NCT03941145

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 7, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2019

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

5 months

First QC Date

April 26, 2019

Last Update Submit

March 23, 2020

Conditions

Keywords

exercise

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in motivation for exercise

    Change from baseline to 3 days after the 6-week intervention

  • Change in health status

    Change from baseline to 3 days after the 6-week intervention

  • Change in perceived stress

    Change from baseline to 3 days after the 6-week intervention

  • Intervention acceptability

    3 days after the 6-week intervention

Study Arms (2)

Exercise

EXPERIMENTAL

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)

Control

NO INTERVENTION

The effects of the intervention will be compared to a no-intervention control group recruited from the same workplace settings.

Interventions

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.

Exercise

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Employee at participating workplace

You may not qualify if:

  • 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.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stirling Council

Stirling, FK49LA, United Kingdom

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Health BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: RCT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 26, 2019

First Posted

May 7, 2019

Study Start

May 1, 2019

Primary Completion

September 13, 2019

Study Completion

November 13, 2019

Last Updated

March 24, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

data will be disseminated / published as means +- SD. no individual data will be presented.

Locations