- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06848322
The Effects of 8-week Resistance and Aerobic Exercise on Anxiety, Depression, Sleep, Inhibitory Control in Young Adults With Smartphone Overdependence
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Seoul
-
Dongdaemun, Seoul, Korea, Republic of
- University of Seoul, Centennial Memorial Hall.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Smartphone overdependent scale score of 24 ≥
- No regular exercise in the past 3 months
Exclusion Criteria:
- Unable to perform exercise
- Patients with musculoskeletal disorders
- Patients with cardiovascular diseases.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: resistance exercise group
They will perform resistance exercise for 8 weeks.
|
Participants will perform resistance exercise for 8 weeks
Other Names:
|
|
Experimental: aerobic exercise group
They will perform aerobic exercise for 8 weeks.
|
Participants will perform aerobic exercise for 8 weeks
|
|
Sham Comparator: control group
They will maintain their usual lifestyle for 8 weeks.
|
Participants will maintain their usual lifestyle for 8 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
sleep duration
Time Frame: pre intervention: for 8days(before the intervention) / post intervention: for 8days(after the intervention)
|
In this study, we will assess participants' sleep duration using a wrist-worn GENEActiv triaxial accelerometer (Activinsights, Cambridge, UK).
Participants will be instructed to wear the device on their non-dominant wrist 24 hours a day for 8 days, except during contact sports that may pose a risk of injury.
Sleep duration (minutes) is defined as the total time spent sleeping.
|
pre intervention: for 8days(before the intervention) / post intervention: for 8days(after the intervention)
|
|
Sleep efficiency
Time Frame: pre intervention: for 8days(before the intervention) / post intervention: for 8days(after the intervention)
|
In this study, we will assess participants' sleep efficiency using a wrist-worn GENEActiv triaxial accelerometer (Activinsights, Cambridge, UK).
Participants will be instructed to wear the device on their non-dominant wrist 24 hours a day for 8 days, except during contact sports that may pose a risk of injury.
Sleep efficiency(%) is defined as the proportion of time spent asleep relative to time in bed
|
pre intervention: for 8days(before the intervention) / post intervention: for 8days(after the intervention)
|
|
Time in bed
Time Frame: pre intervention: for 8days(before the intervention) / post intervention: for 8days(after the intervention)
|
In this study, we will assess participants' time in bed using a wrist-worn GENEActiv triaxial accelerometer (Activinsights, Cambridge, UK).
Participants will be instructed to wear the device on their non-dominant wrist 24 hours a day for 8 days, except during contact sports that may pose a risk of injury.
Time in bed (minutes) is defined as the total time spent in bed, including both sleep and wakefulness
|
pre intervention: for 8days(before the intervention) / post intervention: for 8days(after the intervention)
|
|
Sleep onset time
Time Frame: pre intervention: for 8days(before the intervention) / post intervention: for 8days(after the intervention)
|
In this study, we will assess participants' sleep onset time using a wrist-worn GENEActiv triaxial accelerometer (Activinsights, Cambridge, UK).
Participants will be instructed to wear the device on their non-dominant wrist 24 hours a day for 8 days, except during contact sports that may pose a risk of injury.
Sleep onset time (hours and minutes) is defined as the time at which sleep begins.
|
pre intervention: for 8days(before the intervention) / post intervention: for 8days(after the intervention)
|
|
wake time
Time Frame: pre intervention: for 8days(before the intervention) / post intervention: for 8days(after the intervention)
|
In this study, we will assess participants' sleep onset time using a wrist-worn GENEActiv triaxial accelerometer (Activinsights, Cambridge, UK).
Participants will be instructed to wear the device on their non-dominant wrist 24 hours a day for 8 days, except during contact sports that may pose a risk of injury.
Wake time (hours and minutes) is defined as the final wake-up time.
|
pre intervention: for 8days(before the intervention) / post intervention: for 8days(after the intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression
Time Frame: pre intervention(day 1), post intervention(day 57)
|
Participants will visit the laboratory to complete the Beck Depression Inventory(BDI), a self-reported questionnaire assessing depressive symptoms.
The BDI consists of 21 items, each scored on a scale from 0 to 3, with total scores ranging from 0 to 63.
Higher scores indicate more severe depressive symptoms
|
pre intervention(day 1), post intervention(day 57)
|
|
Anxiety
Time Frame: pre intervention(day 1), post intervention(day 57)
|
Participants will visit the laboratory to complete the Beck Anxiety Inventory (BAI), a self-reported questionnaire assessing anxiety symptoms.
The BAI consists of 21 items, each scored on a scale from 0 to 3, with total scores ranging from 0 to 63.
Higher scores indicate more severe anxiety symptoms.
|
pre intervention(day 1), post intervention(day 57)
|
|
Inhibition
Time Frame: pre intervention(day 1), post intervention(day 57)
|
The Go/NoGo task will be used to measure the inhibition The measured variables will include reaction time (RT) and accuracy. At the beginning of the test, a series of stimulus characters will be presented in the center of the screen one by one. Each stimulus character will be displayed for 400 ms, with a random interval of 400-700 ms between stimuli. Before the test, participants will be informed that "L" is a Go stimulus and "C" is a NoGo stimulus. When "L" appears in the center of the screen, participants will be required to press the space bar key with their index finger as quickly and accurately as possible. When "C" appears, participants must not respond. The system will record the reaction time and accuracy for Go stimuli and the accuracy for NoGo stimuli. The total number of stimulus characters will be 240, consisting of 180 Go stimuli (75%) and 60 NoGo stimuli (25%). |
pre intervention(day 1), post intervention(day 57)
|
Collaborators and Investigators
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- UOS 2024-08-007-004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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