Valvular Heart DiseaseNCT03571906
Pre-habilitation of Patients Scheduled for Cardiac Valve Surgery
A study testing Tele - Cardiac Pre-Rehabilitation in people with Valvular Heart Disease, run by Sheba Medical Center.
Trial summary
Cardiac rehabilitation (CR) is an integral part of cardiovascular disease management incorporating aspects of scientifically constructed appropriate physical exercise. CR has been repeatedly shown to significantly improve functional capacity, depression and wellbeing, even following short term interventions. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Valvular Heart Disease
- What is being tested?
- Tele - Cardiac Pre-Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jul 2018to Nov 2019
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible patients must meet all the following inclusion criteria during the initial screening visit of the study (visit 1):
- Valvular heart disease and planed surgery within the next 4-12 weeks
- Age ≥ 21
- Smartphone with internet connection
- Willing and able to comply with study protocol and
- Able to follow the personalized exercise prescription, utilize Polar watch and upload exercise data per protocol
Who cannot join
- Eligible patients must meet none of the following exclusion criteria:
- Advanced Heart failure (NYHA >3) or unresolved significant arrhythmia (i.e. symptomatic atrial fibrillation)
- Significant neurological or cognitive impairment
- Women of child-bearing potential
- Symptomatic hypotension, orthostatic hypotension or repeated blood pressure systolic value <100 mmHg without symptoms
- ACS or percutaneous coronary intervention (PCI) within 30 days prior to screening, or having undergone CABG surgery within 30 days prior to screening
Show all 14Show fewer
- Inability to perform a stress test due to physical limitations
- Severe angina pectoris as defined by CCS >2
- Pulmonary disease of severity greater than mild (COPD, Asthma, ILD, CTD with lung involvement) or chronic pulmonary thromboembolic disease (CTED)
- Severe orthopedic limitations not permitting exercise
- Active myocarditis, constrictive pericarditis, restrictive or hypertrophic cardiomyopathy
- Significant anemia (Hb < 9 mg/dl)
- Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or in the opinion of the investigator are not suitable to participate;
- Any illness which reduces life expectancy to less than 1 year from screening
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Tele - Cardiac Rehabilitation - Providing Pre-habilitation to Stable Patients With Valvular Heart Disease Awaiting Surgery
Cardiac rehabilitation (CR) is an integral part of cardiovascular disease management incorporating aspects of scientifically constructed appropriate physical exercise. CR has been repeatedly shown to significantly improve functional capacity, depression and wellbeing, even following short term interventions. Functional capacity is closely related to frailty, a key prognostic factor in subjects undergoing cardiac surgery. We intend to enroll 50 stable subjects with valvular heart disease scheduled for surgical intervention. Our hypothesis is that the Prehab group will improve their functional capacity to a greater degree than the usual care group, possibly associated with better clinical outcomes.
Read the detailed description
Cardiac rehabilitation (CR) is an integral part of cardiovascular disease management incorporating aspects of scientifically constructed appropriate physical exercise, dietary intervention, secondary prevention by pharmacotherapy, and psychological intervention. CR has been repeatedly shown to significantly improve functional capacity, depression and wellbeing, even following short term interventions (6-8 weeks in accordance with the date of surgery determined for the patient.) Functional capacity is closely related to frailty, a key prognostic factor in subjects undergoing cardiac surgery. Small studies have demonstrated possible benefits of pre-habilitation - a multidisciplinary intervention aimed at improving frailty in the weeks prior to surgery.
We intend to enroll 50 stable subjects with valvular heart disease scheduled for surgical intervention. Following a comprehensive clinical and physiological evaluation subjects will be randomized (1:1) to a Prehab arm (PHB) vs. usual care (UC). Subjects in the prehab arm will receive a hybrid institution and home-based exercise prescription, nutritional and psychological intervention and periodic calls. Adherence will be assessed and encouraged by smartwatch and matching smartphone software. In the usual care arm subjects will receive general recommendations following the baseline stress test performed by both groups (prehab is not standard of care or guideline based). Another stress test will be performed days prior to valve surgery.
Our hypothesis is that the Prehab group will improve their functional capacity to a greater degree than the usual care group, possibly associated with better clinical outcomes.
The primary efficacy outcome will be exercise capacity (assessed by symptom limited stress test - estimated METS) change from baseline (enrollment) to pre-surgery evaluation visit (pre-op test).
Secondary measures:
Compare the 2 study arms in regard to:
- Length of ICU and hospital stay
- Perioperative adverse events
- 30-day mortality or re-hospitalization
- QOL and satisfaction
Patient / Group numbers: A total of 50 patients with established valvular disease will be enrolled to PHB or UC after eligibility verification by cardiothoracic surgeon
Hardware: Standard off the shelf Polar sports watch (M430) with matching smartphone software. No clinical or identifiable data will be inputted into these systems (coded subject ID only).
Clinical data and the entire program will be managed through the hospital electronic medical record (EMR). All clinical decisions \ recommendations and events will be recorded in the EMR.
Intervention: Patients will be randomized to pre-operative usual care or rehabilitation program comprising of on-site (Sheba MC) and off-site training sessions. Adherence to the rehab program will be assessed and a structured motivational program and follow-up will be provided in order to maximize goal completion.
Following the standard rehabilitation intake process (stress test, physician visit, nurse intake), the subjects in the prehab arm will receive physiologic consultation based on clinical stress tests and clinical data passed from the physician. Subjects in the prehab arm will receive an exercise prescription and execution will be assessed and periodically adjusted in accordance to data received from the wearable device. Intensity and type of exercise will be moderate and will comply with exercise recommendations provided by ESC guidelines. A dedicated application will be installed on the mobile phone for patients in the research group and they will receive a smart sports watch.
Periodic encouragements and consultations will be provided by exercise trainer, physiologist and nurse from the cardiac rehabilitation center. A physician will be available for consultations.
In addition to monitored physical activity, patients will receive nutritional and psychological counseling. This is part of a multi-professional rehabilitation program accepted by the rehabilitation center.
The control group will receive recommendations for a healthy and active lifestyle and physician follow-up
All subjects will undergo a stress test at baseline post enrollment and again prior to surgery.
- Conditions
- Valvular Heart Disease
- Being tested
- Tele - Cardiac Pre-Rehabilitation
- Keywords
- Rehabilitation
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele - Cardiac Pre-RehabilitationBehavioural
Also called Pre-rehab program
We intend to enroll 50 stable subjects with valvular heart disease scheduled for surgical intervention. Following a comprehensive clinical and physiological evaluation subjects will be randomized (1:1) to a Prehab arm (PHB) vs. usual care (UC). Subjects in the prehab arm will receive a hybrid institution and home-based exercise prescription, nutritional and psychological intervention and periodic calls. Adherence will be assessed and encouraged by smartwatch and matching smartphone software. In the usual care arm subjects will receive general recommendations following the baseline stress test performed by both groups (prehab is not standard of care or guideline based). Another stress test will be performed days prior to valve surgery Adherence to the rehab program will be assessed and a structured motivational program and follow-up will be provided in order to maximize goal completion.
| Study group | Role | What they receive |
|---|---|---|
| Pre-rehab intervention | Experimental | Subjects in the prehab arm will receive an exercise prescription and execution will be assessed and periodically adjusted in accordance to data received from the wearable device. Intensity and type of exercise will be moderate and will comply with exercise recommendations provided by ESC guidelines. A dedicated application will be installed on the mobile phone for patients in the research group and they will receive a smart sports watch.
Periodic encouragements and consultations will be provided by exercise trainer, physiologist and nurse from the cardiac rehabilitation center. A physician will be available for consultations.
