NCT06638359

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2024

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

1 year

First QC Date

September 18, 2024

Last Update Submit

October 9, 2024

Conditions

Exercise AddictionControl Condition

Keywords

Heart rate variabilitysleep quality

Outcome Measures

Primary Outcomes (1)

  • total sleep time

    total sleep time on Day 1

    Day 1

Study Arms (2)

exercise

EXPERIMENTAL

moderate intensity or interval exercise

Behavioral: moderate exerciseBehavioral: interval exerciseBehavioral: Control (placebo) group

control

SHAM COMPARATOR

without exercise

Behavioral: moderate exerciseBehavioral: interval exerciseBehavioral: Control (placebo) group

Interventions

moderate exerciseBEHAVIORAL

moderate exercise for 47 minutes

controlexercise
interval exerciseBEHAVIORAL

interval exercise for 28 minutes

controlexercise
Control (placebo) groupBEHAVIORAL

without exercise

controlexercise

Eligibility Criteria

Age20 Years - 64 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University of Sport

Taichung, North, 404, Taiwan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Officials

  • Sport research center

    National Taiwan University of Sport

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
control trial
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 18, 2024

First Posted

October 15, 2024

Study Start

December 10, 2022

Primary Completion

December 10, 2023

Study Completion

August 31, 2024

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

No plan to share IPD

Locations

TW(1)