High-intensity Interval TrainingNCT03467594
BE@Work: Brief Exercise at Work
A study testing High-intensity interval training in people with High-intensity Interval Training, run by Teesside University at 1 site in United Kingdom.
Trial summary
BE@Work (Brief Exercise at Work) is a pilot controlled before and after trial of a workplace physical activity programme. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- High-intensity Interval Training
- What is being tested?
- High-intensity interval training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Apr 2018to 31 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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+)
Who cannot join
- Exclusion criteria are: Individuals who are not cleared for exercise participation via the PARQ+ will not be eligible to participate. Additionally those unable or unwilling to give informed consent, have any diagnosis or symptoms of cardiovascular or metabolic disease (such as history of heart attack, stroke or diabetes), have been advised by a health professional to avoid physical exercise or activity, are pregnant or might be pregnant and cannot understand and speak English will not be eligible to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BE@Work: A Pilot Controlled Before and After Trial of a Workplace Physical Activity Programme.
BE@Work (Brief Exercise at Work) is a pilot controlled before and after trial of a workplace physical activity programme.
Read the detailed description
The aim of this study is to investigate the effect of an 8 week workplace physical activity programme on various markers of physical fitness, cardiometabolic health and wellbeing of employees. The primary outcome measures are the following: aerobic fitness, grip strength, leg extensor power, blood pressure, fasting blood glucose levels, lipid profiles, body mass index, waist and hip circumference and self-report measures of psychological wellbeing. The secondary outcome measure is total physical activity. The primary and secondary outcomes measures will be assessed in the control and intervention groups at baseline and at the end of the intervention (8 weeks).
- Conditions
- High-intensity Interval Training
- Being tested
- High-intensity interval training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval trainingBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Behavioral: High-intensity interval training |
| Control | No intervention | Outcome measures only at baseline at follow-up (8 weeks) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (1)
Accelerometer assessed habitual physical activity
Measurement of habitual physical activity over a 7 day period will be assessed using a Uniaxial Actigraph accelorometer (GT1M model, Actigraph, LLC, Pensacola, Florida). The participant will wear a small hip mounted accelerometer to assess their habitual physical activity for 7 days following their baseline data collection.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start9 Apr 2018
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-intensity Interval TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teesside University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naomi Burn, Teesside University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03467594
- Sponsor's protocol ID
- 036/18
- Status last verified
- Apr 2019
- First submitted
- 5 Mar 2018
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BE@Work: A Pilot Controlled Before and After Trial of a Workplace Physical Activity Programme.
- ClinicalTrials.gov ID
- NCT03467594
- Acronym / sponsor ID
- 036/18
- Conditions
- High-intensity Interval Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Teesside UniversityUniversity, hospital or other
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 16 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
BE@Work (Brief Exercise at Work) is a pilot controlled before and after trial of a workplace physical activity programme.
Detailed description
The aim of this study is to investigate the effect of an 8 week workplace physical activity programme on various markers of physical fitness, cardiometabolic health and wellbeing of employees. The primary outcome measures are the following: aerobic fitness, grip strength, leg extensor power, blood pressure, fasting blood glucose levels, lipid profiles, body mass index, waist and hip circumference and self-report measures of psychological wellbeing. The secondary outcome measure is total physical activity. The primary and secondary outcomes measures will be assessed in the control and intervention groups at baseline and at the end of the intervention (8 weeks).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: High-intensity interval training8 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) |
| Control | No intervention | –Outcome measures only at baseline at follow-up (8 weeks) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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+)
Key exclusion criteria (1 listed)
- Exclusion criteria are: Individuals who are not cleared for exercise participation via the PARQ+ will not be eligible to participate. Additionally those unable or unwilling to give informed consent, have any diagnosis or symptoms of cardiovascular or metabolic disease (such as history of heart attack, stroke or diabetes), have been advised by a health professional to avoid physical exercise or activity, are pregnant or might be pregnant and cannot understand and speak English will not be eligible to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity interval training• 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. | Behavioural | Intervention arm |
Primary outcome
Aerobic fitness
Time frame: 8 weeks
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).
Alternative measure of aerobic fitness
Time frame: 8 weeks
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).
Hand grip strength
Time frame: 8 weeks
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.
Leg extensor power
Time frame: 8 weeks
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.
Resting blood pressure
Time frame: 8 weeks
Resting blood pressure will be measured using an electronic blood pressure monitor (Omron, M6 AC ME, Omron Healthcare, Kyoto, Japan).
Blood lipid concentration
Time frame: 8 weeks
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.
Body Mass Index
Time frame: 8 weeks
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.
Health related quality of life
Time frame: 8 weeks
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.
Mental wellbeing
Time frame: 8 weeks
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.
Stress
Time frame: 8 weeks
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.
Blood glucose concentration
Time frame: 8 weeks
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.
Waist circumference
Time frame: 8 weeks
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.
1 secondary outcome
Accelerometer assessed habitual physical activity
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity interval training in people with High-intensity Interval Training, run by Teesside University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aerobic fitness (time frame: 8 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2019.