Pre-habilitation of Patients Scheduled for Cardiac Valve Surgery

NCT03571906 | Unknown

• 1 other identifier: 4517-17-SMC
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Valvular Heart Disease

Keywords

Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in METS

  Exercise capacity change as assessed by stress test

  6-8 weeks

Secondary Outcomes (3)

• Hospitalisation duration

  2 weeks peri-op

• ICU duration

  2 weeks peri-op

• Peri operative complication

  2 weeks peri-op

Study Arms (2)

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.

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.

Interventions

Tele - Cardiac Pre-Rehabilitation BEHAVIORAL

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.

Also known as: Pre-rehab program

Pre-rehab intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Sheba Medical Center: lead

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Robert Klempner, Prof.

CONTACT

97235303068; Robert.Klempfner@sheba.health.gov.il

Merav Moreno

CONTACT

97235303068; merav.moreno@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Klempfner

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: June 28, 2018
• Study Start: July 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: November 1, 2019
• Last Updated: June 28, 2018

Record last verified: 2018-06