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.
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
- 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
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.
- Conditions
- Primary Prevention, Health Promotion
- 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 group | Role | What they receive |
|---|---|---|
| High-intensity interval training | Experimental | High-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.
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)
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]
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]
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]
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]
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]
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]
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]
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]
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]
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.
- First posted22 Aug 2019
- Study start1 May 2019
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary PreventionStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dejan Reljic, Dr., Principal investigator, University Erlangen Nuremberg Medical SchoolYurdaguel Zopf, Prof., Principal investigator, University Erlangen Nuremberg Medical School
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-intensity Interval Training for Workplace Health Promotion: Evaluation of Feasibility and Preventive Effects in a Real-World Setting
- ClinicalTrials.gov ID
- NCT04065191
- Acronym / sponsor ID
- WORK-HIIT / WORK-HIIT-Study
- Conditions
- Primary Prevention, Health Promotion
- Keywords
- Aerobic exercise, Cardiorespiratory Fitness, High-intensity interval training (HIIT), Workability, Prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 22 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-intensity interval training | Experimental | Other: High-intensity interval trainingHigh-intensity interval training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Sedentary Lifestyle over at least 1 year prior to the study
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity interval trainingHeart rate based high-intensity interval training | Other | High-intensity interval training |
Primary outcome
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]
CRF will be assessed by measuring maximum oxygen uptake (VO2max)
10 secondary outcomes
Metabolic Syndrome Z-Score (MetS-Z-Score)
Time frame: 12 months [Change from Baseline to 6 months and Change from Baseline to 6 months after the end of the intervention]
Muscle mass
Time frame: 12 months [Change from Baseline to 6 months and Change from baseline to 6 months after the end of the intervention]
Fat mass
Time frame: 12 months [Change from baseline to 6 months and change from baseline to 6 months after the end of the intervention]
Total body water
Time frame: 12 months [Change from baseline to 6 months and change from baseline to 6 months after the end of the intervention]
Insulin sensitivity
Time frame: 12 months [Change from Baseline to 6 months and Change from Baseline to 6 months after the end of the intervention]
Inflammation status
Time frame: 12 months [Change from Baseline to 6 months and Change from Baseline to 6 months after the end of the intervention]
Health-related quality of life
Time frame: 12 months [Change from Baseline to 6 months and Change from Baseline to 6 months after the end of the intervention]
Pain scores
Time frame: 12 months [Change from Baseline to 6 months and Change from Baseline to 6 months after the end of the intervention]
Perceived stress
Time frame: 12 months [Change from Baseline to 6 months and Change from Baseline to 6 months after the end of the intervention]
Subjective work ability
Time frame: 12 months [Change from Baseline to 6 months and Change from Baseline to 6 months after the end of the intervention]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dejan Reljic, Dr. principal investigator
University Erlangen Nuremberg Medical School
Yurdaguel Zopf, Prof. principal investigator
University Erlangen Nuremberg Medical School
1 site in 1 country: see every site and its status.
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.