- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03514953
The Impact of Physical (In)Activity on Sleep Quality
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Virginia
-
Richmond, Virginia, United States, 23298
- Virginia Commonwealth University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Principal Investigator: Ryan Garten, PhD, Virginia Commonwealth University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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