NCT04204486

Brief Summary

This study aims to assess current health and fitness of law enforcement workers in various roles, and to evaluate the impact of an exercise intervention on markers on physical and mental wellbeing in this population. The intervention will consist of an exercise programme specifically targeted at improving, physical fitness and reducing musculoskeletal pain. Participants will be randomised to three groups: a face to face intervention group, an online intervention group an a control group. Self-reported physical health, musculoskeletal complaints, quality of sleep and occupational stress will be measured via questionnaires. Pre and post measures of fitness will be measured via functional strength testing and a cardiopulmonary exercise test. Pre and post cognitive function will be measured via computer-based cognitive tests and brain functional near-infrared spectroscopy (fNIRS). Systemic inflammation will be measured via hsCRP. Risk of typeII diabetes will be measured via HbA1c. Daily physical activity and quality of sleep will be measured via accelerometry and heart rate telemetry. It is hypothesised that, upon completion of the programme, there will be an improvement in cardiovascular fitness and physical strength, reduced musculoskeletal pain, improved cognitive readiness and improved overall mental health and wellbeing.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jan 2020

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 19, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

January 3, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

5 months

First QC Date

December 3, 2019

Last Update Submit

March 23, 2020

Conditions

Keywords

ExerciseStrengthSource MemoryContext MemoryInhibitionExecutive FunctionSOSIShift workpolicelaw enforcementmilitaryOral healthQuality of SleepCognitionFitness

Outcome Measures

Primary Outcomes (7)

  • Changes in musculoskeletal pain: measured via the Nordic Scale

    Complaints of musculoskeletal pain, collected via a Nordic Scale. The scale runs from 0-10, where 0 is no pain at all and 10 is worst imaginable pain.

    Change from baseline after 8 weeks

  • Change in upper body strength endurance (push)

    Numbers of pushups performed in one minute with good form (eg. not dipping the hips and using full range of motion)

    Change from baseline after 8 weeks

  • Change in upper body strength endurance (pull)

    Numbers of inverted rows performed in one minute with good form (eg. not dipping the hips and using full range of motion)

    Change from baseline after 8 weeks

  • Change in leg strength, measured via the Triple Hop test

    Participants perform three hops on one leg. The total distance (cm) of the three hops is recorded. The test is repeated for both legs.

    Change from baseline after 8 weeks

  • Change in lower limb power

    Participants perform a counter-movement jump on a jump mat (Chronojump). Power (Watts) is recorded.

    Change from baseline after 8 weeks

  • Change in hand grip strength

    Hand grip strength (Newtons) is measured with a hand-held dynamometer.

    Change from baseline after 8 weeks

  • Change in Cardiovascular fitness

    measured via CPET test

    Change from baseline after 8 weeks

Secondary Outcomes (18)

  • Change in simple reaction time after maximal exercise

    Change from baseline after a single bout of maximal exercise (CPET)

  • Change in simple reaction time after an exercise intervention

    Change from baseline after 8 weeks

  • Change in Motor Inhibition after maximal exercise

    Change from baseline after a single bout of maximal exercise (CPET)

  • Change in Motor Inhibition after an exercise intervention

    Change from baseline after 8 weeks

  • Change in source memory after maximal exercise

    Change from baseline after a single bout of maximal exercise (CPET)

  • +13 more secondary outcomes

Study Arms (3)

Face to face exercise intervention

EXPERIMENTAL

Participants will participate in face to face exercise programme delivered by a strength and conditioning coach. Sessions will last 1 hour, 3 times a week, and will be offered at the work place. The coach will register attendance in order to monitor compliance.

Behavioral: Exercise

Online exercise intervention

ACTIVE COMPARATOR

Participants will be given the same training programme as the face to face group, but via an online app. Sessions should last 1 hour and should be completed 3 times a week. Participants will be asked to post a "work-out picture" on the social platform of the app as proof that they completed their session.

Behavioral: Exercise

Control

NO INTERVENTION

This group will undergo all pre and post tests, but will not receive an intervention.

Interventions

ExerciseBEHAVIORAL

Functional strength training, 1 hour, 3 times a week.

Face to face exercise interventionOnline exercise intervention

Eligibility Criteria

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

You may qualify if:

  • Healthy
  • Working in law enforcement

You may not qualify if:

  • Participants with any form of physical injury, neuromuscular, respiratory or cardiovascular condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The ISEH

London, W1T 7HA, United Kingdom

RECRUITING

MeSH Terms

Conditions

Musculoskeletal PainOccupational StressInflammationMotor ActivityInhibition, PsychologicalSleep Initiation and Maintenance Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsOccupational DiseasesStress, PsychologicalBehavioral SymptomsBehaviorPathologic ProcessesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Flaminia Ronca, PI

CONTACT

Paul Burgess, CoPI

CONTACT

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a randomised control trial. Participants will be stratified by shift pattern and by role, and will be randomised to one of three intervention arms using permuted blocks of 3 and 6.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2019

First Posted

December 19, 2019

Study Start

January 3, 2020

Primary Completion

May 30, 2020

Study Completion

June 30, 2023

Last Updated

March 24, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

All data will be anonymised and will be reported as group mean data

Locations