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

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ClinicalTrials.gov Identifier: NCT04065191
Recruitment Status : Recruiting
First Posted : August 22, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

Brief 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 subjective work ability in previously sedentary employees.

Condition or disease Intervention/treatment Phase
Primary Prevention Health Promotion Other: High-intensity interval training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: High-intensity Interval Training for Workplace Health Promotion: Evaluation of Feasibility and Preventive Effects in a Real-World Setting
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2022

Arm Intervention/treatment
Experimental: High-intensity interval training
High-intensity interval training
Other: High-intensity interval training
Heart rate based high-intensity interval training




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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] ]
    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.

  2. 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] ]
    Muscle mass (kg) will be measured by Bioelectrical Impedance Analysis (BIA)

  3. 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] ]
    Fat mass (kg) will be measured by Bioelectrical Impedance Analysis (BIA)

  4. 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] ]
    Total body water (l) will be measured by Bioelectrical Impedance Analysis (BIA)

  5. 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] ]
    Insulin sensitivity will be estimated using homeostasis model assessment index (HOMA)

  6. 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] ]
    Inflammation status will be assessed by measuring blood levels (mg/L) of c-reactive protein (CRP) and high-sensitivity c-reactive protein (hs-CRP)

  7. 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] ]
    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).

  8. 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] ]

    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).


  9. 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] ]
    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.

  10. 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] ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065191


Contacts
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Contact: Dejan Reljic, Dr. +49 9131 8545218 dejan.reljic@uk-erlangen.de
Contact: Yurdaguel Zopf, Prof. +49 9131 8545218 yurdaguel.zopf@uk-erlangen.de

Locations
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Germany
Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg Recruiting
Erlangen, Germany, 91052
Contact: Dejan Reljic, Dr.    +49 9131 8545218    dejan.reljic@uk-erlangen.de   
Contact: Yurdaguel Zopf, Prof.    +49 9131 8545218    yurdaguel.zopf@uk-erlangen.de   
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
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Principal Investigator: Dejan Reljic, Dr. University Erlangen Nuremberg Medical School
Principal Investigator: Yurdaguel Zopf, Prof. University Erlangen Nuremberg Medical School

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Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT04065191     History of Changes
Other Study ID Numbers: WORK-HIIT-Study
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Erlangen-Nürnberg Medical School:
Aerobic exercise
Cardiorespiratory Fitness
High-intensity interval training (HIIT)
Workability
Prevention