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出境医 / 临床实验 / Effectiveness of a Novel Workplace-based Exercise Intervention: a Pilot Study

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

Study Description
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).

Condition or disease Intervention/treatment Phase
Health Behavior Behavioral: Reduced-Exertion High-Intensity Interval Training (REHIT) Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: RCT
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of a Novel Workplace-based Exercise Intervention: a Pilot Study
Actual Study Start Date : May 1, 2019
Actual Primary Completion Date : September 13, 2019
Actual Study Completion Date : November 13, 2019
Arms and Interventions
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.
 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.
Outcome Measures
Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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').


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Locations
Layout table for location information
United Kingdom
Stirling Council
Stirling, United Kingdom, FK49LA
Sponsors and Collaborators
University of Stirling
Swansea University
Tracking Information
First Submitted Date  ICMJE April 26, 2019
First Posted Date  ICMJE May 7, 2019
Last Update Posted Date March 24, 2020
Actual Study Start Date  ICMJE May 1, 2019
Actual Primary Completion Date September 13, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2019) 		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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2019)
  • 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 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 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.
  • 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').
Original Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2019)
  • 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
  • Change in health status [ Time Frame: Change from baseline to 3 days after the 6-week intervention ]
    Health status as assessed using the SF36 questionnaire
  • 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
  • Intervention acceptability [ Time Frame: 3 days after the 6-week intervention ]
    Intervention acceptability as assessed using a questionnaire published by Boereboom et al (2016).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of a Novel Workplace-based Exercise Intervention: a Pilot Study
Official Title  ICMJE Effectiveness of a Novel Workplace-based Exercise Intervention: a Pilot Study
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
RCT
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Health Behavior
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Reduced-Exertion High-Intensity Interval Training (REHIT)
  • No Intervention: Control
    The effects of the intervention will be compared to a no-intervention control group recruited from the same workplace settings.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 23, 2020) 		23
Original Estimated Enrollment  ICMJE
 (submitted: May 5, 2019) 		50
Actual Study Completion Date  ICMJE November 13, 2019
Actual Primary Completion Date September 13, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03941145
Other Study ID Numbers  ICMJE 18/19 036
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: data will be disseminated / published as means +- SD. no individual data will be presented.
Responsible Party Niels Vollaard, University of Stirling
Study Sponsor  ICMJE University of Stirling
Collaborators  ICMJE Swansea University
Investigators  ICMJE Not Provided
PRS Account University of Stirling
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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