Health BehaviorNCT03941145
Effectiveness of a Novel Workplace-based Exercise Intervention: a Pilot Study
A study testing Reduced-Exertion High-Intensity Interval Training (REHIT) in people with Health Behavior, run by University of Stirling at 1 site in United Kingdom.
Trial summary
Sufficient physical activity and a good cardiorespiratory fitness level (CRF) are central in cardiovascular disease (CVD) risk reduction. However, many people remain inactive, partly because current exercise recommendations fail to address important barriers to exercise. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Reduced-Exertion High-Intensity Interval Training (REHIT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2019to 13 Nov 2019
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Employee at participating workplace
Who cannot join
- Aged < 18 years or > 60 years
- History of type 2 diabetes
- Insulin therapy
- Use of β-blockers
- Use of inhaled steroids (e.g. for asthma)
- Any cardiovascular condition with the exception of well-controlled uncomplicated hypertension (systolic >140 mm Hg and/or >90 mm Hg after at least 5 minutes of seated rest), which is treated with no more than two drugs (either an ACE, ARB, calcium channel blocker, or diuretic)
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- Cerebrovascular disease including previous stroke or aneurysm
- History of exercise-induced asthma
- History of type 1 diabetes mellitus or a history of ketoacidosis
- History of other specific types of diabetes (e.g., genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug or chemical-induced, and post organ transplant)
- History of respiratory disease including pulmonary hypertension or chronic obstructive pulmonary disease
- History of musculoskeletal or neurological disorders
- Active inflammatory bowel disease
- History of renal disease
- Other metabolic diseases, including hyper/ hypo-parathyroidism, hyper/hypo-thyroidism, and Cushing's disease.
- BMI>35 kg/m2
- A clinically significant resting ECG abnormality at the pre-screening visit which in the opinion of the cardiologist exposes the participant to risk by take part in the main trial.
- 'Yes' to any questions on a standard physical activity readiness questionnaire (PARQ)
- Classification as moderately or highly physically active on the International Physical Activity Questionnaire (IPAQ)
- Current participation in another research study
- Inability to fully understand the verbal and written descriptions of the study in English, and the instructions provided during the study
Trial locations and contacts
1 site in 1 country.
About this study
Sufficient physical activity and a good cardiorespiratory fitness level (CRF) are central in cardiovascular disease (CVD) risk reduction. However, many people remain inactive, partly because current exercise recommendations fail to address important barriers to exercise. A novel exercise protocol has previously been developed called 'reduced-exertion high-intensity interval training' (REHIT), which can remove several common perceived barriers to exercise. REHIT 1) improves CRF and other key CVD risk factors, 2) is genuinely time-efficient (total time-commitment of just 2x10 min per week), 3) is well-tolerated, manageable, and not associated with negative affective responses, and 4) can be done in the workplace, in work-clothes and without a need to shower afterwards. To date, this intervention has only been investigated in a lab-setting. Therefore, in the present randomised controlled trial, the 'real-world' effectiveness of REHIT in improving maximal aerobic capacity (V̇O2max; a key risk factors of CVD) will be investigated in a workplace setting. Participants' attitudes and psychological responses to REHIT will be assessed to evaluate the likelihood of successful implementation. In 2 study centres, a total of up to n=50 physically inactive male and female office workers will be recruited to perform 6 weeks of unsupervised, computer-guided, office-based REHIT (n=25) or act as a control (n=25).
- Conditions
- Health Behavior
- Being tested
- Reduced-Exertion High-Intensity Interval Training (REHIT)
- Keywords
- exercise
- Medical subject headings
- Health Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced-Exertion High-Intensity Interval Training (REHIT)Behavioural
REHIT is a type of Sprint Interval Training (SIT) that has been shown to be efficacious at improving maximal aerobic capacity using a minimal volume of exercise.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Participants allocated to the intervention group will be asked to perform 2 exercise sessions per week for 6 weeks. Each session will involve 10 min of low-intensity cycling (25 W) interspersed with two 20-s 'all-out' cycle sprints against a resistance equivalent to 5% of body mass. The exercise intervention will be delivered on a commercially available cycle ergometer with software developed by CAR.O.L. Receives: Behavioral: Reduced-Exertion High-Intensity Interval Training (REHIT) |
| Control | No intervention | The effects of the intervention will be compared to a no-intervention control group recruited from the same workplace settings. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximal aerobic capacity
Aerobic capacity: a key risk factor of noncommunicable disease
Measured: Change from baseline to 3 days after the 6-week intervention
Secondary outcomes (4)
Change in motivation for exercise
Motivation to exercise as assessed using the RM 4-FM questionnaire, a 16-item questionnaire assessing reasons for trying to be physically active on a scale from 1 ('not at all true') to 7 ('very true'). Higher scores indicate a greater motivation for performing exercise. Scores are added to get an overall score, with higher overall scores indicating greater intrinsic motivation.
Measured: Change from baseline to 3 days after the 6-week intervention
Change in health status
Health status as assessed using the Short Form (36) Health Survey (SF36), which is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: Change from baseline to 3 days after the 6-week intervention
Change in perceived stress
Perceived stress as assessed using the Perceived Stress Scale questionnaire, which measures the degree to which situations in one's life are appraised as stressful. The 10-item questionnaire ask for the frequency of stressful events in the last month, scored on a scale from 0 ('never') to 4 ('very often'). The sum score is taken, with higher scores indicating more perceived stress.
