NCT05474339

Brief Summary

This study aims to investigate the effects of cardiac rehabilitation on sleep quality and sleep duration in patients after coronary artery bypass graft.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 26, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

July 28, 2023

Status Verified

July 1, 2023

Enrollment Period

1.4 years

First QC Date

July 22, 2022

Last Update Submit

July 26, 2023

Conditions

Coronary Artery DiseaseCoronary Artery Bypass GraftSleep QualityCardiac Rehabilitation

Keywords

Coronary Artery DiseaseCoronary artery bypass graftSleep qualitySleep durationCardiac rehabilitation

Outcome Measures

Primary Outcomes (2)

  • Pittsburgh Sleep Quality Index (PSQI)

    Range of 0-21, higher scores indicate worse sleep quality. Scores \> 5 are taken to represent poor sleep quality

    Change between baseline and 3 mons. after cardiac rehabilitation

  • Actigraphy

    Objective sleep parameter. Wear on the non-dominant wrist for 24 hrs. Can measure the total sleep time (TST), sleep onset latency (SOL), wake after sleep onset (WASO), sleep efficiency (SE)

    Change between baseline and 3 mons. after cardiac rehabilitation

Secondary Outcomes (4)

  • Epworth Sleepiness Scale (ESS)

    Change between baseline and 3 mons. after cardiac rehabilitation

  • Visual analogue scale

    Change between baseline and 3 mons. after cardiac rehabilitation

  • Hospital Anxiety and Depression Scale (HADS)

    Change between baseline and 3 mons. after cardiac rehabilitation

  • Cardiopulmonary exercise testing (CPET)

    Change between baseline and 3 mons. after cardiac rehabilitation

Study Arms (2)

Cardiac rehabilitation group

EXPERIMENTAL
Other: Cardiac rehabilitation

Control group

NO INTERVENTION

Interventions

Cardiac rehabilitationOTHER

Using Cardiac rehabilitation for patients after coronary artery bypass graft

Cardiac rehabilitation group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 40-80 years old
  • Have undergone CABG
  • The score of PSQI \> 5
  • Can accomplish with instructions and complete the evaluation process
  • Body mass index less than 35 Kg/m2

You may not qualify if:

  • Diagnosed with
  • Sleep apnea (e.g., obstructive sleep apnea, and central sleep apnea)
  • Drug or alcohol dependence
  • Psychology disease
  • Neurological or musculoskeletal disorders that may interfere with CR
  • Uncontrolled cardiac status (e.g., unstable angina, and uncontrolled arrhythmia)
  • Women in pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Coronary Artery DiseaseSleep Initiation and Maintenance Disorders

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Hsien-Chum Wang

    Shin Kong Wu Ho-Su Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsien-chum Wang

CONTACT

+886-28332211whc2629278@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical therapy

Study Record Dates

First Submitted

July 22, 2022

First Posted

July 26, 2022

Study Start

August 1, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

July 28, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)