, putting this population at particularly high risk. About a third of people who have had one stroke will have a second or third stroke, so it is important that we look for ways to reduce this risk. In studies of people without stroke, breaking up prolonged sitting time with regular activity breaks (walking or simple strengthening exercises) leads to significant reductions in cardiovascular disease risk factors such as glucose metabolism and blood pressure. The effects of breaking up sitting time in people with stroke, and the optimal type of activity break for this group is not known. Not getting enough physical activity is the second highest risk factor for stroke, but achieving the recommended amount of daily physical activity, particularly for those people who find it difficult to walk, is near impossible for many stroke survivors. Therefore, reducing sitting time is a promising, innovative, low cost intervention to reduce the risk of having another stroke. We will conduct a study that will help us to understand the impact of prolonged sitting time on stroke risk factors, and will assess the effectiveness of two ways of regularly breaking up sitting time in people with stroke. We will recruit 19 stroke survivors who have difficulty walking. Each survivor will complete all 3 experimental conditions in a random order, under the direct supervision of research staff at HMRI. The 3 conditions will be (1) prolonged sitting without breaks (control), (2) breaking up sitting time by walking at a comfortable speed overground (ie not on a treadmill) for 3 minutes every 30 minutes, and (3) breaking up sitting time with 3 minutes of simple exercises in standing every 30 minutes. Participating stroke survivors will have blood samples taken at regular intervals throughout the duration of the study, and will have their blood pressure continually monitored. Our study outcome measures will include glucose and insulin measures (primary), blood pressure, plasma fibrinogen (secondary) as well as safety and feasibility indicators.
This study will be first to assess the effects of breaking up prolonged sitting time in people with stroke. We aim to build on this work in the future by testing different types of activity breaks (eg standing only, seated exercises) at varying frequencies and durations in different sub-groups of stroke survivors (eg people who walk well, and those that cannot walk at all). BUST-Stroke will also inform future research to assess the effect of reducing daily sitting time in people both early (in hospital) and later after stroke.
Trial website
N/A
Trial related presentations / publications
None
Public notes
None

Contacts
Principal investigator
Name 60838 0
A/Prof Coralie English
Address 60838 0
Hunter Medical Research Institute, Stroke Research Team Level 3 East, Lot 1, Kookaburra Circuit, New Lambton Heights, NSW, 2305 Australia
Country 60838 0
Australia
Phone 60838 0
+61 2 4913 8102
Fax 60838 0
Email 60838 0
coralie.english@newcastle.edu.au
Contact person for public queries
Name 60839 0
A/Prof Coralie English
Address 60839 0
Hunter Medical Research Institute, Stroke Research Team Level 3 East, Lot 1, Kookaburra Circuit, New Lambton Heights, NSW, 2305 Australia
Country 60839 0
Australia
Phone 60839 0
+61 2 4913 8102
Fax 60839 0
Email 60839 0
Coralie.English@newcastle.edu.au
Contact person for scientific queries
Name 60840 0
A/Prof Coralie English
Address 60840 0
Hunter Medical Research Institute, Stroke Research Team Level 3 East, Lot 1, Kookaburra Circuit, New Lambton Heights, NSW, 2305 Australia
Country 60840 0
Australia
Phone 60840 0
+61 2 4913 8102
Fax 60840 0
Email 60840 0
Coralie.English@newcastle.edu.au

No information has been provided regarding IPD availability
Summary results
No Results