ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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

Condition category

Condition code

Diet and Nutrition

Obesity

Metabolic and Endocrine

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]

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]

Musculoskeletal discomfort (assessed by visual analogue scale)

Timepoint [1]

Every 10 minutes whilst participant is seated. Normally completed within 1 minute.

Primary outcome [2]

Muscle activity measured using surface electromyography from muscles involving sitting (upper trapezius, lumbar erector spinae, quadriceps, hamstrings)

Timepoint [2]

Every 3 minutes for a period of 15 seconds whilst the participant is seated

Primary outcome [3]

Spinal posture measured via electromagnetic motion tracking

Timepoint [3]

Recorded every 3 minutes for a period of 15 seconds whilst the participant is seated

Secondary outcome [1]

postprandial glucose response, continuous assessment measured with a Continuous Glucose Monitor Sensor (CGMS)

Timepoint [1]

Measured for 5 hours starting 10 minutes prior to breakfast meal consumption

Secondary outcome [2]

Spontaneous Baroreflex (with ECG and continuous BP finapress)

Timepoint [2]

Assessed at 30 minute intervals whilst seated for a period of 10 minutes

Secondary outcome [3]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (NHMRC)

Address [1]

Level 1
16 Marcus Clarke Street
Canberra ACT 2601

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Health Human Ethics Committee

Ethics committee address [1]

Office of Ethics & Research Governance
Alfred Health
55 Commercial Road
Melbourne VIC 3004
PO Box 315 Prahran
VIC 3181 Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/05/2015

Approval date [1]

29/06/2015

Ethics approval number [1]

271/15

Summary

Brief summary

Advances in technology, while providing a wide and varied range of benefits, have had the effect of engineering an environment where humans are continually encouraged to sit. This shift toward a more sedentary lifestyle has been linked to a myriad of poor health outcomes, including increased risk of cardiovascular disease, diabetes, and all-cause mortality. Compelling evidence indicates that the global burden of chronic disease and premature deaths attributable to physical inactivity is comparable to smoking. Over the past decade, our lab has revealed that sedentary behaviour (sitting) is associated with elevated markers of cardio-metabolic risk, and premature all-cause and cardiovascular disease mortality. Expanding on the evidence provided from observational studies, we have shown a beneficial effect of breaking up prolonged sitting time with light intensity physical activity on postprandial glucose and insulin metabolism, blood pressure and fibrinogen; and that some of these effects are being mediated by changes at the gene and protein expression level. Despite the progress that has been made, there still remains the question “how much sitting is too much”? This is likely to involve a complicated interplay between several different metabolic processes, and requires the ability to use continuous measures to determine the point at which negative effects occur. Teasing out the mechanisms and time-course of the negative impact of prolonged uninterrupted sitting is a vital next step which could help to inform future intervention strategies and activity guidelines.

In this pilot trial, we aim to assess the impact of 5 hours of prolonged, uninterrupted sitting on various physiological and metabolic parameters in overweight adults with type 2 diabetes (n=5). These parameters include:
(i) muscle activity and posture, leading to musculoskeletal discomfort
(ii) the baroreflex and orthostatic intolerance
(iii) sympathetic nervous system activity via microneurography
One of the main aims of this pilot trial is to test the feasibility of measuring all of these parameters at once, using our standard sitting intervention and musculoskeletal protocols. In particular, we aim to establish whether we can get useful EMG and posture measures with the other equipment and furniture being used; and also determine if we can get clear and meaningful microneurography measurements in the sitting position.
We hypothesise that reduced variation in muscle activity resulting from prolonged sitting and poor posture will lead to musculoskeletal discomfort. Moreover, prolonged sitting will lead to baroreflex dysfunction and orthostatic intolerance. Sympathetic nervous system activity will be tested only for feasibility in this pilot study.

Trial website

Trial related presentations / publications

None

Public notes

Contacts

Principal investigator

Name

Prof David Dunstan

Address

Physical Activity Laboratory
Baker IDI Heart and Diabetes Institute
Level 4, Alfred Centre
99 Commercial Road
Melbourne VIC 3004

Country

Australia

Phone

+61 3 8532 1873

Fax

+61 3 8532 1150

David.Dunstan@bakeridi.edu.au

Contact person for public queries

Name

Megan Grace

Address

Physical Activity Laboratory
Baker IDI Heart and Diabetes Institute
Level 4, Alfred Centre
99 Commercial Road
Melbourne VIC 3004

Country

Australia

Phone

+61 3 8532 1855

Fax

+61 3 8532 1150

megan.grace@bakeridi.edu.au

Contact person for scientific queries

Name

Megan Grace

Address

Physical Activity Laboratory
Baker IDI Heart and Diabetes Institute
Level 4, Alfred Centre
99 Commercial Road
Melbourne VIC 3004

Country

Australia

Phone

+61385321855

Fax

+61 3 8532 1150

megan.grace@bakeridi.edu.au

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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically