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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
No Intervention: Control
The effects of the intervention will be compared to a no-intervention control group recruited from the same workplace settings.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Change from baseline to 3 days after the 6-week intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
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
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
Change in perceived stress
Time Frame: Change from baseline to 3 days after the 6-week intervention
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
Intervention acceptability
Time Frame: 3 days after the 6-week intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Stirling

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Swansea University

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 13, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 13, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 7, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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