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Primary PreventionWORK-HIITNCT04065191

Workplace HIIT: Feasibility and Preventive Effects of HIIT in the Real-World

A study testing High-intensity interval training in people with Primary Prevention and Health Promotion, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study is to investigate the effects of an extremely time-efficient high-intensity interval training program, performed over a period of six months in a real-world (workplace) setting, on cardiorespiratory fitness, cardiometabolic risk profile, and self-reported outcomes including perceived stress and… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Primary Prevention, Health Promotion
What is being tested?
High-intensity interval training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteGermany
Study dates
1 May 2019to 30 Apr 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Sedentary Lifestyle over at least 1 year prior to the study

Who cannot join

  • Pregnancy, Lactation
  • Psychological disorders, epilepsy, sever neurological disorders
  • Participation in other exercise- or nutrition studies within the last 6 months
  • coronary heart disease, heart failure
  • malignant disease
  • severe rheumatic or neurological disease
Show all 13Show fewer
  • severe/unstable hypertension (resting RR: >180/>110 mmHg)
  • severely restricted lung function (FEV1 <60%)
  • unstable Diabetes mellitus
  • severe orthopedic disease/restriction
  • acute / chronic infectious diseases
  • Electronic implants (defibrillator, pacemaker)
  • Persons in mental hospitals by order of authorities or jurisdiction

Trial locations and contacts

1 site in 1 country.

Germany1 site, 1 recruiting
  • Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg

    Erlangen, 91052

    Dejan Reljic, Dr., +49 9131 8545218, dejan.reljic@uk-erlangen.de

    Yurdaguel Zopf, Prof., +49 9131 8545218, yurdaguel.zopf@uk-erlangen.de

    Recruiting

Other trials in Germany

About this study

Official title: High-intensity Interval Training for Workplace Health Promotion: Evaluation of Feasibility and Preventive Effects in a Real-World Setting

The aim of this study is to investigate the effects of an extremely time-efficient high-intensity interval training program, performed over a period of six months in a real-world (workplace) setting, on cardiorespiratory fitness, cardiometabolic risk profile, and self-reported outcomes including perceived stress and subjective work ability in previously sedentary employees.

Being tested
High-intensity interval training
Keywords
Aerobic exercise, Cardiorespiratory Fitness, High-intensity interval training (HIIT), Workability, Prevention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-intensity interval trainingOther

    Heart rate based high-intensity interval training

Study groups in NCT04065191
Study groupRoleWhat they receive
High-intensity interval trainingExperimentalHigh-intensity interval training
Receives: Other: High-intensity interval training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiorespiratory Fitness (CRF)

    CRF will be assessed by measuring maximum oxygen uptake (VO2max)

    Measured: 12 months [Change from Baseline to 6 months and Change from Baseline to 6 months after the end of the intervention]

Secondary outcomes (10)
  1. Metabolic Syndrome Z-Score (MetS-Z-Score)

    MetS-Z-Score will be calculated from each individual's measures of waist circumference (cm), mean arterial blood pressure (mmHg), Glucose (mg/dL), triglycerides (mg/dL), and HDL-cholesterol (mg/dL), based on equations specific to sex.

    Measured: 12 months [Change from Baseline to 6 months and Change from Baseline to 6 months after the end of the intervention]

  2. Muscle mass

    Muscle mass (kg) will be measured by Bioelectrical Impedance Analysis (BIA)

    Measured: 12 months [Change from Baseline to 6 months and Change from baseline to 6 months after the end of the intervention]

  3. Fat mass

    Fat mass (kg) will be measured by Bioelectrical Impedance Analysis (BIA)

    Measured: 12 months [Change from baseline to 6 months and change from baseline to 6 months after the end of the intervention]

  4. Total body water

    Total body water (l) will be measured by Bioelectrical Impedance Analysis (BIA)

    Measured: 12 months [Change from baseline to 6 months and change from baseline to 6 months after the end of the intervention]

