- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02636335
Light, Exercise Intensity and Mood in Overweight (LEXI-MO)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Basel, Switzerland, 4052
- Departement of Sport, Exercise and Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Body Mass Index 25 - 35 kg/m2
Exclusion Criteria:
- Women who are pregnant or breast feeding,
- Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- Previous enrolment into the current study
- Participation in other studies in the last four weeks
- Systolic blood pressure > 170 mmHg, diastolic blood pressure > 100 mmHg
- Shift work in the last two months
- Travels across time zones in the last four weeks
- Use of photosensitisation drugs
- Clinical manifest depression
- Cardiovascular diseases which reduce age-appropriate exercise capacity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bright Light
8 a.m. study participants will be exposed to Bright Light (4500 lx) Phillips Energy Light HF3319 for 30 minutes prior and during a 30 minute lasting exercise test with self-chosen exercise intensity on a bicycle ergometer. The light exposure and time-trial will be performed in three repetitive exercise sessions 48h apart. |
Exposure to Light administered with Phillips Energy Light HF3319.
|
Experimental: Control
8 a.m. study participants will be exposed to a Control Light Condition (230 lx) Phillips Energy Light HF3319 for 30 minutes prior and during a 30 minute lasting exercise test with self-chosen exercise intensity on a bicycle ergometer. The light exposure and time-trial will be performed in three repetitive exercise sessions 48h apart. |
Exposure to Light administered with Phillips Energy Light HF3319.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean power output in watts
Time Frame: Power output during the first 30 minute time-trial on a bicycle ergometer.
|
Power output during the first 30 minute time-trial on a bicycle ergometer.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective sleepiness
Time Frame: 1 minute after the light exposure vs. 1 minute before the light exposure in the first time trial
|
Subjective sleepiness will be measured with the Multidimensional Mood Questionnaire (Category "Wakefulness - Sleepiness")
|
1 minute after the light exposure vs. 1 minute before the light exposure in the first time trial
|
Subjective Mood
Time Frame: 1 minute after the light exposure vs. 1 minute before the light exposure in the first time trial
|
Subjective Mood measured with the Multidimensional Mood Questionnaire (Category "Good Mood - Bad Mood")
|
1 minute after the light exposure vs. 1 minute before the light exposure in the first time trial
|
Mean power output in watts during the first, second and third time-trial on a bicycle ergometer.
Time Frame: Mean of the 30 minutes of the exercise from the first, second and third time-trial.
|
Mean of the 30 minutes of the exercise from the first, second and third time-trial.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Arno Schmidt-Trucksäss, Prof., University of Basel
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LEXI-MO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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