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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

Tracking Information
First Submitted Date  ICMJE May 15, 2019
First Posted Date  ICMJE August 22, 2019
Last Update Posted Date August 22, 2019
Actual Study Start Date  ICMJE May 1, 2019
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2019)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2019)
  • 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.
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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).
  • 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).
  • 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.
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Workplace HIIT: Feasibility and Preventive Effects of HIIT in the Real-World
Official Title  ICMJE High-intensity Interval Training for Workplace Health Promotion: Evaluation of Feasibility and Preventive Effects in a Real-World Setting
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Primary Prevention
  • Health Promotion
Intervention  ICMJE Other: High-intensity interval training
Heart rate based high-intensity interval training
Study Arms  ICMJE Experimental: High-intensity interval training
High-intensity interval training
Intervention: Other: High-intensity interval training
Publications * Not Provided

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 20, 2019)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2022
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Dejan Reljic, Dr. +49 9131 8545218 dejan.reljic@uk-erlangen.de
Contact: Yurdaguel Zopf, Prof. +49 9131 8545218 yurdaguel.zopf@uk-erlangen.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04065191
Other Study ID Numbers  ICMJE WORK-HIIT-Study
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 Not Provided
Responsible Party University of Erlangen-Nürnberg Medical School
Study Sponsor  ICMJE University of Erlangen-Nürnberg Medical School
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dejan Reljic, Dr. University Erlangen Nuremberg Medical School
Principal Investigator: Yurdaguel Zopf, Prof. University Erlangen Nuremberg Medical School
PRS Account University of Erlangen-Nürnberg Medical School
Verification Date August 2019

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