SleepNCT03514953
The Impact of Physical (In)Activity on Sleep Quality
A study testing Reduced Physical Activity in people with Sleep, run by Virginia Commonwealth University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Reduced Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2018to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals with average weekly step count greater than 7500
- Low risk of cardiovascular, pulmonary, and metabolic disease
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
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.
Read the 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.
- Conditions
- Sleep
- Being tested
- Reduced Physical Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced Physical ActivityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Reduced Physical Activity | Experimental | Participants will reduce their physical activity level by >5000 steps per day for two weeks. Receives: Behavioral: Reduced Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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))
Measured: 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))
Measured: Day 21 to Day 28
Secondary outcomes (10)
Level of Tumor Necrosis Factor Alpha in blood
Measurement of inflammation with greater levels indicating more inflammation
Measured: Measured on Day 7, Day 14, Day 21, Day 28
Level of Interleukin-6 in blood
Measurement of inflammation with greater levels indicating more inflammation
Measured: Measured on Day 7, Day 14, Day 21, Day 28
Level of Interleukin-1 in blood
Measurement of inflammation with greater levels indicating more inflammation
Measured: Measured on Day 7, Day 14, Day 21, Day 28
Level of Norepinephrine in blood
Measurement of catecholamine production with greater levels indicating more production
Measured: Measured on Day 7, Day 14, Day 21, Day 28
Level of Epinephrine in blood
Measurement of catecholamine production with greater levels indicating more production
Measured: Measured on Day 7, Day 14, Day 21, Day 28
Level of Lipid peroxidation in blood
Measurement of oxidative stress with greater levels indicating more oxidative stress
Measured: Measured on Day 7, Day 14, Day 21, Day 28
Protein oxidation in blood
Measurement of oxidative stress with greater levels indicating more oxidative stress
Measured: Measured on Day 7, Day 14, Day 21, Day 28
Change in Lower Limb Vascular Function
Measurement of popliteal artery dilation after 5 minutes of lower limb occlusion
Measured: Measured on Day 7, Day 14, Day 21, Day 28
Change in Upper Limb Vascular Function
Measurement of brachial artery dilation after 5 minutes of lower limb occlusion
Measured: Measured on Day 7, Day 14, Day 21, Day 28
Change in Leg Vascular Function
Measurement of leg blood flow during 1 minute of passive leg movement
Measured: Measured on Day 7, Day 14, Day 21, Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2018
- Study start20 Apr 2018
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan Garten, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514953
- Sponsor's protocol ID
- HM20012432
- Status last verified
- Feb 2020
- First submitted
- 20 Apr 2018
- Last updated
- 10 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Physical (In)Activity on Sleep Quality
- ClinicalTrials.gov ID
- NCT03514953
- Acronym / sponsor ID
- HM20012432
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 20 Apr 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 3 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reduced Physical Activity | Experimental | Behavioral: Reduced Physical ActivityParticipants will reduce their physical activity level by >5000 steps per day for two weeks. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy individuals with average weekly step count greater than 7500
- Low risk of cardiovascular, pulmonary, and metabolic disease
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reduced Physical ActivityPreliminary 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. | Behavioural | Reduced Physical Activity |
Primary outcome
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))
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))
10 secondary outcomes
Level of Tumor Necrosis Factor Alpha in blood
Time frame: 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
Level of Interleukin-1 in blood
Time frame: 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
Level of Epinephrine in blood
Time frame: 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
Protein oxidation in blood
Time frame: 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
Change in Upper Limb Vascular Function
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Garten, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduced Physical Activity in people with Sleep, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sleep quality (phase 1) (time frame: Day 7 to Day 21). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2020.