Light and Exercise in Night-shift Workers

NCT ID: NCT01767181

Last Updated: 2017-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2016-12-31

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.

Conditions

Healthy Night Shift Workers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

A

Control group without intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

B

Intensive light therapy during the first half of the night shift

Group Type: EXPERIMENTAL

Intensive light therapy

Intervention Type: OTHER

Light therapy will be applied by a Lumie Brazil fluorescent tube light box (10.000 lux) during the night shifts for 12 consecutive weeks

C

Exercise before the beginning of the night shift

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

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)

D

Exercise after the end of the night shift

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

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)

Interventions

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

Intervention Type: OTHER

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)

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rainer Böger, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Countries

Germany

Other Identifiers

EuRhythDia-1

Identifier Type: -

Identifier Source: org_study_id