- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02636335
Light, Exercise Intensity and Mood in Overweight (LEXI-MO)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Basel, Schweiz, 4052
- Departement of Sport, Exercise and Health
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
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Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Mean power output in watts
Tidsramme: Power output during the first 30 minute time-trial on a bicycle ergometer.
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Power output during the first 30 minute time-trial on a bicycle ergometer.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Subjective sleepiness
Tidsramme: 1 minute after the light exposure vs. 1 minute before the light exposure in the first time trial
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Subjective sleepiness will be measured with the Multidimensional Mood Questionnaire (Category "Wakefulness - Sleepiness")
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1 minute after the light exposure vs. 1 minute before the light exposure in the first time trial
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Subjective Mood
Tidsramme: 1 minute after the light exposure vs. 1 minute before the light exposure in the first time trial
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Subjective Mood measured with the Multidimensional Mood Questionnaire (Category "Good Mood - Bad Mood")
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1 minute after the light exposure vs. 1 minute before the light exposure in the first time trial
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Mean power output in watts during the first, second and third time-trial on a bicycle ergometer.
Tidsramme: Mean of the 30 minutes of the exercise from the first, second and third time-trial.
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Mean of the 30 minutes of the exercise from the first, second and third time-trial.
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Arno Schmidt-Trucksäss, Prof., University of Basel
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- LEXI-MO
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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