Heart Valve DiseasesPORTNCT03709511
Perioperative Rehabilitation of Cardiac Valvular Surgery
A study testing Cardiac rehabilitation in people with Heart Valve Diseases and Pulmonary Complication, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
Approximately 70,000 cardiac valve surgeries are performed in China every year. Although guidelines or consensus recommendations recommend perioperative rehabilitation after valve surgery, clinical studies are still lacking, especially for Chinese patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Heart Valve Diseases, Pulmonary Complication
- What is being tested?
- Cardiac rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 30 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged from 18 to 75 years. Scheduled for elective mitral and/or aortic valve repair/replacement. New York Heart Association Classification (NYHA) I-III.
Who cannot join
- Complicated with preoperative endocarditis and/or pneumonia. Requiring emergency surgery. Enrolled in another clinical trial. Severe liver failure (Child-Turcotte-pugh classification ≥ B). Dialysis-dependent renal failure. Residual neurological and musculoskeletal impairment. Irregular vital signs (heart rate: < 40 or > 120 bpm at rest; blood pressure: systolic blood pressure > 200 mm Hg or diastolic pressure > 110 mm Hg; T: ≥ 38.5 or ≤ 36◦C; RR: >40 bpm; SpO2 ≤ 90%).
- Unwilling or unable to sign the informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong General Hospital
Guangzhou, Guangdong
Jiyan Chen, M.D., 02083827812, chenjiyandr@126.com
Jiyan Chen, M.D.
About this study
Official title: A Randomized, Open-label, Controlled Trial on Perioperative Rehabilitation of Cardiac Valvular Surgery
Approximately 70,000 cardiac valve surgeries are performed in China every year. Although guidelines or consensus recommendations recommend perioperative rehabilitation after valve surgery, clinical studies are still lacking, especially for Chinese patients. The investigators hope to find out whether a comprehensive cardiac rehabilitation program can improve the postoperative mortality, complications and length of stay m as well as anxiety, depression and quality of life, after heart valve surgery. A singlecenter, randomized clinical trial, PORT study, aims to investigate whether cardiac rehabilitation in addition to usual care is superior to treatment as usual after heart valve surgery. The trial will randomly allocate 800 patients after inclusion screening, 1:1 intervention to control group, using central randomization, and blinded outcome assessment and statistical analyses. The intervention consists of rehabilitation education, inspiratory muscle training (IMT), active cycle of breathing techniques (ACBT), and early mobilization (EM). The primary outcome of this study will be a composite of in-hospital all-cause mortality, the incidence of postoperative pulmonary complications, and the ratio of postoperative hospitalization > 7 days. The secondary outcomes will be (1) SICU days of stay; (2) days of bed rest; (3) days of hospital length of stay; (4) all-cause death in 3 months; (5) anxiety measured by Generalized Anxiety Disorder scale (GAD-7) and depression measured by Patient Health Questionnaire-9 (PHQ-9) in 3 months. (6) quality of life measured by the Short Form 36 (SF-36) in 3 months.
Read the detailed description
The PORT study is a randomized, open-label, controlled trial using assessor blinding and intention-to-treat analysis. To date, no high-quality study has prospectively examined the impact of perioperative CR in the Chinese population undergoing cardiac surgery. Thus, the PORT trial has been designed to address a cardiac rehabilitation study in line with the actual situation in China. The investigators have used the Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT) guidelines in reporting this clinical trial.
Eligible patients are invited to a face-to-face meeting to confirm study eligibility and introduce the study objectives. The screened candidates will sign the written informed consent after they confirm their willingness to participate. Baseline data are collected subsequently. Then, the intervention group will receive perioperative rehabilitation interventions targeted at the optimization of the postoperative outcomes, This specialized approach, the PORT protocol, contains four key elements: education, inspiratory muscle training (IMT), active cycle of breathing techniques (ACBT), and early mobilization (EM). Patients will be evaluated during hospitalization for study outcomes and 3 months after surgery.
After collection of baseline data, central randomization is conducted on a web-based interface (http://crdms.echobelt.org/) using a computer-generated randomized treatment allocation schedule. The randomization is stratified based on patients' age (<60, 60-75, and >75 years), left ventricular ejection fraction (<40%, 40%-50%, and >50%), and lung function (GOLD stage 1, 2, 3 and 4) with a permuted scheme with blocks of varying sizes, which is concealed from the investigators to avoid selection bias. Thus, neither investigators and patients nor relatives can influence the group the patients are allocated. Personal information about potential and enrolled patients will be collected electronically and shared in a database accessible only within the project group for those responsible for patient inclusion, in order to protect confidentiality before, during, and after the trial.
