- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04065191
Workplace HIIT: Feasibility and Preventive Effects of HIIT in the Real-World (WORK-HIIT)
High-intensity Interval Training for Workplace Health Promotion: Evaluation of Feasibility and Preventive Effects in a Real-World Setting
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Erlangen, Germany, 91052
- Recruiting
- Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High-intensity interval training
|
Heart rate based high-intensity interval training
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
12 months [Change from Baseline to 6 months and Change from Baseline to 6 months after the end of the intervention]
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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]
|
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]
|
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)
|
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]
|
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]
|
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)
|
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]
|
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]
|
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).
|
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]
|
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]
|
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.
|
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]
|
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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12 months [Change from Baseline to 6 months and Change from Baseline to 6 months after the end of the intervention]
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- WORK-HIIT-Study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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