In addition to monitored physical activity, patients will receive nutritional and psychological counseling. This is part of a multi-professional rehabilitation program accepted by the rehabilitation center. Receives: Behavioral: Tele - Cardiac Pre-Rehabilitation |
| pre-operative usual care arm | No intervention | The control group will receive recommendations for a healthy and active lifestyle and physician follow-up All subjects will undergo a stress test at baseline (post enrollment), and again prior to cardiac surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in METS
Exercise capacity change as assessed by stress test
Measured: 6-8 weeks
Secondary outcomes (3)
Hospitalisation duration
Total hospital stay
Measured: 2 weeks peri-op
ICU duration
Time spent in the post operation ICU unit
Measured: 2 weeks peri-op
Peri operative complication
Occurrence of adverse events including pneumonia, bleeding, atrial fibrillation, Other infections
Measured: 2 weeks peri-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study startJul 2018 (estimated)
- Primary completionJul 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valvular Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Robert Klempfner Heart Rehabilitation Institute, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571906
- Sponsor's protocol ID
- 4517-17-SMC
- Status last verified
- Jun 2018
- First submitted
- 19 Jun 2018
- Last updated
- 28 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele - Cardiac Rehabilitation - Providing Pre-habilitation to Stable Patients With Valvular Heart Disease Awaiting Surgery
- ClinicalTrials.gov ID
- NCT03571906
- Acronym / sponsor ID
- 4517-17-SMC
- Conditions
- Valvular Heart Disease
- Keywords
- Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jul 2018 (estimated)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 28 Jun 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.
Cardiac rehabilitation (CR) is an integral part of cardiovascular disease management incorporating aspects of scientifically constructed appropriate physical exercise. CR has been repeatedly shown to significantly improve functional capacity, depression and wellbeing, even following short term interventions. Functional capacity is closely related to frailty, a key prognostic factor in subjects undergoing cardiac surgery. We intend to enroll 50 stable subjects with valvular heart disease scheduled for surgical intervention. Our hypothesis is that the Prehab group will improve their functional capacity to a greater degree than the usual care group, possibly associated with better clinical outcomes.
Detailed description
Cardiac rehabilitation (CR) is an integral part of cardiovascular disease management incorporating aspects of scientifically constructed appropriate physical exercise, dietary intervention, secondary prevention by pharmacotherapy, and psychological intervention. CR has been repeatedly shown to significantly improve functional capacity, depression and wellbeing, even following short term interventions (6-8 weeks in accordance with the date of surgery determined for the patient.) Functional capacity is closely related to frailty, a key prognostic factor in subjects undergoing cardiac surgery. Small studies have demonstrated possible benefits of pre-habilitation - a multidisciplinary intervention aimed at improving frailty in the weeks prior to surgery.
We intend to enroll 50 stable subjects with valvular heart disease scheduled for surgical intervention. Following a comprehensive clinical and physiological evaluation subjects will be randomized (1:1) to a Prehab arm (PHB) vs. usual care (UC). Subjects in the prehab arm will receive a hybrid institution and home-based exercise prescription, nutritional and psychological intervention and periodic calls. Adherence will be assessed and encouraged by smartwatch and matching smartphone software. In the usual care arm subjects will receive general recommendations following the baseline stress test performed by both groups (prehab is not standard of care or guideline based). Another stress test will be performed days prior to valve surgery.
Our hypothesis is that the Prehab group will improve their functional capacity to a greater degree than the usual care group, possibly associated with better clinical outcomes.
The primary efficacy outcome will be exercise capacity (assessed by symptom limited stress test - estimated METS) change from baseline (enrollment) to pre-surgery evaluation visit (pre-op test).
Secondary measures:
Compare the 2 study arms in regard to:
- Length of ICU and hospital stay
- Perioperative adverse events
- 30-day mortality or re-hospitalization
- QOL and satisfaction
Patient / Group numbers: A total of 50 patients with established valvular disease will be enrolled to PHB or UC after eligibility verification by cardiothoracic surgeon
Hardware: Standard off the shelf Polar sports watch (M430) with matching smartphone software. No clinical or identifiable data will be inputted into these systems (coded subject ID only).
Clinical data and the entire program will be managed through the hospital electronic medical record (EMR). All clinical decisions \ recommendations and events will be recorded in the EMR.
Intervention: Patients will be randomized to pre-operative usual care or rehabilitation program comprising of on-site (Sheba MC) and off-site training sessions. Adherence to the rehab program will be assessed and a structured motivational program and follow-up will be provided in order to maximize goal completion.
