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Trial registered on ANZCTR

Registration number

ACTRN12617001517369

Ethics application status

Approved

Date submitted

20/10/2017

Date registered

31/10/2017

Date last updated

13/06/2019

Date data sharing statement initially provided

13/06/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Breaking Up Sitting Time After Stroke (BUST-BP-Dose)

Scientific title

Breaking Up Sitting Time After Stroke - How much less sitting is needed to improve blood pressure after stroke (BUST-BP-Dose): A pilot study

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

BUST-BP-Dose

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Stroke

Condition category

Condition code

Stroke

Haemorrhagic

Stroke

Ischaemic

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

A laboratory based, dose escalation study design will be used. Community dwelling stroke survivors with a moderate walking disability will be recruited to each cohort (n = 10/cohort).
All participants will complete 2 dose-escalation conditions, involving 10 min increments of light-intensity exercise whilst standing (STAND-EX), following a baseline (control) condition. STAND-EX will be split into 2 x 5 min breaks and consist of calf raises, mini squats and marching on the spot. The maximum dose of standing activities will be reached once the dose-limiting threshold (DLT) has been achieved.

DLT:
Failure to achieve at least 80% of the target time in STAND-EX due to fatigue, pain or effort required. The maximum dose for a cohort will be considered reached if 70% or more (n 'greater than or equal to' 7/10) of the cohort have met the DLT.

Dose escalation:
Cohort A – Prolonged, uninterrupted sitting (8 hours) will be broken up by 10 min STAND-EX, followed by 20 min STAND-EX on a separate occasion.
Cohort B – Dose escalation will commence at 20 min STAND-EX and increase by a further 10 min.
Cohort C – Dose escalation will repeat that of Cohort B.
STAND-EX will be evenly distributed across the testing day (according to dose escalation). The initial dose escalation will involve 2 active standing breaks, each completed after the standardised meals (5 min at 09:00 and 5 min at 13:00). The frequency of breaks will increase until DLT is met. Each testing day will be separated by a minimum 4 day washout period.

A standardised breakfast will be provided at approximately 8.30am and lunch at approximately 12.30pm. Meals will contain approximately one third of the participant's energy requirements and the combined macronutrient profile of testing day meals will be in line with the Acceptable Macronutrient Distribution Ranges as recommended by the Nutrient Reference Values for Australians and New Zealanders.

Experimental conditions:
1. Uninterrupted sitting – 8 hours of prolonged, uninterrupted sitting in a comfortable lounge chair (excluding toilet breaks).
2. Dose escalation 1 – Complete the prescribed dose of STAND-EX
3. Dose escalation 2 – Complete an additional 10 minutes of STAND-EX above Dose escalation 1.

Participants will be provided with an activity monitor and an ambulatory blood pressure monitor.
All testing days will be supervised and take place at the Hunter Medical research Institute (HMRI).

Intervention code [1]

Treatment: Other

Comparator / control treatment

Prolonged bout of uninterrupted sitting (8 hours)

Control group

Active

Outcomes

Primary outcome [1]

Blood pressure.

Blood pressure will be measured by an automated, microprocessor controlled ambulatory blood pressure monitor.

Timepoint [1]

Every 30 min during each 8 hour condition

Primary outcome [2]

Ambulatory blood pressure.

Ambulatory blood pressure will be measured by an automated, microprocessor controlled ambulatory blood pressure monitor.

Timepoint [2]

Every 60 min during the 24 hour post each condition

Secondary outcome [1]

Postprandial glucose. Postprandial glucose will be assessed using the i-STAT handheld blood analyser

Timepoint [1]

Every 30 min for 2 hours after the breakfast meal in each condition

Secondary outcome [2]

Postprandial Insulin concentration.

Postprandial Insulin will be measured using commercially available Human Insulin ELISA kits.

Timepoint [2]

Every 30 min for 2 hours after the breakfast meal in each condition

Secondary outcome [3]

Safety.

Safety will be assessed using the dose-limiting threshold (DLT). DLT if defined as failure to achieve at least 80% of the target time in active standing due to fatigue, pain or effort required.

Timepoint [3]

Safety will be assesed one day and one week after each condition.

Secondary outcome [4]

Feasibility.

Feasibility will be measured through meausres of trial fidelity, adherence to the protocol and number of participants able to complete all 3 conditions. Time on task during each condition will be recorded and any deviation to the protocol will be noted.

Timepoint [4]

Feasibility will be assesed during each condition.

Eligibility

Key inclusion criteria

Stroke survivors who are:
• Between 3 months and 10 years post-stroke with moderate walking disability as defined as,
(1) Score of 'greater than or equal to' 3 on the Functional Ambulation Classification (i.e. can independently ambulate on level surfaces),
(2) Walking speed of 'greater than or equal to' 0.4 metres per second
• Able to toilet independently,
• Able to stand from sitting in a lounge chair independently or with minimal assistance of 'less than or equal to' 1 person,
• Highly sedentary (i.e. sit more than 7 hours during waking hours),
• Aged 'greater than or equal to' 18 years.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

• employment in a non-sedentary occupation (i.e. non-office based occupation),
• self-reported < 7 hours/day sitting,
• regularly engaged in physical activity (i.e. 'greater than or equal to' 150 min/week) as assessed by self-report,
• BMI > 45 kg/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 each experimental condition (i.e. chronic low back pain aggravated by prolonged sitting),
• urinary frequency and or 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

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes

Intervention assignment

Other

Other design features

A dose-escalation design.

