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Completed

NCT Number: NCT03514953

The Impact of Physical (In)Activity on Sleep Quality

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.

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reduced Physical Activity

Behavioral

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 3, 2018
Registry last updated
Feb 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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