The Impact of Physical (In)Activity on Sleep Quality

February 7, 2020 updated by: 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.

Study Overview

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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))
Day 7 to Day 21
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))
Day 21 to Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measured on Day 7, Day 14, Day 21, Day 28
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
Measured on Day 7, Day 14, Day 21, Day 28
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
Measured on Day 7, Day 14, Day 21, Day 28
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
Measured on Day 7, Day 14, Day 21, Day 28
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
Measured on Day 7, Day 14, Day 21, Day 28
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
Measured on Day 7, Day 14, Day 21, Day 28
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
Measured on Day 7, Day 14, Day 21, Day 28
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
Measured on Day 7, Day 14, Day 21, Day 28
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
Measured on Day 7, Day 14, Day 21, Day 28
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
Measured on Day 7, Day 14, Day 21, Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ryan Garten, PhD, Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2018

Primary Completion (Actual)

September 30, 2019

Study Completion (Actual)

September 30, 2019

Study Registration Dates

First Submitted

April 20, 2018

First Submitted That Met QC Criteria

April 20, 2018

First Posted (Actual)

May 3, 2018

Study Record Updates

Last Update Posted (Actual)

February 10, 2020

Last Update Submitted That Met QC Criteria

February 7, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • HM20012432

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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