The Impact of Physical (In)Activity on Sleep Quality

NCT03514953 | Completed

• 1 other identifier: HM20012432
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (10)

• Level of Tumor Necrosis Factor Alpha in blood

  Measured on Day 7, Day 14, Day 21, Day 28

• Level of Interleukin-6 in blood

  Measured on Day 7, Day 14, Day 21, Day 28

• Level of Interleukin-1 in blood

  Measured on Day 7, Day 14, Day 21, Day 28

• Level of Norepinephrine in blood

  Measured on Day 7, Day 14, Day 21, Day 28

• Level of Epinephrine in blood

  Measured on Day 7, Day 14, Day 21, Day 28

Study Arms (1)

Reduced Physical Activity

EXPERIMENTAL

Participants will reduce their physical activity level by \>5000 steps per day for two weeks.

Behavioral: Reduced Physical Activity

Interventions

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.

Reduced Physical Activity

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy individuals with average weekly step count greater than 7500
• Low risk of cardiovascular, pulmonary, and metabolic disease

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Study Officials

• Ryan Garten, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2018
• First Posted: May 3, 2018
• Study Start: April 20, 2018
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: February 10, 2020

Record last verified: 2020-02

Locations

US (1)