Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000513415
Ethics application status
Approved
Date submitted
18/04/2016
Date registered
21/04/2016
Date last updated
21/04/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Understanding the negative effects of prolonged sitting: investigating the impact on musculoskeletal discomfort and cardiovascular parameters
Scientific title
Understanding the negative effects of prolonged sitting: investigating the impact on musculoskeletal discomfort and cardiovascular parameters
Secondary ID [1] 289032 0
Nil
Universal Trial Number (UTN)
Trial acronym
Sit Pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 298448 0
Condition category
Condition code
Diet and Nutrition 298548 298548 0 0
Obesity
Metabolic and Endocrine 298549 298549 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participation will involve 2 visits over 1-2 weeks.
1) Consent and screening: including full disclosure of the project aims and requirements; collecting information on medical history; measurements of height, weight, hip and waist, and blood pressure.
2) Experimental Procedure: To minimise potential variability, participants will be asked to refrain from alcohol, caffeine and moderate-to-vigorous activity in the 48 hours prior to the experimental day. They will also be provided with a pre-dinner meal to be consumed between 7-9pm the night before, after which they will be instructed to fast until the beginning of the trial the next morning. Adherence to these requests will be determined via food and activity diaries. On the morning of the trial, following equipment set-up, the participant will be instructed to sit quietly for an initial 1 hour "steady state" period, during which time measurements will be recorded. The participant will then be provided with a breakfast meal, commencing the experimental condition thereafter. The breakfast meal will consist of 55% carbohydrate, 30% fat and 15% protein, and will provide 33% of daily energy needs, based on the Schofield equation. Participants will be asked to sit quietly in a comfortable chair for five hours. They can watch television, DVD’s or read whilst seated. They will be able to have a toilet break whenever they need, but will otherwise be asked to sit as still as possible to avoid interfering with measurement outcomes.
Continuous measures of blood pressure and heart rate (ECG) will be taken. EMG and posture will be recorded every 3 minutes; and discomfort scores every 10 minutes throughout the sitting period. Microneurography of the peroneal nerve will be measured from baseline to 2 hours post meal.
Intervention code [1] 294514 0
Lifestyle
Comparator / control treatment
No control group - comparators involve comparing a time-course of events over the day to baseline measures.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298033 0
Musculoskeletal discomfort (assessed by visual analogue scale)
Timepoint [1] 298033 0
Every 10 minutes whilst participant is seated. Normally completed within 1 minute.
Primary outcome [2] 298059 0
Muscle activity measured using surface electromyography from muscles involving sitting (upper trapezius, lumbar erector spinae, quadriceps, hamstrings)
Timepoint [2] 298059 0
Every 3 minutes for a period of 15 seconds whilst the participant is seated
Primary outcome [3] 298060 0
Spinal posture measured via electromagnetic motion tracking
Timepoint [3] 298060 0
Recorded every 3 minutes for a period of 15 seconds whilst the participant is seated
Secondary outcome [1] 322975 0
postprandial glucose response, continuous assessment measured with a Continuous Glucose Monitor Sensor (CGMS)
Timepoint [1] 322975 0
Measured for 5 hours starting 10 minutes prior to breakfast meal consumption
Secondary outcome [2] 322976 0
Spontaneous Baroreflex (with ECG and continuous BP finapress)
Timepoint [2] 322976 0
Assessed at 30 minute intervals whilst seated for a period of 10 minutes
Secondary outcome [3] 322977 0
Muscle sympathetic nervous activity (MSNA) using microneurography. One microelectrode is inserted under the skin near the head of the fibula, and the other on top of the peroneal nerve.
Timepoint [3] 322977 0
From baseline to 2-hours post-meal

Eligibility
Key inclusion criteria
Participants will be overweight/obese, based on having a BMI between 25 kg/m2 and 40 kg/m2, previous diagnosis of type 2 diabetes greater than 3 months, and be english speaking.
Minimum age
55 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Conditions for exclusion are: diagnosis of type 2 diabetes for less than 3 months; unable to sit for prolonged periods due to musculoskeletal pain; pregnancy; employment in a non-sedentary occupation; currently watching less than 3 hours of television per day; regularly engaged in moderate-intensity exercise for greater than or equal to 150 min/week for greater than 3 months; use of glucose/lipid lowering/antidepressant medications; pre-menopausal or menopausal women; and major illness/physical problems.
These exclusion criteria are necessary to ensure our participants fall within the demographic in which the risk of cardiovascular and diabetic complications due to sedentary behaviour are elevated. This is the target group for future interventions in whom breaks from daily prolonged sitting are likely to be of most benefit.

Study design
Purpose of the study
Prevention
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
12/08/2015
Date of last participant enrolment
Anticipated
Actual
10/09/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
5
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 293394 0
Government body
Name [1] 293394 0
National Health and Medical Research Council (NHMRC)
Country [1] 293394 0
Australia
Primary sponsor type
Individual
Name
Professor David Dunstan
Address
Physical Activity Laboratory
Baker IDI Heart and Diabetes Institute
Level 4, Alfred Centre
99 Commercial Road
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 292225 0
None
Name [1] 292225 0
Address [1] 292225 0
Country [1] 292225 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294851 0
Alfred Health Human Ethics Committee
Ethics committee address [1] 294851 0
Ethics committee country [1] 294851 0
Australia
Date submitted for ethics approval [1] 294851 0
27/05/2015
Approval date [1] 294851 0
29/06/2015
Ethics approval number [1] 294851 0
271/15

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

Contacts
Principal investigator
Name 61806 0
Prof David Dunstan
Address 61806 0
Physical Activity Laboratory
Baker IDI Heart and Diabetes Institute
Level 4, Alfred Centre
99 Commercial Road
Melbourne VIC 3004
Country 61806 0
Australia
Phone 61806 0
+61 3 8532 1873
Fax 61806 0
+61 3 8532 1150
Email 61806 0
[email protected]
Contact person for public queries
Name 61807 0
Megan Grace
Address 61807 0
Physical Activity Laboratory
Baker IDI Heart and Diabetes Institute
Level 4, Alfred Centre
99 Commercial Road
Melbourne VIC 3004
Country 61807 0
Australia
Phone 61807 0
+61 3 8532 1855
Fax 61807 0
+61 3 8532 1150
Email 61807 0
[email protected]
Contact person for scientific queries
Name 61808 0
Megan Grace
Address 61808 0
Physical Activity Laboratory
Baker IDI Heart and Diabetes Institute
Level 4, Alfred Centre
99 Commercial Road
Melbourne VIC 3004
Country 61808 0
Australia
Phone 61808 0
+61385321855
Fax 61808 0
+61 3 8532 1150
Email 61808 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.