- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03941145
Effectiveness of a Novel Workplace-based Exercise Intervention: a Pilot Study
March 23, 2020 updated by: Niels Vollaard, University of Stirling
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Stirling, United Kingdom, FK49LA
- Stirling Council
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
• Employee at participating workplace
Exclusion Criteria:
- 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)
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise
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.
|
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.
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No Intervention: Control
The effects of the intervention will be compared to a no-intervention control group recruited from the same workplace settings.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in maximal aerobic capacity
Time Frame: Change from baseline to 3 days after the 6-week intervention
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Aerobic capacity: a key risk factor of noncommunicable disease
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Change from baseline to 3 days after the 6-week intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in motivation for exercise
Time Frame: Change from baseline to 3 days after the 6-week intervention
|
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.
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Change from baseline to 3 days after the 6-week intervention
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Change in health status
Time Frame: Change from baseline to 3 days after the 6-week intervention
|
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.
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Change from baseline to 3 days after the 6-week intervention
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Change in perceived stress
Time Frame: Change from baseline to 3 days after the 6-week intervention
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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.
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Change from baseline to 3 days after the 6-week intervention
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Intervention acceptability
Time Frame: 3 days after the 6-week intervention
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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').
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3 days after the 6-week intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2019
Primary Completion (Actual)
September 13, 2019
Study Completion (Actual)
November 13, 2019
Study Registration Dates
First Submitted
April 26, 2019
First Submitted That Met QC Criteria
May 5, 2019
First Posted (Actual)
May 7, 2019
Study Record Updates
Last Update Posted (Actual)
March 24, 2020
Last Update Submitted That Met QC Criteria
March 23, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 18/19 036
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
data will be disseminated / published as means +- SD. no individual data will be presented.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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