The investigators are performing a randomized trial stating that the mean in the intervention and the control groups are the same with a power of 95%, and a type I error probability of 5%. Data from the pilot study (to be submitted) showed that the incidence in the primary endpoint was 13.56% (intervention group) versus 21.21% (control group). The inclusion of 400 participants is needed in the experimental intervention group, and 400 in the control group (a total of 800 participants) to be able to reject the null hypothesis. The trial will randomly allocate 800 patients, 1:1 intervention to the control group, using central randomization, blinded outcome assessment, and statistical analyses. The intervention consists of education, inspiratory muscle training (IMT), active cycle of breathing techniques (ACBT), and early mobilization (EM), intervention versus treatment as usual, with blinded outcome assessment.
- Conditions
- Heart Valve Diseases, Pulmonary Complication
- Being tested
- Cardiac rehabilitation
- Keywords
- Heart valve surgery, Rehabilitation, Physical exercise, Psycho-education
- Medical subject headings
- Heart Valve Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac rehabilitationOther
perioperative rehabilitation consists of education, inspiratory muscle training, active cycle of breathing techniques, and early mobilization.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Treatment Group | No intervention | Participants in the control group will receive the usual care protocol. On the day of admission, a registered nurse in cardiac ward will provide operating skills of deep breathing, cough exercises, and incentive spirometry, then patients will be instructed to perform the respiratory exercise as much as they can during the hospitalization without supervision. These participants will not receive additional rehabilitation interventions, unless individual indications are present. |
| Cardiac Rehabilitation Group | Active comparator | The intervention group will receive the PORT protocol, contains education, IMT, ACBT, EM. Participants will be provided information about the cardiac surgery and adverse effect on postoperative recovery, and the importance of PORT program.
An inspiratory threshold-loading device is used for IMT. Participants will be instructed to breathe in as forcefully as possible before slowly breathing out five times and then rest for one minute, followed by another set of five breaths. Patients will complete three sessions of ACBT consisting of breathing control, thoracic expansion exercises and forced expiratory techniques. The mobilization protocol will be performed via a progressive approach, consisting of 6 steps. EM will be personalized to each patient. Receives: Other: Cardiac rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite end point of in-hospital all-cause death, pulmonary complications and the ratio of postoperative hospitalization longer than 7 days.
the composite of in-hospital all-cause death and pulmonary complications, such as pulmonary infection, postoperative hospitalization days.
Measured: Through hospitalization (up to 2 months)
Secondary outcomes (7)
incidence of all-cause death in 3 months
incidence of all-cause death at 3-month follow-up.
Measured: 3 months
Individualized Short Form-36 (SF-36) living quality Scores in 3 months
Scores from the self-administered SF-36 living quality questionnaire are measured. Higher mean scores reflect better outcomes.
Measured: 3 months
length of ICU treatment
total length of treatment at Intensive Care Unit
Measured: Through hospitalization (up to 2 months)
total length of in-hospital stays
total length of in-hospital stays
Measured: Through hospitalization (up to 2 months)
length of bed rest
length of bed rest Description: post-operative duration of bed rest until off-bed activity supervised by rehabilitation therapists.
Measured: Through hospitalization (up to 2 months)
Incidence of Treatment-Emergent Adverse Events [Emerging Arrhythmia or/and Muscle Injury or/and Acute Heart Failure]
The evaluation of Treatment-Emergent Adverse Events during hospitalization: Emerging Arrhythmia or/and Muscle Injury or/and Acute Heart Failure.
Measured: Through hospitalization (up to 2 months)
Anxiety and depression in 3 months
anxiety measured by Generalized Anxiety Disorder scale (GAD-7) and depression measured by Patient Health Questionnaire-9 (PHQ-9) in 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start1 Jan 2019
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart Valve DiseasesStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiyan Chen, Guangdong Provincial People's Hospital
- Investigators
- Jiyan Chen, M.D., Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03709511
- Sponsor's protocol ID
- GDCR2017143H
- Acronym
- PORT
- Status last verified
- Apr 2023
- First submitted
- 26 Feb 2018
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou H, Liu F, Liu Y, He X, Ma H, Xu M, Wang H, Zhang G, Cai X, Chen JY, Guo L, Chen J. Protocol for the PORT study: short-term perioperative rehabilitation to improve outcomes in cardiac valvular surgery - a randomised control trial. BMJ Open. 2023 Dec 21;13(12):e074837. doi: 10.1136/bmjopen-2023-074837.
