Clinical trial NCT03941145: Effectiveness of a Novel Workplace-based Exercise Intervention: a Pilot Study
Official title: Effectiveness of a Novel Workplace-based Exercise Intervention: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Keywords: exercise
Lead sponsor: University of Stirling
Sponsor class: OTHER
Collaborators: name: Swansea University
First posted: 2019-05-07
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: TREATMENT

Brief 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. 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).


Eligibility criteria: 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

Primary outcomes:
measure: Change in maximal aerobic capacity
timeFrame: Change from baseline to 3 days after the 6-week intervention
Secondary outcomes:
measure: Change in motivation for exercise
timeFrame: Change from baseline to 3 days after the 6-week intervention
measure: Change in health status
timeFrame: Change from baseline to 3 days after the 6-week intervention
measure: Change in perceived stress
timeFrame: Change from baseline to 3 days after the 6-week intervention
measure: Intervention acceptability
timeFrame: 3 days after the 6-week intervention
Other outcomes:
Locations:
city: Stirling
country: United Kingdom
facility: Stirling Council
Study officials:
References:
citation: 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.