An interventional study of Reduced Physical Activity in Sleep, sponsored by Virginia Commonwealth University. Completed at 1 site in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-10.
Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Basic science
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.
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.
Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.
Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Change in sleep quality (phase 1)
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))
Time frame: Day 7 to Day 21
Change in sleep quality (phase 2)
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))
Time frame: Day 21 to Day 28
Level of Tumor Necrosis Factor Alpha in blood
Measurement of inflammation with greater levels indicating more inflammation
Time frame: Measured on Day 7, Day 14, Day 21, Day 28
Level of Interleukin-6 in blood
Measurement of inflammation with greater levels indicating more inflammation
Time frame: Measured on Day 7, Day 14, Day 21, Day 28
Level of Interleukin-1 in blood
Measurement of inflammation with greater levels indicating more inflammation
Time frame: Measured on Day 7, Day 14, Day 21, Day 28
Level of Norepinephrine in blood
Measurement of catecholamine production with greater levels indicating more production
Time frame: Measured on Day 7, Day 14, Day 21, Day 28
Level of Epinephrine in blood
Measurement of catecholamine production with greater levels indicating more production
Time frame: Measured on Day 7, Day 14, Day 21, Day 28
Level of Lipid peroxidation in blood
Measurement of oxidative stress with greater levels indicating more oxidative stress
Time frame: Measured on Day 7, Day 14, Day 21, Day 28
Protein oxidation in blood
Measurement of oxidative stress with greater levels indicating more oxidative stress
Time frame: Measured on Day 7, Day 14, Day 21, Day 28
Change in Lower Limb Vascular Function
Measurement of popliteal artery dilation after 5 minutes of lower limb occlusion
Time frame: Measured on Day 7, Day 14, Day 21, Day 28
Change in Upper Limb Vascular Function
Measurement of brachial artery dilation after 5 minutes of lower limb occlusion
Time frame: Measured on Day 7, Day 14, Day 21, Day 28
Change in Leg Vascular Function
Measurement of leg blood flow during 1 minute of passive leg movement
Time frame: Measured on Day 7, Day 14, Day 21, Day 28
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Virginia Commonwealth University