NCT03467594

Brief Summary

BE@Work (Brief Exercise at Work) is a pilot controlled before and after trial of a workplace physical activity programme.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 5, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 16, 2018

Completed
24 days until next milestone

Study Start

First participant enrolled

April 9, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
Last Updated

April 10, 2019

Status Verified

April 1, 2019

Enrollment Period

7 months

First QC Date

March 5, 2018

Last Update Submit

April 8, 2019

Conditions

Outcome Measures

Primary Outcomes (12)

  • Aerobic fitness

    Chester step test. This involves stepping onto and off a box at a height relevant to the participants age and usual physical activity level, at a set pace for a maximum of 10 minutes or until the participants heart rate reaches ≥80% of age-predicted maximum, whichever is first. Second-to-second heart rate (HR) will be monitored using a wrist worn heart rate monitor (Polar A360, Polar Electro Oy, Finland).

    8 weeks

  • Alternative measure of aerobic fitness

    If the participant chooses, they can also have their aerobic fitness measured using a ramp test. This will involve attending the Exercise Physiology Laboratory at Teesside University. Peak oxygen uptake will be measured by a ramp test on an electromechanically braked cycle ergometer (Lode Excalibure, Groningen, Netherlands). Participants will perform 5 minutes of submaximal exercise as a standard warm-up. Beginning with no load, power output will increase by 30 Watts (W) per minute until volitional exhaustion or the subject can no longer maintain a pedal cadence of 70-90 revolutions per minute. Expired gas will be collected and analysed throughout (Zan 600 USB CPX, nSpire Health Inc., United Kingdom), with peak oxygen uptake defined as the peak value of a 5-point average data set).

    8 weeks

  • Hand grip strength

    Hand grip strength will be measured using a hand dynamometer. The participant will stand with arms at their side, not touching their body holding the dynamometer in their non-dominant hand. The participant will be asked to squeeze the dynamometer with as much force as possible.

    8 weeks

  • Leg extensor power

    Leg extensor power will be assessed using the Nottingham leg extensor power rig, (Medical Engineering Unit, University of Nottingham, Nottingham, UK). The participant is seated in an adjustable seat and presses a foot pedal until the leg is extended. This petal accelerates a flywheel, and it is this average power in watts that is measured.

    8 weeks

  • Resting blood pressure

    Resting blood pressure will be measured using an electronic blood pressure monitor (Omron, M6 AC ME, Omron Healthcare, Kyoto, Japan).

    8 weeks

  • Blood lipid concentration

    Blood lipids will be assessed from a finger prick blood sample using the Cholestech LDX analyser (Cholestech Corporation, Hayward, CA, USA). The LDX analyser is currently used for the National Health Service Health Checks. Standard aspectic techniques will be used. A small puncture will be made in the middle finger using a one piece single use finger stick. The sample will be drawn into a 35 μL capillary tube and immediately transferred into a cassette sample well. The cassette will then be placed into the device drawer for analysis.

    8 weeks

  • Body Mass Index

    Body mass index will be calculated using the standard formula in units of kg/m2. Measurements of height and body mass will be taken using a standard scale and stadiometer.

    8 weeks

  • Health related quality of life

    Health related quality of life will be measured using a validated self-report paper based questionnaire (SF-36) (RAND, 2016). High scores mean higher quality of life.

    8 weeks

  • Mental wellbeing

    Mental wellbeing will be assessed using a validated self-report paper based questionnaire (Warwick Edinburgh Mental Wellbeing Scale) (Tennant et al., 2007). The total score is obtained by summing the score for each of the 14items. Total scores range from 14-70, higher scales indicate higher mental wellbeing.

    8 weeks

  • Stress

    Stress will be measured using a validated self-report paper based questionnaire (Perceived Stress Scale) (Cohen \& Williamson, 1988). Scores ranging from 0-13, 14-26 and 27-40 would be considered low, medium and high perceived stress, respectively.

    8 weeks

  • Blood glucose concentration

    Fasting blood glucose (mmol/L) will be assessed from a finger prick blood sample using the Cholestech LDX analyser (Cholestech Corporation, Hayward, CA, USA). The LDX analyser is currently used for the National Health Service Health Checks. Standard aspectic techniques will be used. A small puncture will be made in the middle finger using a one piece single use finger stick. The sample will be drawn into a 35 μL capillary tube and immediately transferred into a cassette sample well. The cassette will then be placed into the device drawer for analysis.

    8 weeks

  • Waist circumference

    Waist and hip circumference will be measured using non-elastic Gulick tape measure (G-tape) at the narrowest point of the waist and broadest part of the hip.

    8 weeks

Secondary Outcomes (1)

  • Accelerometer assessed habitual physical activity

    8 weeks

Study Arms (2)

Intervention arm

EXPERIMENTAL

8 week workplace based exercise programme, 3 exercise sessions each week. Exercises will be conducted in an interval training format (60 second exercise bursts, followed by 75 seconds rest). The exercise bursts are designed to elicit ≥85% of participants age predicted maximum heart rate and will be tailored to each individuals fitness level and ability. Exercise sessions will be supervised and conducted in groups, with the option to request individual one-to-one sessions if preferred. Outcome measures assessed at baseline and follow-up (8 weeks)

Behavioral: High-intensity interval training

Control

NO INTERVENTION

Outcome measures only at baseline at follow-up (8 weeks)

Interventions

• Exercises will be conducted in an interval training format (60 second exercise bursts, followed by 75 seconds rest). The exercise bursts are designed to elicit ≥85% of participants age predicted maximum heart rate and will be tailored to each individuals fitness level and ability. Exercise sessions will be conducted 3 times per week for 8 weeks and will last between 15-25 minutes.

Intervention arm

Eligibility Criteria

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

You may qualify if:

  • Participants will be adult (≥18 years) with no health conditions that preclude them from exercise (information obtained via their self-report) and able to understand written and spoken English. Participants will be cleared for exercise participation via the Physical Activity Readiness Questionnaire Plus (PARQ+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Teesside University

Middlesbrough, United Kingdom

Location

MeSH Terms

Interventions

High-Intensity Interval Training

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Researcher

Study Record Dates

First Submitted

March 5, 2018

First Posted

March 16, 2018

Study Start

April 9, 2018

Primary Completion

October 31, 2018

Study Completion

October 31, 2018

Last Updated

April 10, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations