Effectiveness of a Novel Workplace-based Exercise Intervention: a Pilot Study

Health Behavior Clinical Trial

Official title:

Effectiveness of a Novel Workplace-based Exercise Intervention: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03941145
• Other study ID #: 18/19 036
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: November 13, 2019

Study information

• Verified date: March 2020
• Source: University of Stirling
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 13, 2019
• Est. primary completion date: September 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Employee at participating workplace

Exclusion Criteria:

• Aged < 18 years or > 60 years

• History of type 2 diabetes

• Insulin therapy

• Use of ß-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

Related Conditions & MeSH terms

• Health Behavior

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United Kingdom	Stirling Council	Stirling

Sponsors (2)

Lead Sponsor	Collaborator
University of Stirling	Swansea University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in maximal aerobic capacity	Aerobic capacity: a key risk factor of noncommunicable disease	Change from baseline to 3 days after the 6-week intervention
Secondary	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.	Change from baseline to 3 days after the 6-week intervention
Secondary	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.	Change from baseline to 3 days after the 6-week intervention
Secondary	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.	Change from baseline to 3 days after the 6-week intervention
Secondary	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').	3 days after the 6-week intervention