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The Impact of Physical (In)Activity on Sleep Quality

7. februar 2020 opdateret af: Virginia Commonwealth University
The proposed research will examine the role of physical activity (PA) on altering sleep quality (SQ) while systematically examining novel mechanisms that may drive changes in SQ. Specifically, the study will examine how a 2 week reduction in PA alters sleep quality in young, healthy individuals. Additionally, during this reduction in PA, the study will examine changes in inflammation, oxidative stress, and sympathetic activity to identify potential mechanisms for alterations in sleep quality.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Sleep, which makes up approximately one third of an individual's life, plays a vital role in normal bodily functioning by regulating metabolic and endocrine function. Disturbed sleep, defined as any alteration to normal sleep patterns, is highly prevalent, affecting 35% and 41% of the general population in the United States and has been linked to poor cardiovascular health, diabetes, obesity, dyslipidemia, and hypertension. Young adults are a population at high risk for disturbed sleep-related health outcomes due to negative lifestyle behaviors such as alcohol consumption, drug use, study patterns, and excessive screen time that remain with advancing age. Due to the importance of improving or maintaining health outcomes through adequate sleep quality (SQ), the proposed research will examine the role of physical activity (PA) on altering SQ while systematically examining novel mechanisms that may drive changes in SQ. Specifically, this study will examine how alterations (increases and decreases) in PA impact SQ and how these alterations modify inflammation, oxidative stress, and sympathetic stimulation in young adults.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

33

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Virginia
      • Richmond, Virginia, Forenede Stater, 23298
        • Virginia Commonwealth University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 35 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Ryan Garten, PhD, Virginia Commonwealth University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. april 2018

Primær færdiggørelse (Faktiske)

30. september 2019

Studieafslutning (Faktiske)

30. september 2019

Datoer for studieregistrering

Først indsendt

20. april 2018

Først indsendt, der opfyldte QC-kriterier

20. april 2018

Først opslået (Faktiske)

3. maj 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. februar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. februar 2020

Sidst verificeret

1. februar 2020

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • HM20012432

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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

Kliniske forsøg med Reduced Physical Activity

3
Abonner