Measured: Change from baseline to 3 days after the 6-week intervention
Intervention acceptability
Intervention acceptability as assessed using a questionnaire published by Boereboom et al (2016). This 11-item questionnaire asks how strongly participants agree with statements on the acceptability of the exercise intervention on a scale from 1 ('strongly disagree') to 5 ('strongly agree').
Measured: 3 days after the 6-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start1 May 2019
- Primary completion13 Sep 2019
- Study completion13 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Stirling
- Sponsor type
- University, hospital or other
- Collaborators
- Swansea University
- Responsible party
- Principal investigator, Niels Vollaard, University of Stirling
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03941145
- Sponsor's protocol ID
- 18/19 036
- Status last verified
- Mar 2020
- First submitted
- 26 Apr 2019
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data will be disseminated / published as means +- SD. no individual data will be presented.
Publications
Metcalfe RS, Atef H, Mackintosh K, McNarry M, Ryde G, Hill DM, Vollaard NBJ. Time-efficient and computer-guided sprint interval exercise training for improving health in the workplace: a randomised mixed-methods feasibility study in office-based employees. BMC Public Health. 2020 Mar 12;20(1):313. doi: 10.1186/s12889-020-8444-z.
PubMed 32164631
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Novel Workplace-based Exercise Intervention: a Pilot Study
- ClinicalTrials.gov ID
- NCT03941145
- Acronym / sponsor ID
- 18/19 036
- Conditions
- Health Behavior
- Keywords
- exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of StirlingUniversity, hospital or other
- Collaborators
- Swansea University
- Study start
- 1 May 2019 (actual)
- Primary completion
- 13 Sep 2019 (actual)
- Study completion
- 13 Nov 2019 (actual)
- First posted
- 7 May 2019 (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.
Sufficient physical activity and a good cardiorespiratory fitness level (CRF) are central in cardiovascular disease (CVD) risk reduction. However, many people remain inactive, partly because current exercise recommendations fail to address important barriers to exercise. A novel exercise protocol has previously been developed called 'reduced-exertion high-intensity interval training' (REHIT), which can remove several common perceived barriers to exercise. REHIT 1) improves CRF and other key CVD risk factors, 2) is genuinely time-efficient (total time-commitment of just 2x10 min per week), 3) is well-tolerated, manageable, and not associated with negative affective responses, and 4) can be done in the workplace, in work-clothes and without a need to shower afterwards. To date, this intervention has only been investigated in a lab-setting. Therefore, in the present randomised controlled trial, the 'real-world' effectiveness of REHIT in improving maximal aerobic capacity (V̇O2max; a key risk factors of CVD) will be investigated in a workplace setting. Participants' attitudes and psychological responses to REHIT will be assessed to evaluate the likelihood of successful implementation. In 2 study centres, a total of up to n=50 physically inactive male and female office workers will be recruited to perform 6 weeks of unsupervised, computer-guided, office-based REHIT (n=25) or act as a control (n=25).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Reduced-Exertion High-Intensity Interval Training (REHIT)Participants allocated to the intervention group will be asked to perform 2 exercise sessions per week for 6 weeks. Each session will involve 10 min of low-intensity cycling (25 W) interspersed with two 20-s 'all-out' cycle sprints against a resistance equivalent to 5% of body mass. The exercise intervention will be delivered on a commercially available cycle ergometer with software developed by CAR.O.L. |
| Control | No intervention | –The effects of the intervention will be compared to a no-intervention control group recruited from the same workplace settings. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Employee at participating workplace
Key exclusion criteria (21 listed)
- Aged < 18 years or > 60 years
- History of type 2 diabetes
- Insulin therapy
- Use of β-blockers
- Use of inhaled steroids (e.g. for asthma)
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 |
|---|---|---|
| Reduced-Exertion High-Intensity Interval Training (REHIT)REHIT is a type of Sprint Interval Training (SIT) that has been shown to be efficacious at improving maximal aerobic capacity using a minimal volume of exercise. | Behavioural | Exercise |
Primary outcome
Change in maximal aerobic capacity
Time frame: Change from baseline to 3 days after the 6-week intervention
Aerobic capacity: a key risk factor of noncommunicable disease
4 secondary outcomes
Change in motivation for exercise
Time frame: Change from baseline to 3 days after the 6-week intervention
Change in health status
Time frame: Change from baseline to 3 days after the 6-week intervention
Change in perceived stress
Time frame: Change from baseline to 3 days after the 6-week intervention
Intervention acceptability
Time frame: 3 days after the 6-week intervention
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 24 Mar 2020.
- Derived from this study: PubMed 32164631Metcalfe RS, Atef H, Mackintosh K, McNarry M, Ryde G, Hill DM, Vollaard NBJ. Time-efficient and computer-guided sprint interval exercise training for improving health in the workplace: a randomised mixed-methods feasibility study in office-based employees. BMC Public Health. 2020 Mar 12;20(1):313. doi: 10.1186/s12889-020-8444-z.
- Individual participant dataSharing planned: No. data will be disseminated / published as means +- SD. no individual data will be presented.
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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 Reduced-Exertion High-Intensity Interval Training (REHIT) in people with Health Behavior, run by University of Stirling 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 21 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 24 Mar 2020. 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?
Change in maximal aerobic capacity (time frame: Change from baseline to 3 days after the 6-week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03941145, which also lists 1 linked publication.
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 24 Mar 2020.