Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000023752
Ethics application status
Approved
Date submitted
24/10/2021
Date registered
13/01/2022
Date last updated
25/07/2022
Date data sharing statement initially provided
13/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Acute effects of short-term upper extremity exercises in office workers
Scientific title
Acute effects of short-term upper extremity exercises on pain in office workers
Secondary ID [1] 305642 0
Nil known
Universal Trial Number (UTN)
U1111-1270-8266
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 324074 0
Musculoskeletal Disorders 324075 0
Physical inactivity 324076 0
Lower step count 324077 0
Depression 324078 0
Anxiety 324079 0
Stress 324080 0
Poorer quality of life 324081 0
Condition category
Condition code
Physical Medicine / Rehabilitation 321580 321580 0 0
Physiotherapy
Musculoskeletal 322157 322157 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All individuals in the control and training groups will be advised to do physical activity (at least 7,500 steps per day or 8-10 tours of at least 10 minutes per day) for at least 4-5 days in a week.
In addition to the physical activity recommendation, light upper extremity exercises will be applied to the individuals in the training group. During these sessions, participants are not asked to target a predetermined level of intensity. Upper extremity exercises:
*The light exercise program will consist of exercises including warm-up (stepping and normal range of motions for upper extremity) (3-5 minutes), stretching (upper trapezius muscle, levator scapula muscle, anterior-lateral muscles of the neck, anterior arm muscles, pectoralis major muscle), posture (Raising the shoulders towards the ears, rolling back after raising shoulders to ears), resistance exercises with light-medium free weights (shoulder flexion, shoulder external rotation, medium trapezius, elbow flexion and extension), and cool-down (stepping and normal range of motions for upper extremity) (3-5 minutes).
*These exercises consist of totally 5 sessions due to the nature of this study which will be applied during one session per a day, 5-7 days for only 1 week (if possible within working hours (lunch break)), in the form of an average of 20-30 minutes of sessions under the supervision of a physiotherapist, through audio/video phone calls and/or online video-conferences with Microsoft Teams, one-to-one or in groups, depending on the availability of individuals. Session attendance checklists will be kept in exercise diary for every participant.
Intervention code [1] 322036 0
Treatment: Other
Comparator / control treatment
Adult office workers will be randomly divided into either training group or control group. All individuals in the control group will be advised to do physical activity (at least 7,500 steps per day or 8-10 tours of at least 10 minutes per day) for at least 4-5 days in a week. The individuals in the control group who want to do upper extremity exercises will also be given the same training given to the training group at the end of the 1-week follow-up.
Control group
Active

Outcomes
Primary outcome [1] 329350 0
Change in the score of pain perception which will be evaluated using Numeraical Rating Scale
Timepoint [1] 329350 0
Baseline and at one week after baseline evaluation
Secondary outcome [1] 402253 0
Change in the score of musculoskeletal disorder which will be evaluated using Cornell Musculoskeletal Disorders Questionnaire
Timepoint [1] 402253 0
Baseline and at one week after baseline evaluation
Secondary outcome [2] 402254 0
Change in the score of physical activity which will be evaluated using International Physical Activity Questionnaire Short Form
Timepoint [2] 402254 0
Baseline and at one week after baseline evaluation
Secondary outcome [3] 402255 0
Change in the daily step counts which will be evaluated using pedometer app on mobile phone
Timepoint [3] 402255 0
Baseline and at one week after baseline evaluation
Secondary outcome [4] 402256 0
Change in the score of depression, anxiety and stress levels which will be evaluated using Depression Anxiety Stress-21 Scale
Timepoint [4] 402256 0
Baseline and at one week after baseline evaluation
Secondary outcome [5] 402257 0
Change in the score of quality of life which will be evaluated using SF-36
Timepoint [5] 402257 0
Baseline and at one week after baseline evaluation

Eligibility
Key inclusion criteria
Inclusion criteria for the individuals were:
*adult individuals aged 18 and over
*volunteering to participate in the study,
*Having a smart phone on which the pedometer application can be installed
• Working actively at a desk for at least three years and at least 4 hours a day
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for the individuals were:
*Having an acute or chronic infection, musculoskeletal disease, serious cardiac, orthopedic or neurological disease that may prevent exercise
*Having a serious psychiatric illness and therefore not being able to adapt to exercise sessions
*Being an active employee who does sports regularly
*Being in a situation such as quarantine for any reason
*Being pregnant