The dose-escalation incorporates increasing amounts of standing activities across each cohort (n=10 per cohort), until a dose-limiting threshold (DLT) criteria is reached. The DLT is failure to achieve at least 80% of the target time in active standing due to fatigue, pain or effort required. The maximum dose for a cohort will be considered reached if 70% or more (n > 7/10) of the cohort have met the DLT.

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

We estimated the detectable difference in systolic blood pressure (SBP) between the maximum dose of STAND-EX and baseline condition, with 30 participants expected at the maximum dose achieved. This provides 80% power to detect a within-person, between condition difference of 3.5 mmHg in SBP, assuming a SD of 15 mmHg (based on previous exercise trials in stroke survivors) and a within-person correlation of 0.9 (a = 0.05).
SBP, blood glucose and insulin concentrations will be assessed using generalised linear mixed models with random intercepts to account for repeated measures on participants. On achieving the DLT, mean SBP, blood glucose and insulin will be compared with baseline to identify between condition differences. Safety and feasibility outcomes will be evaluated descriptively, and by comparing odds of adverse events across experimental conditions.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/11/2017

Actual

30/11/2017

Date of last participant enrolment

Anticipated

30/11/2019

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Hunter Medical Research Institute

Address [1]

Kookaburra Crt
New Lambton Heights
NSW 2305

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Heart Foundation Vanguard Grant

Address [2]

Australia

Country [2]

Australia

Primary sponsor type

University

Name

University of Newcastle

Address

University Drive
Callaghan NSW 2308

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Human Research Ethics Committee

Ethics committee address [1]

Locked Bag No 1
New Lambton 
NSW 
2305

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

31/05/2017

Approval date [1]

01/08/2017

Ethics approval number [1]

17/06/21/4.04

Ethics committee name [2]

University of Newcastle Human Research Ethics Committee

Ethics committee address [2]

Research & Innovation Services
Research Integrity Unit
The University of Newcastle
Callaghan NSW 2308

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

16/08/2017

Approval date [2]

06/09/2017

Ethics approval number [2]

H-2017-0296

Summary

Brief summary

Living a sedentary lifestyle significantly increases the risk of developing cardiovascular disease and having a subsequent cardiovascular event, such as a stroke. People who have had a stroke spend 75% of their waking hours at home sitting down, which is much higher than healthy age-matched individuals without stroke. This sedentary behaviour is damaging for stroke survivors already comprised cardiovascular health, and is likely a significant contributing factor to the recurrent stroke which 30% of survivors have after their initial event. 
Stroke survivors are very inactive; with very few able to engage in the level of physical activity recommended to improve their cardiovascular health. In people without stroke, breaking up prolonged sitting using regular activity breaks (walking or simple strengthening exercises) significantly improves cardiovascular disease risk factors such as blood pressure and glucose metabolism. Results from our recently completed pilot study indicates that breaking up prolonged sitting time in stroke survivors achieves similar cardiovascular benefits. Breaking up stroke survivor sitting time with simple resistance activities significantly reduced systolic blood pressure (mean 3.6 mmHg reduction). Lowering of blood pressure reduces the risk of hypertension, the leading modifiable risk factor associated with recurrent stroke, and thus has the potential to reduce the risk of recurrent stroke. Therefore, breaking up sitting time is a promising and innovative physical activity alternative to employ with stroke survivors to improve their cardiovascular health and subsequently, reduce recurrent stroke risk. The next important step is to determine the minimum amount and duration of activity breaks (dose) required to improve these cardiovascular risk factors in this population. 
This study will be the first to determine the optimal dose of simple resistance activities needed to reduce blood pressure and improve glucose metabolism in stroke survivors. Stroke survivors (n = 10 per cohort) living at home who are able to stand and walk will complete a baseline uninterrupted sitting condition followed by 2 dose-escalation conditions. Breaks in sitting will be light-intensity exercise while standing which will increase in 10-min increments each condition. Blood samples will be taken at regular intervals throughout each condition and blood pressure and physical activity will be monitored during and up until 24-hours post-condition. Outcomes of blood pressure (primary), blood glucose, insulin levels (secondary) and safety and feasibility indicators will be collected.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Coralie English

Address

School of Health Sciences, University of Newcastle
University Drive
Callaghan
NSW 2308

Country

Australia

Phone

+61 2 49138102

Fax

coralie.english@newcastle.edu.au

Contact person for public queries

Name

Coralie English

Address

School of Health Sciences, University of Newcastle
University Drive
Callaghan
NSW 2308

Country

Australia

Phone

+61 2 49138102

Fax

coralie.english@newcastle.edu.au

Contact person for scientific queries

Name

Coralie English

Address

School of Health Sciences, University of Newcastle
University Drive
Callaghan
NSW 2308

Country

Australia

Phone

+61 2 49138102

Fax

coralie.english@newcastle.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Only de-identified data will be published, as allowed in the approved ethics documentation for the trial. All participants who participant provide written consent for their de-identified data to be published in article form.

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

Source	Title	Year of Publication	DOI
Embase	Breaking up sitting time after stroke - How much less sitting is needed to improve blood pressure after stroke (BUST-BP-Dose): Protocol for a dose-finding study.	2019	https://dx.doi.org/10.1016/j.conctc.2018.100310
Embase	The Effects of Interrupting Prolonged Sitting With Frequent Bouts of Light-Intensity Standing Exercises on Blood Pressure in Stroke Survivors: A Dose Escalation Trial.	2021	https://dx.doi.org/10.1123/jpah.2020-0763

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added automatically