Health Promotion Clinical Trial
— WORK-HIITOfficial 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.
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg | Erlangen |
Lead Sponsor | Collaborator |
---|---|
University of Erlangen-Nürnberg Medical School |
Germany,
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] |
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