NCT03759509

Brief Summary

Shift work in nursing has been found to result in sleep disruption and sleep deprivation, and in sleepiness or fatigue at work. Slow reaction, insufficient attention and poor judgement often come with increased fatigue, which contributes to a high risk of accident and patient safety. Studies have shown that aerobic exercise is helpful in promoting high sleep quality. The study is conducted a prospective parallel randomized trial is performed to 60 nurses with low sleep quality. The subjects are randomly assigned to: (i) the experimental group, in which aerobic exercise training is given; (ii) the control group, in which the subjects kept their original lifestyles. The study aims to investigate the effects of aerobic exercise training on nurses' sleep quality, fatigue, attention and cortisol profile.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

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

November 1, 2018

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 30, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

October 9, 2020

Status Verified

November 1, 2018

Enrollment Period

10 months

First QC Date

November 27, 2018

Last Update Submit

October 7, 2020

Conditions

Outcome Measures

Primary Outcomes (4)

  • Total sleep time sleep change

    The actigraphy reported on sleep parameters of the amount of actual sleep minutes

    The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week

  • Wake after sleep onset change

    The actigraphy reported on the amount of minutes they were awake between sleep onset and wake time.

    The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week

  • Sleep efficiency change

    The actigraphy reported on sleep parameters of percentage of time asleep while in bed from lights off to lights on.

    The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week

  • Seep onset latency change

    The actigraphy reported on sleep parameters of the minutes between lights off and first sleep episode.

    The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week

Secondary Outcomes (2)

  • Simple visual reaction time testing

    Before and after work, the test are completed within 5 min

  • Saliva cortisol

    Collected at awakening [0 min] and at 30 min, 6 hours, and 12 hours after awakening

Study Arms (2)

aerobic exercise training

EXPERIMENTAL

three times a week, a total of twenty-four times in eight weeks

Behavioral: aerobic exercise

control

NO INTERVENTION

routine activity

Interventions

the experimental group, in which aerobic exercise training is given three times a week, a total of twenty-four times in eight weeks

aerobic exercise training

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Full-time
  • Female nursing staff members
  • Worked 8 hours per shift
  • Had at least 1 year of work experience.

You may not qualify if:

  • Had used sedatives, hypnotics, antihistamines, or hormonal drugs within the 4 weeks before commencing the study
  • Pregnant
  • Were diagnosed as having sleep or stress disorders, or experienced sleep problems owing to concurrent insomnia or sleep apnea.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University

Taipei, 110, Taiwan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersFatigue

Interventions

Exercise

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • shu fen Niu, PhD

    Taipei Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The study will randomly sample from previously screen low sleep quality participants, then random assign to experimental (aerobic exercise) and control (routine activity) groups
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2018

First Posted

November 30, 2018

Study Start

November 1, 2018

Primary Completion

September 1, 2019

Study Completion

October 1, 2019

Last Updated

October 9, 2020

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations