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Light, Exercise Intensity and Mood in Overweight (LEXI-MO)

Primary Purpose

Overweight, Obesity Grade I

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Phillips Energy Light HF3319
Sponsored by
University of Basel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight, Obesity Grade I

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Departement of Sport, Exercise and Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Bright Light

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Mean power output in watts

Secondary Outcome Measures

Subjective sleepiness
Subjective sleepiness will be measured with the Multidimensional Mood Questionnaire (Category "Wakefulness - Sleepiness")
Subjective Mood
Subjective Mood measured with the Multidimensional Mood Questionnaire (Category "Good Mood - Bad Mood")
Mean power output in watts during the first, second and third time-trial on a bicycle ergometer.

Full Information

First Posted
December 14, 2015
Last Updated
June 28, 2017
Sponsor
University of Basel
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1. Study Identification

Unique Protocol Identification Number
NCT02636335
Brief Title
Light, Exercise Intensity and Mood in Overweight
Acronym
LEXI-MO
Official Title
Light, Exercise Intensity and Mood in Overweight
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Basel

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine if an exposure to light in the morning has a positive influence on self-chosen exercise intensity on a bicycle ergometer in overweight and obese patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity Grade I

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bright Light
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Phillips Energy Light HF3319
Intervention Description
Exposure to Light administered with Phillips Energy Light HF3319.
Primary Outcome Measure Information:
Title
Mean power output in watts
Time Frame
Power output during the first 30 minute time-trial on a bicycle ergometer.
Secondary Outcome Measure Information:
Title
Subjective sleepiness
Description
Subjective sleepiness will be measured with the Multidimensional Mood Questionnaire (Category "Wakefulness - Sleepiness")
Time Frame
1 minute after the light exposure vs. 1 minute before the light exposure in the first time trial
Title
Subjective Mood
Description
Subjective Mood measured with the Multidimensional Mood Questionnaire (Category "Good Mood - Bad Mood")
Time Frame
1 minute after the light exposure vs. 1 minute before the light exposure in the first time trial
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arno Schmidt-Trucksäss, Prof.
Organizational Affiliation
University of Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departement of Sport, Exercise and Health
City
Basel
ZIP/Postal Code
4052
Country
Switzerland

12. IPD Sharing Statement

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Light, Exercise Intensity and Mood in Overweight

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