NCT04783454

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
31mo left

Started Nov 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Nov 2020Dec 2028

Study Start

First participant enrolled

November 12, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

8.1 years

First QC Date

February 26, 2021

Last Update Submit

November 15, 2023

Conditions

Keywords

desktop workersteleworkremote worksedentary workprimary prevention

Outcome Measures

Primary Outcomes (2)

  • neck pain

    Did you develop neck pain (YES or NO)

    1 year

  • low back pain

    Did you develop low back pain (YES or NO)

    1 year

Secondary Outcomes (8)

  • behavioral change

    1 year

  • physical activity (Baecke Questionnaire)

    1year

  • time to exposure

    1year

  • global perceived effect

    1year

  • use of (pain) medication and/or (para)medical care

    1year

  • +3 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

* single (online) educational video on how the prevention program is designed and general advice on (how to adopt) a healthy lifestyle * 12-week training program: 2 sessions of 60 minutes per week, with the focus of the first session on cardiovascular exercises, and the focus of the second session on mobility and strengthening exercises

Other: Exercise program

control

NO INTERVENTION

no intervention (wait and see approach)

Interventions

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

Intervention

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University

Ghent, East Flanders, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Neck PainLow Back PainBack Pain

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
All investigators and outcome assessors are blind to the subjects' allocation
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2021

First Posted

March 5, 2021

Study Start

November 12, 2020

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations