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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

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.

Condition or disease Intervention/treatment Phase
Sleep Behavioral: Reduced Physical Activity Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Impact of Physical (In)Activity on Sleep Quality
Actual Study Start Date : April 20, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Experimental: Reduced Physical Activity
Participants will reduce their physical activity level by >5000 steps per day for two weeks.
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.





Primary Outcome Measures :
  1. 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))

  2. 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))


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514953


Contacts
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Contact: Ryan Garten, PhD (804) 828-1948 rsgarten@vcu.edu

Locations
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United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Alanda Perry Jones, MA         
Principal Investigator: Ryan Garten, PhD         
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Ryan Garten, PhD Virginia Commonwealth University

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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03514953     History of Changes
Other Study ID Numbers: HM20012432
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No