Overview

This trial is active, not recruiting.

Condition healthy night shift workers
Treatments intensive light therapy, exercise
Sponsor Universitätsklinikum Hamburg-Eppendorf
Start date February 2013
End date December 2016
Trial size 216 participants
Trial identifier NCT01767181, EuRhythDia-1

Summary

EuRhythDia is a multicenter, controlled and randomized study. The aim of the study is to investigate the effects of 12 weeks of randomized timed light therapy or timed physical exercise as a chronotherapeutic lifestyle intervention on markers of central and peripheral circadian rhythms and cardiometabolic function in healthy night shift workers.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(No Intervention)
Control group without intervention
(Experimental)
Intensive light therapy during the first half of the night shift
intensive light therapy
Light therapy will be applied by a Lumie Brazil fluorescent tube light box (10.000 lux) during the night shifts for 12 consecutive weeks
(Experimental)
Exercise before the beginning of the night shift
exercise
Physical exercise will be performed in a supervised environment on the days of the night shifts, either before the start of the shift (defined as a time period beginning no earlier than 2 hours before the start of the shift) or after the end of the night shift (defined as a time period ending no longer than 2 hours after the end of the night shift)
(Experimental)
Exercise after the end of the night shift
exercise
Physical exercise will be performed in a supervised environment on the days of the night shifts, either before the start of the shift (defined as a time period beginning no earlier than 2 hours before the start of the shift) or after the end of the night shift (defined as a time period ending no longer than 2 hours after the end of the night shift)

Primary Outcomes

Measure
Efficacy
time frame: 12 weeks

Secondary Outcomes

Measure
Efficacy
time frame: 12 weeks
Efficacy
time frame: 12 weeks
Efficacy
time frame: 12 weeks
Efficacy
time frame: 12 weeks
Efficacy
time frame: 12 weeks
Efficacy
time frame: 12 weeks
Efficacy
time frame: 12 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Male and female subjects above the age of 18 - Night shift workers on regular night shifts with at least 3 nights in a row per month during the study period - Subjects must have been on night shifts for at least 4 weeks before inclusion into the study - Signed written informed consent Exclusion Criteria: - Regular use of drugs (prescription or non-prescription, exception: contraceptives) or dietary supplements within 4 weeks before inclusion of the study - Pregnancy or breast feeding - Any severe somatic or psychic disease (malignant or non-malignant - Any known ophthalmological condition that prevents the exposure to bright light (e.g. cataract, glaucoma, retinopathy, macular degeneration, acute eye infections, lesions of the cornea) - Any skin condition or use of drugs associated with increased photosensitivity; - Any kind of disability that would prevent the subjects from participation in exercise training sessions

Additional Information

Official title Effects of Timed Intensive Light Therapy or Timed Physical Exercise on Markers of Central and Peripheral Circadian Rhythm and on Cardiometabolic Function in Night Shift Workers
Principal investigator Rainer Böger, MD
Description Lifestyle interventions have been recognized as important means to prevent and treat cardiometabolic disease. However, compliance of the European population to general recommendations of exercise and weight loss is unsatisfactory. There have been no studies that have attempted to convert the exciting new experimental data on the circadian clock, lifestyle, and cardiometabolic risk into diagnostic tools or novel therapeutic approaches via structured multidisciplinary efforts. One of the aims of the EuRhytDia study is to study novel applications of established lifestyle interventions by co-ordinating the timing of interventions with circadian rhythmicity.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Universitätsklinikum Hamburg-Eppendorf.