The Impact of Physical (In)Activity on Sleep Quality

Sleep Clinical Trial

Official title:

The Impact of Physical (In)Activity on Sleep Quality

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03514953
• Other study ID #: HM20012432
• Status: Completed
• Phase: N/A
• Start date: April 20, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: February 2020
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep

Intervention

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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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))	Day 7 to Day 21
Primary	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))	Day 21 to Day 28
Secondary	Level of Tumor Necrosis Factor Alpha in blood	Measurement of inflammation with greater levels indicating more inflammation	Measured on Day 7, Day 14, Day 21, Day 28
Secondary	Level of Interleukin-6 in blood	Measurement of inflammation with greater levels indicating more inflammation	Measured on Day 7, Day 14, Day 21, Day 28
Secondary	Level of Interleukin-1 in blood	Measurement of inflammation with greater levels indicating more inflammation	Measured on Day 7, Day 14, Day 21, Day 28
Secondary	Level of Norepinephrine in blood	Measurement of catecholamine production with greater levels indicating more production	Measured on Day 7, Day 14, Day 21, Day 28
Secondary	Level of Epinephrine in blood	Measurement of catecholamine production with greater levels indicating more production	Measured on Day 7, Day 14, Day 21, Day 28
Secondary	Level of Lipid peroxidation in blood	Measurement of oxidative stress with greater levels indicating more oxidative stress	Measured on Day 7, Day 14, Day 21, Day 28
Secondary	Protein oxidation in blood	Measurement of oxidative stress with greater levels indicating more oxidative stress	Measured on Day 7, Day 14, Day 21, Day 28
Secondary	Change in Lower Limb Vascular Function	Measurement of popliteal artery dilation after 5 minutes of lower limb occlusion	Measured on Day 7, Day 14, Day 21, Day 28
Secondary	Change in Upper Limb Vascular Function	Measurement of brachial artery dilation after 5 minutes of lower limb occlusion	Measured on Day 7, Day 14, Day 21, Day 28
Secondary	Change in Leg Vascular Function	Measurement of leg blood flow during 1 minute of passive leg movement	Measured on Day 7, Day 14, Day 21, Day 28