Exercise, Rest Breaks and Ergonomics Modification on Fatigue and MSK Discomfort in Static Workstation

July 19, 2021 updated by: Riphah International University

Effects of Exercise, Rest Breaks and Ergonomics Modification on Fatigue and Musculoskeletal Discomfort in Static Workstation Office Workers

The current study examines the effects of exercise, ergonomic modifications, and rest breaks on fatigue and musculoskeletal discomfort during computer tasks. For the purpose of this project, musculoskeletal discomfort is defined as a constellation of signs and symptoms that include muscle tension, paresthesia, pain, and/or physical strain in soft tissues and bones.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Static workstation workers frequently experience musculoskeletal discomfort which, according to a survey of the literature, may include muscle tension, muscle fatigue, paresthesia, pain, and/or physical strain in soft tissues and bones. The incidence of musculoskeletal discomfort in office workers like computer users is as high as 50%. In various studies on static workstation workers, musculoskeletal discomfort has been reported, either separately or in aggregate, in the neck, shoulders, elbows, wrists, hands, back, legs, buttocks, ankles, feet, and chest.

The current study examines the effects of exercise, ergonomic modifications, and rest breaks on fatigue and musculoskeletal discomfort during computer tasks. For the purpose of this project, musculoskeletal discomfort is defined as a constellation of signs and symptoms that include muscle tension, paresthesia, pain, and/or physical strain in soft tissues and bones.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Islamabad, Punjab, Pakistan
        • Foundation University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Both male and female
  • Age: 25-45 years
  • Those static workstation office workers using a computer for at least 6 hours per day.
  • Static workstation office workers screened by ROSA.

Exclusion Criteria:

  • Discomfort from non-musculoskeletal origin
  • Recent history of trauma and receiving any kind of treatment for the current condition
  • Severe orthopedic disease
  • Any mental and physiological illness that could interfere in the exercise

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Exercise Without Rest Breaks
Other: Exercise Without Rest Break

Participants in the exercise group will receive 'Exercise Breaks', of 10 minutes, twice a day during the work hours, in addition to the two 'Conventional Rest Breaks' of 15 minutes, twice a day during the work hours.

Exercises include shoulder shrugs, neck tilts, wrist and forearm stretch, back and hip stretch, upper body stretch, hamstring stretch, upper back stretch, hand/finger stretch. Side stretch and neck stretch.

Follow up 3 times a week for 5 weeks.
Experimental: Exercise With Rest Break
Other: Exercise With Rest Break

Participants in the exercise with rest break group will receive 'Exercise Breaks', of 10 minutes, twice a day during the work hours, in addition to the two 'Conventional Rest Breaks' of 15 minutes, twice a day during the work hours.

Participants will also receive 'Supplemental Micro Breaks', of 30 seconds after every 15 minutes of working on a static computer workstation Follow up 3 times a week for 5 weeks.
Experimental: Rest Break
Other: Rest Break

Participants in the rest breaks group will receive 'Supplemental Micro Breaks', of 30 seconds after every 15 minutes of working on a static computer workstation in addition to the two 'Conventional Rest Breaks' of 15 minutes twice a day during the work hours.

Follow up 3 times a week for 5 weeks. During the rest breaks, participants will not perform any exercises.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cornell Musculoskeletal Discomfort Questionnaire
Time Frame: 6th week
To assess the severity of musculoskeletal discomfort. minimum as Never = 0, and maximum as Several times every day = 10 The discomfort score is the severity of discomfort categorized as 'mild', 'moderate', and 'severe discomfort'.
6th week
Chalder fatigue scale
Time Frame: 6th week
Each of the 11 items is answered on a 4-point scale ranging from the asymptomatic to maximum symptomology, such as 'Better than usual', 'No worse than usual, 'Worse than usual, and 'Much worse than usual.
6th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 14, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 10, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/00858 Anam Rehman

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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