Exercise AddictionEX&sleepNCT06638359
Effects of Moderate Exercise And Interval Exercise On Sleep Quality
A study testing moderate exercise and interval exercise in people with Exercise Addiction and Control Condition, run by National Taiwan Sport University at 1 site in Taiwan.
Trial summary
This study aimed to explore the effects of a single bout of moderate- aerobic continuous exercise (MACE) and high-intensity intermittent exercise (HIIE) on sleep during continuous night shifts in medical shift workers with mild sleep impairment. Read more about this study
- Who is it for?
- Ages 20 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise Addiction, Control Condition
- What is being tested?
- moderate exercise and interval exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Dec 2022to 31 Aug 2024
- 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 20 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- medical staff who have worked at least three consecutive night shifts
- reporting sleep disturbed during the night shift
- not taking sleep/psychotropic medications
- no clinical diagnosis of sleep apnea or other sleep disorder
- not exercising regularly
Who cannot join
- not medical staff
- without night shift
- taking sleep/psychotropic medications
- exercising regularly
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of an Acute Bout of Moderate-Intensity Aerobic Exercise And High-Intensity Intermittent Exercise On Sleep During Night Shifts In Medical Shift Workers With Sleep Impairment: A Single-Blind Crossover Randomized Controlled Trial
This study aimed to explore the effects of a single bout of moderate- aerobic continuous exercise (MACE) and high-intensity intermittent exercise (HIIE) on sleep during continuous night shifts in medical shift workers with mild sleep impairment.
Read the detailed description
Medical staff with sleep disturbances due to their night-shift work were randomized to either a treadmill walking session for 47 minutes with moderate intensity (the heart rate reaches 70~75% of the maximum heart rate), treadmill running section for 28 minutes with intermittent high-intensity (the heart rate reaches 90~95% of the maximum heart rate for 4 minutes and 50~70% for 3 minutes), or a quiet-rest control, 14 hours before undertaking a continuous night shift. Sleep quality was assessed by ActiGraph with subjective questionnaire for 1 night and 3 nights after exercise. Tests were performed (t-tests or χ2 tests) to test for differences between any two of the three intervention trials.
- Conditions
- Exercise Addiction, Control Condition
- Being tested
- moderate exercise, interval exercise, Control (placebo) group
- Keywords
- Heart rate variability, sleep quality
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
moderate exerciseBehavioural
moderate exercise for 47 minutes
interval exerciseBehavioural
interval exercise for 28 minutes
Control (placebo) groupBehavioural
without exercise
| Study group | Role | What they receive |
|---|---|---|
| exercise | Experimental | moderate intensity or interval exercise Receives: Behavioral: moderate exercise; Behavioral: interval exercise; Behavioral: Control (placebo) group |
| control | Sham comparator | without exercise Receives: Behavioral: moderate exercise; Behavioral: interval exercise; Behavioral: Control (placebo) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
total sleep time
total sleep time on Day 1
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start10 Dec 2022
- Primary completion10 Dec 2023
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise AddictionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The effects of a single bout of moderate- aerobic continuous exercise (MACE) and high-intensity intermittent exercise (HIIE) on sleep during continuous night shifts in medical shift workers with mild sleep impairment.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan Sport University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chih-Hui Chiu, National Taiwan Sport University
- Investigators
- Sport research center, Principal investigator, National Taiwan University of Sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638359
- Sponsor's protocol ID
- 113-6
- Other IDs
- 113-3
- Acronym
- EX&sleep
- Status last verified
- Oct 2024
- First submitted
- 18 Sep 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Acute Bout of Moderate-Intensity Aerobic Exercise And High-Intensity Intermittent Exercise On Sleep During Night Shifts In Medical Shift Workers With Sleep Impairment: A Single-Blind Crossover Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06638359
- Acronym / sponsor ID
- EX&sleep / 113-6
- Conditions
- Exercise Addiction, Control Condition
- Keywords
- Heart rate variability, sleep quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- National Taiwan Sport UniversityUniversity, hospital or other
- Study start
- 10 Dec 2022 (actual)
- Primary completion
- 10 Dec 2023 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 15 Oct 2024 (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.
This study aimed to explore the effects of a single bout of moderate- aerobic continuous exercise (MACE) and high-intensity intermittent exercise (HIIE) on sleep during continuous night shifts in medical shift workers with mild sleep impairment.
Detailed description
Medical staff with sleep disturbances due to their night-shift work were randomized to either a treadmill walking session for 47 minutes with moderate intensity (the heart rate reaches 70~75% of the maximum heart rate), treadmill running section for 28 minutes with intermittent high-intensity (the heart rate reaches 90~95% of the maximum heart rate for 4 minutes and 50~70% for 3 minutes), or a quiet-rest control, 14 hours before undertaking a continuous night shift. Sleep quality was assessed by ActiGraph with subjective questionnaire for 1 night and 3 nights after exercise. Tests were performed (t-tests or χ2 tests) to test for differences between any two of the three intervention trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The effects of a single bout of moderate- aerobic continuous exercise (MACE) and high-intensity intermittent exercise (HIIE) on sleep during continuous night shifts in medical shift workers with mild sleep impairment.
| Arm | Type | Receives |
|---|---|---|
| exercise | Experimental | Behavioral: moderate exercise, Behavioral: interval exercise, Behavioral: Control (placebo) groupmoderate intensity or interval exercise |
| control | Sham comparator | Behavioral: moderate exercise, Behavioral: interval exercise, Behavioral: Control (placebo) groupwithout exercise |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- medical staff who have worked at least three consecutive night shifts
- reporting sleep disturbed during the night shift
- not taking sleep/psychotropic medications
- no clinical diagnosis of sleep apnea or other sleep disorder
- not exercising regularly
Key exclusion criteria (4 listed)
- not medical staff
- without night shift
- taking sleep/psychotropic medications
- exercising regularly
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 |
|---|---|---|
| moderate exercisemoderate exercise for 47 minutes | Behavioural | control, exercise |
| interval exerciseinterval exercise for 28 minutes | Behavioural | control, exercise |
| Control (placebo) groupwithout exercise | Behavioural | control, exercise |
Primary outcome
total sleep time
Time frame: Day 1
total sleep time on Day 1
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 15 Oct 2024.
- Individual participant dataSharing planned: No. No plan to share IPD
Related trials for Exercise Addiction
Recruiting
Development and Investigation of the ApneaTheraPlay
Apnea, Obstructive, Exercise Addiction
Recruiting
Group-based IMPROVE Therapy for Problematic Internet Use in University Students
Problematic Internet Use
Not yet recruiting
Virtual Reality Exercise for Young Adults at Risk of Digital Gaming Addiction
Internet Gaming Disorder
RecruitingObservational study
Smartphone Addiction, Posture and Breathing Control in University Students
Smartphone Addiction, Postural Disorders
RecruitingObservational study
Systematic Examination of Health Inequalities: Documentation, Patterns, and Determinants
Non-communicable Diseases (NCD), Addiction to Opioids
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.
Sport research center principal investigator
National Taiwan University of Sport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing moderate exercise and interval exercise in people with Exercise Addiction and Control Condition, run by National Taiwan Sport University at 1 site in Taiwan.
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 5 inclusion and 4 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 15 Oct 2024. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
total sleep time (time frame: Day 1). 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 15 Oct 2024.