Protocol summary

Summary
Objectives: Comparing the effect of different sit-stand schedule on physiological and mental parameters, and productivity in office personnel. Design: Studied population is university office workers that 45 subjects (male and female) from them as sample will be chosen based on simple random method. The blinding will not be done and study will be conducted as a single-center. Setting and conduct: Before intervention, outcomes of the study in the sample will be measured. Samples are divided into 3 groups by block randomization (2 intervention groups and 1 control group) and interventions will last for 2 months. After this period (2 months), outcomes will be measured again. Participants: People who have work experience more than one year, included in the study and people with musculoskeletal, psychological and hormonal disorders symptoms, will be excluded. Intervention: In this study, intervention is height-adjustable desk and schedule time. Schedule time includes 3 groups: time regime 1 (30 minute in sitting and 30 minutes in standing position), time regime 2 (45 minute in sitting and 15 minutes in standing position) and control group (usual sitting position). Main outcome measures: Variables including working energy expenditure, blood parameters (HDL, LDL, glucose, cortisol, insulin, inflammatory factors (TNFα, hs-CRP and IL6) and serotonin), pulse rate, level of depression, prevalence of musculoskeletal disorders symptoms, level of fatigue, level of productivity and level of discomfort before and after intervention will be assessed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016111122071N2
Registration date: 2017-01-05, 1395/10/16
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-01-05, 1395/10/16
Registrant information
Name
Hadi Daneshmandi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3725 1001
Email address
daneshmand@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for Research and Technology Affairs, Shiraz University of Medical Sciences
Expected recruitment start date
2017-01-09, 1395/10/20
Expected recruitment end date
2017-03-10, 1395/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of comparison the effect of different sit-stand schedules on physiological and mental parameters, and productivity in office personnel
Public title
Effect of active ergonomic workstation on official personnel
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: People's willingness to participate in the study; Job experience more than 1 year. Exclusion criteria: Presence of acute musculoskeletal disorders in the spine and lower limbs; Presence of mental and hormonal disorders; People who follow a specific dietary regime; People who follow a specific exercise schedule.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, a block randomization will be done.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice-Chancellor for Research and Technology Affairs, The central building of Shiraz University of Medical Sciences, Zand Blvd, Shiraz, Iran.
City
Shiraz
Postal code
Approval date
2016-08-21, 1395/05/31
Ethics committee reference number
IR.SUMS.REC.1395.99

Health conditions studied

1

Description of health condition studied
Sitting behavior in office workers
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
Fatigue
Timepoint
Before intervention, 2 months after the beginning of the intervention
Method of measurement
Multidimensional Assessment of Fatigue (MAF) scale

2

Description
Productivity
Timepoint
Before intervention, 2 months after the beginning of the intervention
Method of measurement
Health and Work Questionnaire (HWQ)

3

Description
Energy expenditure
Timepoint
Before intervention, 2 months after the beginning of the intervention
Method of measurement
Bodymedia sensewear system

4

Description
High-Density Lipoprotein (HDL)
Timepoint
Before intervention, 2 months after the beginning of the intervention
Method of measurement
Autoanalyzer apparatus

5

Description
Low-Density Lipoprotein (LDL)
Timepoint
Before intervention, 2 months after the beginning of the intervention
Method of measurement
Autoanalyzer apparatus

6

Description
Blood glucose
Timepoint
Before intervention, 2 months after the beginning of the intervention
Method of measurement
Autoanalyzer apparatus

7

Description
Blood cortisol
Timepoint
Before intervention, 2 months after the beginning of the intervention
Method of measurement
Enzyme-Linked Immunosorbent Assay (ELISA) method

8

Description
Blood insulin
Timepoint
Before intervention, 2 months after the beginning of the intervention
Method of measurement
Enzyme-Linked Immunosorbent Assay (ELISA) method

9

Description
Proinflammatory factor of high-sensitivity C-Reactive Protein (hs-CRP)
Timepoint
Before intervention, 2 months after the beginning of the intervention
Method of measurement
Enzyme-Linked Immunosorbent Assay (ELISA) method

10

Description
Interleukin 6 (IL-6)
Timepoint
Before intervention, 2 months after the beginning of the intervention
Method of measurement
Enzyme-Linked Immunosorbent Assay (ELISA) method

11

Description
Tumor Necrosis Factor-α (TNF-α)
Timepoint
Before intervention, 2 months after the beginning of the intervention
Method of measurement
Enzyme-Linked Immunosorbent Assay (ELISA) method

12

Description
Blood serotonin
Timepoint
Before intervention, 2 months after the beginning of the intervention
Method of measurement
Enzyme-Linked Immunosorbent Assay (ELISA) method

13

Description
Pulse rate
Timepoint
Before intervention, 2 months after the beginning of the intervention
Method of measurement
Pulse rate meter

14

Description
Depression
Timepoint
Before intervention, 2 months after the beginning of the intervention
Method of measurement
Beck depression questionnaire

15

Description
Musculoskeletal disorders symptoms
Timepoint
Before intervention, 2 months after the beginning of the intervention
Method of measurement
Nordic Musculoskeletal Questionnaire (NMQ)

16

Description
Discomfort
Timepoint
Before intervention, 2 months after the beginning of the intervention
Method of measurement
Visual Analog Scale (VAS)

Secondary outcomes

1

Description
-
Timepoint
-
Method of measurement
-

Intervention groups

1

Description
Intervention group 2: 15 office personnel will work in accordance with the schedule of 45 minutes in sitting and 15 minutes in standing position for 2 months (working hours of 7 to 8 per day). In this study, the intervention is a height adjustable desk that has been designed and built by the study researchers.
Category
Prevention

2

Description
Intervention group 1: 15 office personnel will work in accordance with the schedule of 30 minutes in sitting and 30 minutes in standing position for 2 months (working hours of 7 to 8 per day). In this study, the intervention is a height adjustable desk that has been designed and built by the study researchers.
Category
Prevention

3

Description
Control group: 15 office personnel will work like before (in sitting position) for 2 months (working hours of 7 to 8 per day).
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Health & School of Nutrition and Food Sciences
Full name of responsible person
Hadi Daneshmandi
Street address
Koye Zahra Blvd
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Masoom Masoompour
Street address
Vice-Chancellor for Research and Technology Affairs, The central building of Shiraz University of Medical Sciences, Zand Blvd, Shiraz, Iran.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hadi Daneshmandi
Position
Ph.D Student of Ergonomics
Other areas of specialty/work
Street address
Research Center for Health Sciences, School of Health, Koye Zahra Blvd, Shiraz, Iran.
City
Shiraz
Postal code
Phone
+98 7137251001296
Fax
Email
daneshmand@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Alireza Choobineh
Position
Ph.D of Occupational Health Engineering
Other areas of specialty/work
Street address
Research Center for Health Sciences, School of Health, Koye Zahra Blvd, Shiraz, Iran.
City
Shiraz
Postal code
Phone
+98 7137251001291
Fax
Email
alrchoobin@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hadi Daneshmandi
Position
Ph.D Student of Ergonomics
Other areas of specialty/work
Street address
Research Center for Health Sciences, School of Health, Koye Zahra Blvd, Shiraz, Iran.
City
Shiraz
Postal code
Phone
+98 7137251001296
Fax
Email
daneshmand@sums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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