- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03514953
The Impact of Physical (In)Activity on Sleep Quality
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Virginia
-
Richmond, Virginia, Forenede Stater, 23298
- Virginia Commonwealth University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Healthy individuals with average weekly step count greater than 7500
- Low risk of cardiovascular, pulmonary, and metabolic disease
Exclusion Criteria:
- Individuals with cardiovascular, pulmonary, and metabolic disease
- Individuals taking medications that may affect cardiovascular, pulmonary, and metabolic function
- Diet differs substantially from typical diet, significant calorie restriction, or vitamin/mineral deficiencies
- Pregnant women
- Prisoners
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Reduced Physical Activity
Participants will reduce their physical activity level by >5000 steps per day for two weeks.
|
Preliminary Phase (Baseline to Day 7): Subjects will begin wearing an accelerometer for 7 days to track physical activity and sleep patterns. Experimental Phase 1 (Day 7 to Day 21): Participants will be required to reduce their step count by 5,000 steps per day and engage in no moderate-vigorous physical activity during this timeframe. Every 7 days subjects undergo the blood draw, vascular health measures and questionnaire assessments. Experimental Phase 2 (Day 21 to 28): During the week of assessment, subjects will be asked to return to their normal physical activity patterns. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in sleep quality (phase 1)
Tidsramme: Day 7 to Day 21
|
Evaluation of sleep efficiency (the ratio of total sleep time to the total time recorded in which the subject was not asleep (i.e.
brief awakenings))
|
Day 7 to Day 21
|
Change in sleep quality (phase 2)
Tidsramme: Day 21 to Day 28
|
Evaluation of sleep efficiency (the ratio of total sleep time to the total time recorded in which the subject was not asleep (i.e.
brief awakenings))
|
Day 21 to Day 28
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Level of Tumor Necrosis Factor Alpha in blood
Tidsramme: Measured on Day 7, Day 14, Day 21, Day 28
|
Measurement of inflammation with greater levels indicating more inflammation
|
Measured on Day 7, Day 14, Day 21, Day 28
|
Level of Interleukin-6 in blood
Tidsramme: Measured on Day 7, Day 14, Day 21, Day 28
|
Measurement of inflammation with greater levels indicating more inflammation
|
Measured on Day 7, Day 14, Day 21, Day 28
|
Level of Interleukin-1 in blood
Tidsramme: Measured on Day 7, Day 14, Day 21, Day 28
|
Measurement of inflammation with greater levels indicating more inflammation
|
Measured on Day 7, Day 14, Day 21, Day 28
|
Level of Norepinephrine in blood
Tidsramme: Measured on Day 7, Day 14, Day 21, Day 28
|
Measurement of catecholamine production with greater levels indicating more production
|
Measured on Day 7, Day 14, Day 21, Day 28
|
Level of Epinephrine in blood
Tidsramme: Measured on Day 7, Day 14, Day 21, Day 28
|
Measurement of catecholamine production with greater levels indicating more production
|
Measured on Day 7, Day 14, Day 21, Day 28
|
Level of Lipid peroxidation in blood
Tidsramme: Measured on Day 7, Day 14, Day 21, Day 28
|
Measurement of oxidative stress with greater levels indicating more oxidative stress
|
Measured on Day 7, Day 14, Day 21, Day 28
|
Protein oxidation in blood
Tidsramme: Measured on Day 7, Day 14, Day 21, Day 28
|
Measurement of oxidative stress with greater levels indicating more oxidative stress
|
Measured on Day 7, Day 14, Day 21, Day 28
|
Change in Lower Limb Vascular Function
Tidsramme: Measured on Day 7, Day 14, Day 21, Day 28
|
Measurement of popliteal artery dilation after 5 minutes of lower limb occlusion
|
Measured on Day 7, Day 14, Day 21, Day 28
|
Change in Upper Limb Vascular Function
Tidsramme: Measured on Day 7, Day 14, Day 21, Day 28
|
Measurement of brachial artery dilation after 5 minutes of lower limb occlusion
|
Measured on Day 7, Day 14, Day 21, Day 28
|
Change in Leg Vascular Function
Tidsramme: Measured on Day 7, Day 14, Day 21, Day 28
|
Measurement of leg blood flow during 1 minute of passive leg movement
|
Measured on Day 7, Day 14, Day 21, Day 28
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Ryan Garten, PhD, Virginia Commonwealth University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- HM20012432
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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 .
Kliniske forsøg med Søvn
-
University of Wisconsin, MadisonPhilips HealthcareAfsluttetSøvn, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization
-
Aventure ABAktiv, ikke rekrutterende
-
National Taiwan University HospitalUkendt
-
National University of SingaporeRekrutteringReduktion af skærmbrug + Sleep Extension | Frit levendeSingapore
-
The First Affiliated Hospital of Shanxi Medical...Shanxi Medical UniversityAfsluttetSøvnkvalitet | Søvnvarighed | Sleep Onset LatencyKina
-
Northwell HealthJazz PharmaceuticalsRekrutteringElektrisk status Epilepticus af Slow-Wave SleepForenede Stater
-
University of Geneva, SwitzerlandAfsluttetNatlige benkramper | Sleep Wake Transition DisordersSchweiz
-
Tyco Healthcare GroupUkendt
-
Maastricht University Medical CenterEpilepsiecentrum KempenhaegheAfsluttetRolandsk Epilepsi | Landau-Kleffners syndrom | Natlig frontallappens epilepsi | Elektrisk status Epilepticus under Slow Wave SleepHolland
Kliniske forsøg med Reduced Physical Activity
-
Wake Forest University Health SciencesNational Heart, Lung, and Blood Institute (NHLBI)AfsluttetFysisk aktivitetForenede Stater
-
The Miriam HospitalUkendtSlag | Stillesiddende livsstil | Iskæmisk angreb, forbigående | Dyrke motionForenede Stater
-
Centre Hospitalier Universitaire de Saint EtienneNational Cancer Institute, FranceAfsluttetKræft prostataFrankrig
-
IVI BilbaoInstituto Valenciano de Infertilidad, IVI VALENCIAAfsluttet
-
Istanbul Kültür UniversityMarmara University; Istanbul University - Cerrahpasa (IUC)AfsluttetFysisk aktivitet | Parkinsons sygdom | Balance | Falder | KinesiofobiKalkun
-
Istanbul Kültür UniversityTrukket tilbageFysisk aktivitetsniveau | Bevidsthed om fysisk aktivitet
-
Cairo UniversityTilmelding efter invitation
-
Memorial Sloan Kettering Cancer CenterAktiv, ikke rekrutterendeKarcinom | KræftForenede Stater
-
Saglik Bilimleri UniversitesiIkke rekrutterer endnuPes Planus