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The Impact of Physical (In)Activity on Sleep Quality

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ClinicalTrials.gov Identifier: NCT03514953
Recruitment Status : Recruiting
First Posted : May 3, 2018
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Tracking Information
First Submitted Date  ICMJE April 20, 2018
First Posted Date  ICMJE May 3, 2018
Last Update Posted Date October 9, 2019
Actual Study Start Date  ICMJE April 20, 2018
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2018)
  • Change in sleep quality (phase 1) [ Time Frame: 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))
  • Change in sleep quality (phase 2) [ Time Frame: 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))
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03514953 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2018)
  • Level of Tumor Necrosis Factor Alpha in blood [ Time Frame: Measured on Day 7, Day 14, Day 21, Day 28 ]
    Measurement of inflammation with greater levels indicating more inflammation
  • Level of Interleukin-6 in blood [ Time Frame: Measured on Day 7, Day 14, Day 21, Day 28 ]
    Measurement of inflammation with greater levels indicating more inflammation
  • Level of Interleukin-1 in blood [ Time Frame: Measured on Day 7, Day 14, Day 21, Day 28 ]
    Measurement of inflammation with greater levels indicating more inflammation
  • Level of Norepinephrine in blood [ Time Frame: Measured on Day 7, Day 14, Day 21, Day 28 ]
    Measurement of catecholamine production with greater levels indicating more production
  • Level of Epinephrine in blood [ Time Frame: Measured on Day 7, Day 14, Day 21, Day 28 ]
    Measurement of catecholamine production with greater levels indicating more production
  • Level of Lipid peroxidation in blood [ Time Frame: Measured on Day 7, Day 14, Day 21, Day 28 ]
    Measurement of oxidative stress with greater levels indicating more oxidative stress
  • Protein oxidation in blood [ Time Frame: Measured on Day 7, Day 14, Day 21, Day 28 ]
    Measurement of oxidative stress with greater levels indicating more oxidative stress
  • Change in Lower Limb Vascular Function [ Time Frame: Measured on Day 7, Day 14, Day 21, Day 28 ]
    Measurement of popliteal artery dilation after 5 minutes of lower limb occlusion
  • Change in Upper Limb Vascular Function [ Time Frame: Measured on Day 7, Day 14, Day 21, Day 28 ]
    Measurement of brachial artery dilation after 5 minutes of lower limb occlusion
  • Change in Leg Vascular Function [ Time Frame: Measured on Day 7, Day 14, Day 21, Day 28 ]
    Measurement of leg blood flow during 1 minute of passive leg movement
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Impact of Physical (In)Activity on Sleep Quality
Official Title  ICMJE The Impact of Physical (In)Activity on Sleep Quality
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Sleep
Intervention  ICMJE Behavioral: Reduced Physical Activity

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.

Study Arms  ICMJE Experimental: Reduced Physical Activity
Participants will reduce their physical activity level by >5000 steps per day for two weeks.
Intervention: Behavioral: Reduced Physical Activity
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 20, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Ryan Garten, PhD (804) 828-1948 rsgarten@vcu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03514953
Other Study ID Numbers  ICMJE HM20012432
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Virginia Commonwealth University
Study Sponsor  ICMJE Virginia Commonwealth University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ryan Garten, PhD Virginia Commonwealth University
PRS Account Virginia Commonwealth University
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP