Trial Review

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
ACTRN12624001311549
Ethics application status
Approved
Date submitted
27/11/2023
Date registered
29/10/2024
Date last updated
29/10/2024
Date data sharing statement initially provided
29/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Shaping well-being & healthy habits through physical activity among employees working remotely.
Scientific title
The utility of a tailored physical activity regimen in muscle stiffness, worker wellbeing and presenteeism amongst female employees working remotely or in a hybrid mode resulting from the 2020 global pandemic organisational changes.
Secondary ID [1] 310896 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sedentary lifestyle 332084 0
Condition category
Condition code
Public Health 328807 328807 0 0
Health promotion/education
Mental Health 328808 328808 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention training (Tailored training - described below) will be conducted under the supervision of a physiotherapist trainer. Groups of 10-15 people, exercises in the gym (at the University of Health and Sport Sciences campus). Exercise intensity: moderate t0 vigorous (5 to 7 in Borg RPE scale). Frequency: 3 times a week, 45 minutes sessions. Total duration of the intervention: 4 weeks. The adherence to the intervention will be monitor using session attendance checklists.

Tailored training:
1. General warm-up program - 10 minutes using a stationary bike, treadmill or cross trainer.
2. Stretching exercises (5 min): 2a. Locate mid-thoracic spinal segments on a foam roller and lie on it with the knees flexed. Fold the hands together behind the neck and slightly lift the buttocks from the floor. Then, slowly roll the foam roller up and down the mid-thoracic spine. 2b. In a kneeling position, place the elbows in front of the body on the bench and sit on the heels while flexing the arms. 2c. One leg kneeling position. Emphasise the stretching feeling at the front of the thigh in the back leg. Then emphasise the stretching feeling at the back of the thigh in the front leg. 2d. Repeat with the opposite leg.
3. Sensorimotor exercise (10 min): 3a. Lying position with a small pillow under the neck. Rotate the head slowly right and left through a full range of motion. 3b. Lying position with a small pillow under the neck. Slide the back of the head on the floor up and down. 3c. Four- point kneeling position. Moving the lumbar spine from the lordotic to the kyphotic position. 3d. Standing position. Knees slightly flexed. Move the lumbar spine from the lordotic to the kyphotic position.
4. Strengthening exercises (15 min). 3-4 sets of exercises, without breaks in between. 4a. Standing position. Knees slightly flexed. Lumbar spine in kyphotic position. Reach with the hands as high as possible for 10 seconds. 4b. Standing position. Extend, slightly abduct and externally rotate the arms with the resistance of a rubber band. 4c. Maintain the ‘plank’ position for 30 seconds. 4d. Lying supine. Lift the head of the floor. Maintain the position for 10 seconds.
5. General cool-down exercise. 5 minutes using a stationary bike, treadmill or cross trainer.

The control training (General training - described below) will be conducted under the supervision of a physiotherapist trainer. Groups of 10-15 people, exercises in the gym (at the University of Health and Sport Sciences campus). Exercise intensity: moderate t0 vigorous (5 to 7 in Borg RPE scale). Frequency: 3 times a week, 45 minutes sessions. Total duration of the intervention: 4 weeks. The adherence to the intervention will be monitor using session attendance checklists.

General training:
1. General warm-up program - 10 minutes using a stationary bike, treadmill or cross trainer.
2. General warm-up exercise for the upper body in a standing position (5 min): 2a. circular movement in the wrist joint with finger movement. Each hand separately and with hands folded together. 2b. Circular movement of hands with flection and extension in the elbow joint. 2c. Circular movement of arms in the shoulder joint. 2d. Circular movement of shoulders. 2e. Circular movement of the head.
3. General warm-up exercise for the lower body in a standing position (5 min): 3a. Circular foot movement with and without contact with the floor. 3b. Knee bending with the knee lift to the chest or with the heel lift to the buttock. 3c. Circular movement of both knees in a horizontal plane in a standing position. 3d. Circular movement in the hip joint with elevated leg bent at the knee joint. 3e. Circular movement of the hips in a horizontal plane in a standing position.
4. Strengthening exercises (10 min). 3-4 sets of exercises, without breaks in between. 4a. Four-point kneeling position. Lift one arm and the opposite leg. 4b. Push-ups. 4c. Side lying with elbow support. Hip lift. 4d. sit-ups.
5. Strengthening exercises (10 min). 3-4 sets of exercises, without breaks in between. 5a. Squats. 5b. Rise on the toes 5c. Lunges. 5d. Supine lying position. Hip lift.
6. General cool-down exercise. 5 minutes using a stationary bike, treadmill or cross trainer.
Intervention code [1] 327424 0
Rehabilitation
Intervention code [2] 327944 0
Lifestyle
Comparator / control treatment
During the 4 -week break between the first and second examination, people from the control group will not participate in any training.
Control group
Active

