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Coronary Artery DiseaseNCT05474339

The Effects of Cardiac Rehabilitation on Sleep Quality and Sleep Duration in Patients After Coronary Artery Bypass Graft

A study testing Cardiac rehabilitation in people with Coronary Artery Disease and Coronary Artery Bypass Graft, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 40 to 80 years
What is being tested?
Cardiac rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteTaiwan
Study dates
1 Aug 2022to 31 Dec 2023
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 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Hsien-chum Wang contact

+886-28332211 ext. 2540

whc2629278@gmail.com

Taiwan1 site, 1 recruiting

  • Shin Kong Wu Ho-Su Memorial Hospital

    Taipei

    Hsien-chum Wang, +886-28332211 ext. 2540, whc2629278@gmail.com

    Recruiting

Other trials in Taiwan

About this study

Official title: The Effects of Cardiac Rehabilitation on Sleep Quality and Sleep Duration in Patients After Coronary Artery Bypass Graft: A Randomized Control Trial

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

Read the detailed description

Coronary artery disease (CAD) is one of the common cardiovascular diseases, including myocardial infarction and unstable angina pectoris. Using the Global Burden of Disease statistical data analysis in 2020, Khan and other scholars found that the global prevalence of CAD is about 1,655 per 100,000 people, and the prevalence rate in Taiwan is about 1759 per 100,000 people, slightly higher than the global prevalence rate. Therefore, all countries in the world attach great importance to the prevention and treatment of CAD. In addition to common risk factors such as age, metabolic disease, smoking, and poor lifestyle habits such as insufficient physical activity, the literature indicates that sleep quality and sleep duration are also significantly associated with CAD. A 2011 meta-analysis by Francesco et al. pointed out that people who sleep less than 5 hours have a higher risk of CAD and are significantly associated with higher mortality rate. Patients with CAD who self-reported poor sleep quality and short sleep duration still had a high proportion after heart-related treatment. In 1993, Redeker tracked the related symptoms of patients after coronary artery bypass graft(CABG) and found that the sleep disturbance of patients did not improve, but increased. A systematic review of the literature by Liao et al. also found similar results. The sleep quality and sleep duration of patients after CABG can be improved over time, but a high proportion of patients still complain of sleep disturbance. Therefore, the influence of sleep disturbance in patients with CAD will persist, and studies have also suggested that persistent sleep disturbance will increase the readmission rate and mortality rate of patients with CAD. Therefore, it is very important to actively manage the sleep quality and sleep time of patients with CAD.

Being tested
Cardiac rehabilitation
Keywords
Coronary Artery Disease, Coronary artery bypass graft, Sleep quality, Sleep duration, Cardiac rehabilitation
Medical subject headings
Coronary Artery Disease, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiac rehabilitationOther

    Using Cardiac rehabilitation for patients after coronary artery bypass graft

Study groups in NCT05474339
Study groupRoleWhat they receive
Cardiac rehabilitation groupExperimentalNot described
Receives: Other: Cardiac rehabilitation
Control groupNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pittsburgh Sleep Quality Index (PSQI)

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

    Measured: Change between baseline and 3 mons. after cardiac rehabilitation

  2. 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)

    Measured: Change between baseline and 3 mons. after cardiac rehabilitation

Secondary outcomes (4)

  1. Epworth Sleepiness Scale (ESS)

    General level of daytime sleepiness . 8 self-rated questions. The chance of dozing is rated on a scale of 0-3. Range of 0-24, higher scores indicate worse daytime sleepiness. Scores > 10 are taken to represent excessive daytime sleepiness.

    Measured: Change between baseline and 3 mons. after cardiac rehabilitation

  2. Visual analogue scale

    Pain rating scales. Mark a 100 mm line to indicate pain intensity. 0 mm = no pain, 100 mm = worst pain

    Measured: Change between baseline and 3 mons. after cardiac rehabilitation

  3. Hospital Anxiety and Depression Scale (HADS)

    Range of 0-21, higher scores indicate worse anxiety or depression. Scores > 10 are taken to represent anxiety or depression

    Measured: Change between baseline and 3 mons. after cardiac rehabilitation

  4. Cardiopulmonary exercise testing (CPET)

    Gold standard for exercise capacity. Protocol: Starting form 0 watt, increase 10-15 watt/min. Test termination: Reach ≥ 85% of maximal HR, Respiratory exchange ratio (RER) > 1.10, Participants feel exhausted

    Measured: Change between baseline and 3 mons. after cardiac rehabilitation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2022
  2. Study start1 Aug 2022
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05474339
Sponsor's protocol ID
20220504R
Status last verified
Jul 2023
First submitted
22 Jul 2022
Last updated
28 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Cardiac rehabilitation in people with Coronary Artery Disease and Coronary Artery Bypass Graft, run by Shin Kong Wu Ho-Su Memorial Hospital 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 7 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: status not confirmed, as of the sponsor's last update on 28 Jul 2023. 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. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hsien-chum Wang (+886-28332211 ext. 2540, whc2629278@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pittsburgh Sleep Quality Index (PSQI) (time frame: Change between baseline and 3 mons. after cardiac rehabilitation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05474339.

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 28 Jul 2023.

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