  5. Insulin sensitivity

    Insulin sensitivity will be estimated using homeostasis model assessment index (HOMA)

    Measured: 12 months [Change from Baseline to 6 months and Change from Baseline to 6 months after the end of the intervention]

  6. Inflammation status

    Inflammation status will be assessed by measuring blood levels (mg/L) of c-reactive protein (CRP) and high-sensitivity c-reactive protein (hs-CRP)

    Measured: 12 months [Change from Baseline to 6 months and Change from Baseline to 6 months after the end of the intervention]

  7. Health-related quality of life

    Health-related quality of life will be assessed by using the standardized and validated EQ-5D-5L Questionnaire, consisting of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient ticks the box next to the most appropriate statement in each dimension (scale: 1-5; lower value = better outcome). The digits for the 5 dimensions can be combined into a 5-digit number that describes the patient's health state.The EQ VAS records the patient's self-rated health on a vertical visual analogue scale (0-100, higher value = better outcome).

    Measured: 12 months [Change from Baseline to 6 months and Change from Baseline to 6 months after the end of the intervention]

  8. Pain scores

    Pain scores will be assessed by using the standardized and validated Chronic Pain Grade Questionnaire (CPGQ). The CPGQ is a seven-item instrument to evaluate overall severity of chronic pain based on 2 dimensions: pain intensity and pain-related disability. The responses on the 7 items are used to compute scores for 3 subscales: pain intensity (0-100), disability score (0-3), and disability Points (0-3). Lower values indicate better outcomes.

    moderately limiting intensity (Grade III), high disability and severely limiting intensity (Grade IV) (see Von Korff et al 1992).

    Measured: 12 months [Change from Baseline to 6 months and Change from Baseline to 6 months after the end of the intervention]

  9. Perceived stress

    Perceived stress will be assessed by using the standardized and validated Perceived Stress Questionnaire (PSQ). The PSQ comprises different components of stress (worries, tension, joy, demands), with 5 items each. It contains both positively and negatively formulated items in order to reduce acquiescent bias. Each item is answered using a four-point Likert-type scale, ranging from 1 to 4. Higher scores indicate more severe perceived stress.

    Measured: 12 months [Change from Baseline to 6 months and Change from Baseline to 6 months after the end of the intervention]

  10. Subjective work ability

    Subjective work ability will be assessed by using the standardized and validated Work Ability Index Questionnaire (WAI). WAI obtains information related to diseases, functional limitations, sick leave, and mental resources. The questionnaire consistes of 7 items, including current work ability compared with the lifetime best (item 1, 0-10), work ability in relation to the demands of the job (item 2, 2-10), number of current disease groups diagnosed by a physician (item 3, 1-7), estimated work impairment due to diseases (item 4, 1-6), sick leave during the past year (item 5, 1-5), personal prognosis of work ability for 2 years from now (item 6, 1,4 or 7) and mental resources, referring to the workers life in general, both at work and during leisure time(item 7, 1-4). The total WAI score is calculated by summing up the scores of all items and is ranged from 7 to 49. The total WAI scores are categorized into 4 levels: poor (7-27), moderate (28-36), good (37-43), and excellent (44-49).

    Measured: 12 months [Change from Baseline to 6 months and Change from Baseline to 6 months after the end of the intervention]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2019
  2. Study start1 May 2019
  3. Primary completion30 Apr 2022 (estimated)
  4. Study completion30 Apr 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04065191
Sponsor's protocol ID
WORK-HIIT-Study
Acronym
WORK-HIIT
Status last verified
Aug 2019
First submitted
15 May 2019
Last updated
22 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing High-intensity interval training in people with Primary Prevention and Health Promotion, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dejan Reljic, Dr. (+49 9131 8545218, dejan.reljic@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiorespiratory Fitness (CRF) (time frame: 12 months [Change from Baseline to 6 months and Change from Baseline to 6 months after the end of the intervention]). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2019.

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