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All eligible official workers were blinded and randomly grouped as either training group or control group using a central randomisation computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size required for the study was calculated using the GPower (G*Power 3.0.10 system) program. It was determined that at least 15 individuals should be included in both groups in order for this study to reach an a value of 0.05, an effect size of 0.78, and a power of 80%, in order to determine the mean difference in pain scores (-1.41) between the two groups after the application.
At the end of the study, statistical analyzes will be made using the SPSS 15.0 program. By using visual (histogram and probability graphs) and analytical methods (Kolmogorov-Smirnov/Shapiro-Wilk tests), the conformity of all variables to normal distribution will be investigated. Descriptive analyzes will be given using frequencies and percentage (%) for categorical variables, median, minimum, maximum and interquartile range (IQR) for non-normally distributed variables, mean and standard deviation (x±ss) for normally distributed variables. When comparing the values of the groups before the exercise applications, the Independent Sample t test (Student t test) will be used to compare the variables that fit the normal distribution, the Mann-Whitney U test will be used to compare the data that do not fit, and the Chi-square test will be used to compare the uncountable data. The differences between groups of normally distributed data were x±sd, the difference between means (Mean. difference) and 95% confidence interval (95%CI), the intergroup differences of data indicated by counting with n and %, the differences between groups of data not normally distributed as median, min. It will be given with max and U value. Two-way ANCOVA test will be applied to investigate the effectiveness of remote online exercise training on the mentioned parameters. For post-hoc comparisons, syntax will be written and Bonferroni test will be used. Post-hoc power analysis will be calculated using the results of the evaluated parameters. The probability of error in statistical analysis will be determined as p<0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/03/2022
Actual
14/02/2022
Date of last participant enrolment
Anticipated
Actual
27/05/2022
Date of last data collection
Anticipated
Actual
27/05/2022
Sample size
Target
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 24248 0
Turkey
State/province [1] 24248 0
Izmir

Funding & Sponsors
Funding source category [1] 310000 0
Self funded/Unfunded
Name [1] 310000 0
None
Country [1] 310000 0
Primary sponsor type
Individual
Name
GÜLSAH BARGI
Address
Izmir Democracy University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Mehmet Ali Akman Quarter, 13th street, No. 2, 35140 Güzelyali, Konak, Izmir
Country
Turkey
Secondary sponsor category [1] 311050 0
Individual
Name [1] 311050 0
SINEM SUNER KEKLIK
Address [1] 311050 0
Sivas Cumhuriyet University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, Yenisehir District, Kayseri Street, postcode:58140, Campus-Yenice/ Sivas
Country [1] 311050 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309710 0
Izmir Democracy University Non-Interventional Clinical Research of the Ethics Committee
Ethics committee address [1] 309710 0
Ethics committee country [1] 309710 0
Turkey
Date submitted for ethics approval [1] 309710 0
19/10/2021
Approval date [1] 309710 0
24/11/2021
Ethics approval number [1] 309710 0
2021/15-01

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

Contacts
Principal investigator
Name 115122 0
Dr GÜLSAH BARGI
Address 115122 0
Izmir Democracy University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Mehmet Ali Akman Quarter, 13th street, No. 2, 35140 Güzelyali, Konak, Izmir
Country 115122 0
Turkey
Phone 115122 0
+90 5317938766
Fax 115122 0
+90 232 260 1004
Email 115122 0
[email protected]
Contact person for public queries
Name 115123 0
GÜLSAH BARGI
Address 115123 0
Izmir Democracy University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Mehmet Ali Akman Quarter, 13th street, No. 2, 35140 Güzelyali, Konak, Izmir
Country 115123 0
Turkey
Phone 115123 0
+90 232 260 1001
Fax 115123 0
+90 232 260 1004
Email 115123 0
[email protected]
Contact person for scientific queries
Name 115124 0
GÜLSAH BARGI
Address 115124 0
Izmir Democracy University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Mehmet Ali Akman Quarter, 13th street, No. 2, 35140 Güzelyali, Konak, Izmir
Country 115124 0
Turkey
Phone 115124 0
+90 232 260 1001
Fax 115124 0
+90 232 260 1004
Email 115124 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant anonymized data collected during the trial
When will data be available (start and end dates)?
Immediately following publication, ending 2 years following main results publication.
Available to whom?
case-by-case basis at the discretion of Primary Sponsor and only interested parties or official institutions/organizations who want to access this, provide a sound methodologically justification.
Available for what types of analyses?
any purpose, only to achieve the aims in the approved proposal, for IPD meta-analyses, etc.
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


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.