Effectivness of Active Office Intervention | NCT03649893

Studies
Effectivness of Active Office Intervention

NCT03649893

Sponsor

University of Primorska

Status

Unknown status

Last Update Posted

Oct 2, 2019Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Sedentary Lifestyle

Interventions

Active Office

Countries

Slovenia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 5, 2019Estimated

Primary Completion Date

Feb 1, 2020Estimated

Completion Date

Mar 1, 2020Estimated

First Submitted Date

Aug 24, 2018

First Submission Date that Met QC Criteria

Aug 27, 2018

First Posted Date

Aug 28, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2019

Last Update Posted Date

Oct 2, 2019Actual

Name	Class
Innorenew CoE	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The Active Office study is focusing on interventions with potential to reduce sedentary behavior and increase physical activity in office workers. The participants will be devided in two groups, the experimental and the control group. The participants in the experimental group will use active office (sit-to-stand desk, bike desk, seddle chair and active breaks) for one week, whereas the control group will remain in the conventional sitting-desk office. All the participants will wear ActivePal for 5 consecutive day and complete the measurements (heart rate, blood pressure). The goal of the study is to evaluate the effects of active office on sedentary behavior and physical activity levels in office workers.

Detailed Description

Sedentary behavior is racognised as an independent risk factor for the development of non-communicable diseases. It is estimated that office workers spent up to 80 % of their working time sedentary and do not compensate by sitting less in their leisure time. Therefore, interventions with potential to reduce sedentary behavior and increase phyical activity levels are of increasing interest. The aim of this study is to evaluate the effects of active office, including sit-to-stand desk, bike desk, seddle chair, and active breaks, on sedentary behavior, physical activity levels, and cardio-vascular parameters. The study design will be randomised control trial with one experimental and one control group. The participants in the experimental group will use active office for one week whereas the control group will use the conventional office. All the participants will wear ActivePal for 5 consecutive day and complete the measurements (heart rate, blood pressure). The participants will also complete quastionaires about the sedentary behavior and physical activity levels (Sedentary Behavior Questionnaire, Global Physical Activity Questionnaire). Moreover, at the baseline and on the last day of measurements the investigators will measure the work environment factors (light, noise, air flow, temperature). The goal of the study is to evaluate the effects of active office on sedentary behavior and physical activity levels in office workers.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control Group	No Intervention	The control group will use conventional siiting-desk office.
Active Office Group	Experimental	The experimental group will use active offfice, including sit-to-stand desk, bike desk, seddle chair and active breask.	Device: Active Office

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Active Office	Device	Active Office intervention includes sit-to-stand desk, bike desk, seddle chair, and active breaks.	Active Office Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Weekly physical activity levels	Weekly physical activity levels will be measured with ActivePal sensors.	5 days
Weekly sitting time	Weekly sitting time will be measured with ActivePal sensors.	5 days

Secondary Outcomes

Measure	Description	Time Frame
Heart rate	Heart rate will be measured with Polar Heart Rate Monitor.	5 days
Blood Pressure	Blood pressure will be measured with electronic blood pressure monitor.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

office workers spending at least 70 % of their working time sedentary
aged between 18 and 65

Exclusion Criteria:

body mass index > 30kg/m2
pain presence in any musculokeletal part > 3 on 10-level scale
presence of any non-communicable chronical diseases
pregnancy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nejc Sarabon, Phd	Contact	+386 5 662 64 66	00386	nejc.sarabon@fvz.upr.si

Overall Officials

Name	Affiliation	Role
Nejc Sarabon, Phd	University of Primorska	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
InnoRenew		Izola		6310	Slovenia	Nejc Sarabon, Phd

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D057185	Sedentary Behavior

Ancestor Terms

ID	Term
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided