Clinical trial NCT01767181: Light and Exercise in Night-shift Workers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Night Shift Workers
Keywords: Light therapy
physical exercise
night shift workers
genetic markers
PBMCs
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2013-01-14
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy
timeFrame: 12 weeks
Secondary outcomes:
measure: Efficacy
timeFrame: 12 weeks
measure: Efficacy
timeFrame: 12 weeks
measure: Efficacy
timeFrame: 12 weeks
measure: Efficacy
timeFrame: 12 weeks
measure: Efficacy
timeFrame: 12 weeks
measure: Efficacy
timeFrame: 12 weeks
measure: Efficacy
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Rainer Böger, MD
role: PRINCIPAL_INVESTIGATOR
References: