Effects of Moderate Exercise And Interval Exercise On Sle... | NCT06638359

Studies
Effects of Moderate Exercise And Interval Exercise On Sleep Quality

NCT06638359

Sponsor

National Taiwan Sport University

Status

Completed

Last Update Posted

Oct 15, 2024Actual

Enrollment

19Actual

Phase

Not Applicable

Conditions

Exercise Addiction
Control Condition

Interventions

moderate exercise
interval exercise
Control (placebo) group

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
113-3	Other Identifier	NTUS

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 10, 2022Actual

Primary Completion Date

Dec 10, 2023Actual

Completion Date

Aug 31, 2024Actual

First Submitted Date

Sep 18, 2024

First Submission Date that Met QC Criteria

Oct 9, 2024

First Posted Date

Oct 15, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 9, 2024

Last Update Posted Date

Oct 15, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
exercise	Experimental	moderate intensity or interval exercise	Behavioral: moderate exercise Behavioral: interval exercise Behavioral: Control (placebo) group
control	Sham Comparator	without exercise	Behavioral: moderate exercise Behavioral: interval exercise Behavioral: Control (placebo) group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
moderate exercise	Behavioral	moderate exercise for 47 minutes	control exercise

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
total sleep time	total sleep time on Day 1	Day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

not medical staff
without night shift
taking sleep/psychotropic medications
exercising regularly

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sport research center	National Taiwan University of Sport	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University of Sport		Taichung	North	404	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

No plan to share IPD

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 1, 2024	Oct 2, 2024	Prot_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D007319	Sleep Initiation and Maintenance Disorders

Ancestor Terms

ID	Term
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D044382	Population Groups

Ancestor Terms

ID	Term
D003710	Demography
D011154	Population Characteristics

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention 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.