Following the standard rehabilitation intake process (stress test, physician visit, nurse intake), the subjects in the prehab arm will receive physiologic consultation based on clinical stress tests and clinical data passed from the physician. Subjects in the prehab arm will receive an exercise prescription and execution will be assessed and periodically adjusted in accordance to data received from the wearable device. Intensity and type of exercise will be moderate and will comply with exercise recommendations provided by ESC guidelines. A dedicated application will be installed on the mobile phone for patients in the research group and they will receive a smart sports watch.
Periodic encouragements and consultations will be provided by exercise trainer, physiologist and nurse from the cardiac rehabilitation center. A physician will be available for consultations.
In addition to monitored physical activity, patients will receive nutritional and psychological counseling. This is part of a multi-professional rehabilitation program accepted by the rehabilitation center.
The control group will receive recommendations for a healthy and active lifestyle and physician follow-up
All subjects will undergo a stress test at baseline post enrollment and again prior to surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-rehab intervention | Experimental | Behavioral: Tele - Cardiac Pre-RehabilitationSubjects in the prehab arm will receive an exercise prescription and execution will be assessed and periodically adjusted in accordance to data received from the wearable device. Intensity and type of exercise will be moderate and will comply with exercise recommendations provided by ESC guidelines. A dedicated application will be installed on the mobile phone for patients in the research group and they will receive a smart sports watch. Periodic encouragements and consultations will be provided by exercise trainer, physiologist and nurse from the cardiac rehabilitation center. A physician will be available for consultations. In addition to monitored physical activity, patients will receive nutritional and psychological counseling. This is part of a multi-professional rehabilitation program accepted by the rehabilitation center. |
| pre-operative usual care arm | No intervention | –The control group will receive recommendations for a healthy and active lifestyle and physician follow-up All subjects will undergo a stress test at baseline (post enrollment), and again prior to cardiac surgery. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Eligible patients must meet all the following inclusion criteria during the initial screening visit of the study (visit 1):
- Valvular heart disease and planed surgery within the next 4-12 weeks
- Age ≥ 21
- Smartphone with internet connection
- Willing and able to comply with study protocol and
Key exclusion criteria (14 listed)
- Advanced Heart failure (NYHA >3) or unresolved significant arrhythmia (i.e. symptomatic atrial fibrillation)
- Significant neurological or cognitive impairment
- Women of child-bearing potential
- Symptomatic hypotension, orthostatic hypotension or repeated blood pressure systolic value <100 mmHg without symptoms
- ACS or percutaneous coronary intervention (PCI) within 30 days prior to screening, or having undergone CABG surgery within 30 days prior to screening
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 |
|---|---|---|
| Tele - Cardiac Pre-RehabilitationAlso: Pre-rehab programWe intend to enroll 50 stable subjects with valvular heart disease scheduled for surgical intervention. Following a comprehensive clinical and physiological evaluation subjects will be randomized (1:1) to a Prehab arm (PHB) vs. usual care (UC). Subjects in the prehab arm will receive a hybrid institution and home-based exercise prescription, nutritional and psychological intervention and periodic calls. Adherence will be assessed and encouraged by smartwatch and matching smartphone software. In the usual care arm subjects will receive general recommendations following the baseline stress test performed by both groups (prehab is not standard of care or guideline based). Another stress test will be performed days prior to valve surgery Adherence to the rehab program will be assessed and a structured motivational program and follow-up will be provided in order to maximize goal completion. | Behavioural | Pre-rehab intervention |
Primary outcome
Change in METS
Time frame: 6-8 weeks
Exercise capacity change as assessed by stress test
3 secondary outcomes
Hospitalisation duration
Time frame: 2 weeks peri-op
ICU duration
Time frame: 2 weeks peri-op
Peri operative complication
Time frame: 2 weeks peri-op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
Related trials for Valvular Heart Disease
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingObservational study
A Post-Market Assessment of the Safety and Performance of the TriClip™ System
Tricuspid Regurgitation (TR)
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
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.
Questions about this trial
What is this clinical trial studying?
A study testing Tele - Cardiac Pre-Rehabilitation in people with Valvular Heart Disease, run by Sheba Medical Center.
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 6 inclusion and 14 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 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Robert Klempner, Prof. (97235303068, Robert.Klempfner@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in METS (time frame: 6-8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2018.