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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04783454
Other study ID # BC-08635
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 12, 2020
Est. completion date December 31, 2028

Study information

Verified date November 2023
Source University Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the effect of a general training program and educational session to prevent neck and/or low back pain in desktop workers


Description:

After being informed about the study and potential risks, all subjects that met the preset inclusion criteria and gave written informed consent to participate will be randomized into an intervention or control group in a 1:1 ratio. Next, subjects of both groups will undergo baseline testing (online survey). The subjects of the intervention group receive a single educational video (online) and are motivated to follow 2 training sessions of 60 minutes each, during 12 consecutive weeks. Instructions for the specific exercises are provided via an online platform. The subjects of the control group are instructed to maintain their normal working activities and activities of daily life and receive no further intervention. Subjects of both groups are prompted to fill out a weekly online logbook to gather information on their physical activity and neck and/or back complaints. All subjects undergo post-intervention testing at 12 weeks (short term effects), 6 months, and 12 months (long term effects).


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date December 31, 2028
Est. primary completion date November 30, 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 69 Years
Eligibility Inclusion Criteria - age between 18-69 years - perform regular desktop work (at least 20 hours/week) - perform desktop work for at least 1 year (employee or student) Exclusion Criteria: - documented structural neck- and/or back pathology (confirmed by medical imaging) - known shoulder or vestibular pathology - whiplash-associated disorders - history of surgery in the neck, shoulder, hip, and/or back area - (history of) chronic pain condition - serious headache - serious cardiovascular/metabolic/systemic/neurological conditions - chronic fatigue syndrome - fibromyalgia - psychiatric conditions or history of serious depression - serious catastrophizing thoughts - pregnancy or delivery in the past year

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise program
educational video on training program design and healthy lifestyle 24 training sessions (12 on cardiovascular endurance training, 12 on mobility and strength)

Locations

Country Name City State
Belgium Ghent University Ghent East Flanders

Sponsors (1)

Lead Sponsor Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary neck pain Did you develop neck pain (YES or NO) 1 year
Primary low back pain Did you develop low back pain (YES or NO) 1 year
Secondary behavioral change Tendency to remain physically active (PA) during working hours as compared to before your participation in this study (Likert-type scale: not at all PA - slightly less PA - equally PA - slightly more PA - clearly more PA) 1 year
Secondary physical activity (Baecke Questionnaire) physical activity measurement (activities are scored on a scale of 1-5 with the total scored from 3-15. the lower the score, the less physically active) 1year
Secondary time to exposure amount of desktop work (hours/week) 1year
Secondary global perceived effect What is your global perceived effect of the intervention program (NRS - score/100) 1year
Secondary use of (pain) medication and/or (para)medical care use of (pain) medication and/or (para)medical care (name, dosage/frequency, effect, prescribed or direct acces) 1year
Secondary Depression Anxiety Stress Scale-21 (DASS-21 questionnaire) fear, depressive mood, and stress due to COVID-19 crisis and confinement (21 items, Each item is scored from 0 to 3 and is doubled so the global ISI score ranges from 0 to 42) 1year
Secondary 36-Item Short Form Health Survey (SF-36 questionnaire) quality of life during confinement and telework (item scores are summed to scale scores and transformed into a hundred point scale; scores are transformed so that a higher score indicates better health status) 1year
Secondary Insomnia severity index (ISI questionnaire) quality of sleep during confinement and telework (7 items, Each item is scored from 0 to 4 and the global ISI score ranges from 0 to 28) 1year
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