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

Health Promotion Clinical Trial

— WORK-HIIT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04065191
• Other study ID #: WORK-HIIT-Study
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: April 30, 2022

Study information

• Verified date: August 2019
• Source: University of Erlangen-Nürnberg Medical School
• Contact: Dejan Reljic, Dr.
• Phone: +49 9131 8545218
• Email: dejan.reljic[@]uk-erlangen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 subjective work ability in previously sedentary employees.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Health Promotion
• Primary Prevention

Intervention

Other:
• High-intensity interval training
Heart rate based high-intensity interval training

Locations

Country	Name	City	State
Germany	Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg	Erlangen

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiorespiratory Fitness (CRF)	CRF will be assessed by measuring maximum oxygen uptake (VO2max)	12 months [Change from Baseline to 6 months and Change from Baseline to 6 months after the end of the intervention]
Secondary	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.	12 months [Change from Baseline to 6 months and Change from Baseline to 6 months after the end of the intervention]
Secondary	Muscle mass	Muscle mass (kg) will be measured by Bioelectrical Impedance Analysis (BIA)	12 months [Change from Baseline to 6 months and Change from baseline to 6 months after the end of the intervention]
Secondary	Fat mass	Fat mass (kg) will be measured by Bioelectrical Impedance Analysis (BIA)	12 months [Change from baseline to 6 months and change from baseline to 6 months after the end of the intervention]
Secondary	Total body water	Total body water (l) will be measured by Bioelectrical Impedance Analysis (BIA)	12 months [Change from baseline to 6 months and change from baseline to 6 months after the end of the intervention]
Secondary	Insulin sensitivity	Insulin sensitivity will be estimated using homeostasis model assessment index (HOMA)	12 months [Change from Baseline to 6 months and Change from Baseline to 6 months after the end of the intervention]
Secondary	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)	12 months [Change from Baseline to 6 months and Change from Baseline to 6 months after the end of the intervention]
Secondary	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).	12 months [Change from Baseline to 6 months and Change from Baseline to 6 months after the end of the intervention]
Secondary	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).	12 months [Change from Baseline to 6 months and Change from Baseline to 6 months after the end of the intervention]
Secondary	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.	12 months [Change from Baseline to 6 months and Change from Baseline to 6 months after the end of the intervention]
Secondary	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).	12 months [Change from Baseline to 6 months and Change from Baseline to 6 months after the end of the intervention]