PubMed 38135333Abraham LN, Sibilitz KL, Berg SK, Tang LH, Risom SS, Lindschou J, Taylor RS, Borregaard B, Zwisler AD. Exercise-based cardiac rehabilitation for adults after heart valve surgery. Cochrane Database Syst Rev. 2021 May 7;5(5):CD010876. doi: 10.1002/14651858.CD010876.pub3.
PubMed 33962483
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Controlled Trial on Perioperative Rehabilitation of Cardiac Valvular Surgery
- ClinicalTrials.gov ID
- NCT03709511
- Acronym / sponsor ID
- PORT / GDCR2017143H
- Conditions
- Heart Valve Diseases, Pulmonary Complication
- Keywords
- Heart valve surgery, Rehabilitation, Physical exercise, Psycho-education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 17 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Approximately 70,000 cardiac valve surgeries are performed in China every year. Although guidelines or consensus recommendations recommend perioperative rehabilitation after valve surgery, clinical studies are still lacking, especially for Chinese patients. The investigators hope to find out whether a comprehensive cardiac rehabilitation program can improve the postoperative mortality, complications and length of stay m as well as anxiety, depression and quality of life, after heart valve surgery. A singlecenter, randomized clinical trial, PORT study, aims to investigate whether cardiac rehabilitation in addition to usual care is superior to treatment as usual after heart valve surgery. The trial will randomly allocate 800 patients after inclusion screening, 1:1 intervention to control group, using central randomization, and blinded outcome assessment and statistical analyses. The intervention consists of rehabilitation education, inspiratory muscle training (IMT), active cycle of breathing techniques (ACBT), and early mobilization (EM). The primary outcome of this study will be a composite of in-hospital all-cause mortality, the incidence of postoperative pulmonary complications, and the ratio of postoperative hospitalization > 7 days. The secondary outcomes will be (1) SICU days of stay; (2) days of bed rest; (3) days of hospital length of stay; (4) all-cause death in 3 months; (5) anxiety measured by Generalized Anxiety Disorder scale (GAD-7) and depression measured by Patient Health Questionnaire-9 (PHQ-9) in 3 months. (6) quality of life measured by the Short Form 36 (SF-36) in 3 months.
Detailed description
The PORT study is a randomized, open-label, controlled trial using assessor blinding and intention-to-treat analysis. To date, no high-quality study has prospectively examined the impact of perioperative CR in the Chinese population undergoing cardiac surgery. Thus, the PORT trial has been designed to address a cardiac rehabilitation study in line with the actual situation in China. The investigators have used the Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT) guidelines in reporting this clinical trial.
Eligible patients are invited to a face-to-face meeting to confirm study eligibility and introduce the study objectives. The screened candidates will sign the written informed consent after they confirm their willingness to participate. Baseline data are collected subsequently. Then, the intervention group will receive perioperative rehabilitation interventions targeted at the optimization of the postoperative outcomes, This specialized approach, the PORT protocol, contains four key elements: education, inspiratory muscle training (IMT), active cycle of breathing techniques (ACBT), and early mobilization (EM). Patients will be evaluated during hospitalization for study outcomes and 3 months after surgery.
After collection of baseline data, central randomization is conducted on a web-based interface (http://crdms.echobelt.org/) using a computer-generated randomized treatment allocation schedule. The randomization is stratified based on patients' age (<60, 60-75, and >75 years), left ventricular ejection fraction (<40%, 40%-50%, and >50%), and lung function (GOLD stage 1, 2, 3 and 4) with a permuted scheme with blocks of varying sizes, which is concealed from the investigators to avoid selection bias. Thus, neither investigators and patients nor relatives can influence the group the patients are allocated. Personal information about potential and enrolled patients will be collected electronically and shared in a database accessible only within the project group for those responsible for patient inclusion, in order to protect confidentiality before, during, and after the trial.