Outcomes
Primary outcome [1] 336489 0
Changes in Muscle Strain
Timepoint [1] 336489 0
Before the 4-week training cycle, after the 4 weeks training cycle, 3 months after training
Primary outcome [2] 336490 0
Changes in the level of Worker Well-being
Timepoint [2] 336490 0
Before the 4-week training cycle, after the 4 weeks training cycle, 3 months after training
Primary outcome [3] 336491 0
Changes in the level of worker presenteeism
Timepoint [3] 336491 0
Before the 4-week training cycle, after the 4 weeks training cycle, 3 months after training
Secondary outcome [1] 428547 0
Changes in types of musculoskeletal problems
Timepoint [1] 428547 0
Before the 4-week training cycle, after the 4 weeks training cycle, 3 months after training
Secondary outcome [2] 428548 0
Composite secondary outcome:
Changes in behavioral patterns, work habits, and the transfer of knowledge and skills acquired during training at an individual level in both experimental groups
Timepoint [2] 428548 0
3 months after the 4 weeks training cycle
Secondary outcome [3] 431866 0
This is a primary outcome (4):
Changes in Muscle Stiffness
Timepoint [3] 431866 0
Before the 4-week training cycle, after the 4 weeks training cycle, 3 months after training
Secondary outcome [4] 431867 0
The Level of Pain
Timepoint [4] 431867 0
Before the 4-week training cycle, after the 4 weeks training cycle, 3 months after training

Eligibility
Key inclusion criteria
Employees working in remote (or hybrid) mode who spend at least half of their work sitting in front of a computer monitor or with a laptop
Minimum age
25 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Musculoskeletal disorders (above 7 sten on the VAS scale)
Participants who practice physical activity after work for more than 2 hours a day
Participating in more than one physical activity intervention program organised by their employers

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 25948 0
Poland
State/province [1] 25948 0
Wroclaw

Funding & Sponsors
Funding source category [1] 315123 0
Self funded/Unfunded
Name [1] 315123 0
Country [1] 315123 0
Primary sponsor type
University
Name
Wroclaw University of Economics and Business
Address
Ul. Komandorska 118/120, 53-345 Wroclaw
Country
Poland
Secondary sponsor category [1] 317137 0
University
Name [1] 317137 0
Wroclaw University of Health and Sport Sciences
Address [1] 317137 0
al. I. J. Paderewskiego 35, 51-612 Wroclaw
Country [1] 317137 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314059 0
Institutional Review Board: the Rector’s Committee for Research Ethics at the Wroclaw University of Economics and Business in Poland
Ethics committee address [1] 314059 0
Ethics committee country [1] 314059 0
Poland
Date submitted for ethics approval [1] 314059 0
Approval date [1] 314059 0
10/05/2024
Ethics approval number [1] 314059 0
11/2024

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

Contacts
Principal investigator
Name 130266 0
A/Prof Dorota Molek-Winiarska,
Address 130266 0
Wroclaw University of Economics and Business, Komandorska 118/120 53-345 Wroclaw.Komandorska 118/120 53-345 Wroclaw
Country 130266 0
Poland
Phone 130266 0
+48713680668
Fax 130266 0
Email 130266 0
[email protected]
Contact person for public queries
Name 130267 0
Adam Paluszak
Address 130267 0
Wroclaw Univerisity of Health and Sport Sciences, al. I.J. Paderewski 35, 51-612 Wroclaw
Country 130267 0
Poland
Phone 130267 0
+48696026024
Fax 130267 0
Email 130267 0
[email protected]
Contact person for scientific queries
Name 130268 0
Adam Paluszak
Address 130268 0
Wroclaw Univerisity of Health and Sport Sciences, al. I.J. Paderewski 35, 51-612 Wroclaw
Country 130268 0
Poland
Phone 130268 0
+48696026024
Fax 130268 0
Email 130268 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The study is unfunded, but the authors are applying for funding from the National Science Centre. This institution requires protection of individual participant data (data management plan). Only investigators and study staff involved in the collection and analysis of the data will have access to (de-identifiable) participant data. Participant data will not be shared with other research groups.


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.