Cardiovascular Diseases Clinical Trial
— TurnistiOfficial title:
Effects of Shift Work on Health: Assessment of Sleep Quality, Motor Control and Cardiovascular Risk.
Verified date | January 2020 |
Source | Istituto Ortopedico Galeazzi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Shift work deeply impacts on temporal organization leading to a circadian desynchronization,
which translates into a worsening of the sleep quality and work ability during waking hours.
Furthermore, also the fine motor control skills and the subjective mood profile could undergo
modifications in relation to the acquired sleep debt. The misalignment between working time
and physiological/behavioral functions could have negative influences on the levels of
spontaneous daily activity, with possible alteration of the activity-rest rhythm of the
worker, especially in clinics.
In relation to the participants' chronotype, the aim of this project will be to evaluate the
effect of irregular working hours (shift work) on (i) the sleep quality, (ii) the circadian
rhythm of activity levels and, (iii) the motor control. These assessments will help to
identify the shift type with less impact on the health status in a nurse cohort.
Status | Completed |
Enrollment | 71 |
Est. completion date | January 15, 2020 |
Est. primary completion date | December 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Work shift continuity in a specific group of at least one year. Exclusion Criteria: - Presence of cardiovascular, endocrine or metabolic diseases; - Presence of neurological or musculoskeletal impairments at finger flexors muscles level; - Pharmacological therapies in place that can affect the heart rate and the sleep quality; - Self-declaration of pregnancy. |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Istituto Ortopedico Galeazzi | Milan | MI |
Lead Sponsor | Collaborator |
---|---|
Istituto Ortopedico Galeazzi |
Italy,
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* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ) | Questionnaire for chronotype determination.The MEQ has 19 items, and the answer options include using a visual analog scale and choosing between four or five options. Participants are classified as Morning-types (scores between 59 and 86), Neither-types (scores between 42 and 58), and Evening-types (scores between 16 and 41). | Baseline | |
Other | International Physical Activity Questionnaire (IPAQ) | Questionnaire for the assessment of the level of physical activity. The number of days and minutes in a week dedicated at walking or in moderate or heavy physical activities are converted in metabolic equivalent units (METs). The sum of the METs identifies the level of physical activity: METs < 700 = inactive; METs from 700 to 2519 = adequately active; METs > 2519 highly active. | Baseline | |
Other | QRISK2-2017 questionnaire | Questionnaire for cardiovascular risk assessment. The questionnaire provides a score (in percentage) of the risk of having a heart attack or stroke within the next 10 years. Score ranges from 0.1% (lowest risk) and 100% (maximum risk). | Baseline | |
Primary | Sleep Efficiency (SE) | Percentage of time spent in bed with actual sleep | 8 days | |
Primary | Sleep Latency (SL) | period of time between bed and sleep | 8 days | |
Primary | Movement and Fragmentation Index (MFI) | Percentage of time spent moving indicative of the fragmentation of sleep | 8 days | |
Primary | Immobile Time (IT) | total time spent without movement, between sleep from start to sleep | 8 days | |
Primary | Assumed Sleep (AS) | Difference between beginning and end of sleep | 8 days | |
Secondary | Profile of Mood States (POMS) | Questionnaire for the determination of the mood profile | Baseline and 8 days | |
Secondary | Finger flexor muscles maximum voluntary contraction (MVC) | Evaluation of the maximum isometric force output of the finger flexors muscles | Baseline and 8 days | |
Secondary | Force coefficient of variation (CV) | Ratio between the standard deviation of the force signal during the plateau phase and the mean of the force signal (index of muscle contraction stability) | Baseline and 8 days | |
Secondary | Distance of the force signal (DF) | distance of the force signal with respect to the target (index of force accuracy ) | Baseline and 8 days | |
Secondary | Surface electromyography (sEMG) root mean square (RMS) of finger flexor muscles | Index of muscle activation reflecting the number of recruited motor units during contraction | Baseline and 8 days | |
Secondary | Surface electromyography (sEMG) mean frequency (MF) of finger flexor muscles | Index reflecting the mean rate of activation of the recruited motor units during contraction | Baseline and 8 days | |
Secondary | Hearth Rate Variability (HRV) | Quantification of the sympatho-vagal balance | Baseline and 8 days |
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