The investigators are performing a randomized trial stating that the mean in the intervention and the control groups are the same with a power of 95%, and a type I error probability of 5%. Data from the pilot study (to be submitted) showed that the incidence in the primary endpoint was 13.56% (intervention group) versus 21.21% (control group). The inclusion of 400 participants is needed in the experimental intervention group, and 400 in the control group (a total of 800 participants) to be able to reject the null hypothesis. The trial will randomly allocate 800 patients, 1:1 intervention to the control group, using central randomization, blinded outcome assessment, and statistical analyses. The intervention consists of education, inspiratory muscle training (IMT), active cycle of breathing techniques (ACBT), and early mobilization (EM), intervention versus treatment as usual, with blinded outcome assessment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Treatment Group | No intervention | –Participants in the control group will receive the usual care protocol. On the day of admission, a registered nurse in cardiac ward will provide operating skills of deep breathing, cough exercises, and incentive spirometry, then patients will be instructed to perform the respiratory exercise as much as they can during the hospitalization without supervision. These participants will not receive additional rehabilitation interventions, unless individual indications are present. |
| Cardiac Rehabilitation Group | Active comparator | Other: Cardiac rehabilitationThe intervention group will receive the PORT protocol, contains education, IMT, ACBT, EM. Participants will be provided information about the cardiac surgery and adverse effect on postoperative recovery, and the importance of PORT program. An inspiratory threshold-loading device is used for IMT. Participants will be instructed to breathe in as forcefully as possible before slowly breathing out five times and then rest for one minute, followed by another set of five breaths. Patients will complete three sessions of ACBT consisting of breathing control, thoracic expansion exercises and forced expiratory techniques. The mobilization protocol will be performed via a progressive approach, consisting of 6 steps. EM will be personalized to each patient. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Aged from 18 to 75 years. Scheduled for elective mitral and/or aortic valve repair/replacement. New York Heart Association Classification (NYHA) I-III.
Key exclusion criteria (2 listed)
- Complicated with preoperative endocarditis and/or pneumonia. Requiring emergency surgery. Enrolled in another clinical trial. Severe liver failure (Child-Turcotte-pugh classification ≥ B). Dialysis-dependent renal failure. Residual neurological and musculoskeletal impairment. Irregular vital signs (heart rate: < 40 or > 120 bpm at rest; blood pressure: systolic blood pressure > 200 mm Hg or diastolic pressure > 110 mm Hg; T: ≥ 38.5 or ≤ 36◦C; RR: >40 bpm; SpO2 ≤ 90%).
- Unwilling or unable to sign the informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac rehabilitationperioperative rehabilitation consists of education, inspiratory muscle training, active cycle of breathing techniques, and early mobilization. | Other | Cardiac Rehabilitation Group |
Primary outcome
composite end point of in-hospital all-cause death, pulmonary complications and the ratio of postoperative hospitalization longer than 7 days.
Time frame: Through hospitalization (up to 2 months)
the composite of in-hospital all-cause death and pulmonary complications, such as pulmonary infection, postoperative hospitalization days.
7 secondary outcomes
incidence of all-cause death in 3 months
Time frame: 3 months
Individualized Short Form-36 (SF-36) living quality Scores in 3 months
Time frame: 3 months
length of ICU treatment
Time frame: Through hospitalization (up to 2 months)
total length of in-hospital stays
Time frame: Through hospitalization (up to 2 months)
length of bed rest
Time frame: Through hospitalization (up to 2 months)
Incidence of Treatment-Emergent Adverse Events [Emerging Arrhythmia or/and Muscle Injury or/and Acute Heart Failure]
Time frame: Through hospitalization (up to 2 months)
Anxiety and depression in 3 months
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Derived from this study: PubMed 38135333Zhou H, Liu F, Liu Y, He X, Ma H, Xu M, Wang H, Zhang G, Cai X, Chen JY, Guo L, Chen J. Protocol for the PORT study: short-term perioperative rehabilitation to improve outcomes in cardiac valvular surgery - a randomised control trial. BMJ Open. 2023 Dec 21;13(12):e074837. doi: 10.1136/bmjopen-2023-074837.
- Derived from this study: PubMed 33962483Abraham LN, Sibilitz KL, Berg SK, Tang LH, Risom SS, Lindschou J, Taylor RS, Borregaard B, Zwisler AD. Exercise-based cardiac rehabilitation for adults after heart valve surgery. Cochrane Database Syst Rev. 2021 May 7;5(5):CD010876. doi: 10.1002/14651858.CD010876.pub3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiyan Chen, M.D. principal investigator
Guangdong Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac rehabilitation in people with Heart Valve Diseases and Pulmonary Complication, run by Guangdong Provincial People's Hospital at 1 site in China.
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 1 inclusion and 2 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 12 Apr 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 China. 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 Jiyan Chen, M.D. (02083827812, chenjiyandr@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composite end point of in-hospital all-cause death, pulmonary complications and the ratio of postoperative hospitalization longer than 7 days. (time frame: Through hospitalization (up to 2 months)). 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 NCT03709511, which also lists 2 linked publications.
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 12 Apr 2023.