Cardiac Rehabilitation for Cardiovascular Risk Reduction in People With Severe and Persistent Mental Illness

Study Overview
=================
Brief Summary
-----------------
The goal of this prospective, randomized trial is to explore the link between cardiovascular disease and mortality in individuals with severe and persistent mental illness (SPMI). The main question it aims to answer is: Is a primary prevention cardiac rehabilitation intervention feasible and effective at reducing cardiovascular risk in people with a primary psychotic disorder or bipolar disorder? Participants will undergo a multi-component primary prevention intervention program. Researchers will compare with a control group to see if cardiovascular risk reduction is attained.

Detailed Description
-----------------
This prospective, randomized study aims to recruit 46 adults with schizophrenia, schizoaffective disorder, or bipolar disorder, who are classified as intermediate or high 10-year risk for a cardiovascular event, into a multi-component cardiac rehabilitation intervention program. The aim is to explore the feasibility and efficacy of this multi-component primary prevention intervention program in reducing cardiovascular risk in individuals with SPMI. Evidence supports a high burden of cardiovascular disease and mortality in individuals with SPMI. In link, multiple studies outline disparities in access to quality cardiovascular care in people with SPMI. Given the high CV risk factor burden in people with SPMI and the disparity in access and quality of care, there is a need to screen for CV risk factors and initiate and monitor guideline-directed therapies in people with SPMI. Intervention outcomes will be measured using the Framingham 10-year cardiovascular risk score, the Framingham 30-year cardiovascular risk score, the PRIMOSE BMI and Lipid risk scores, the EQ-5D-5L scale and the CGI score. Continuous variables will be displayed as means, with associated standard deviations. Categorical variables will be represented as frequencies and percentages. Subsequent comparative analysis will take place, where the overall cohort will be characterized into high risk (top quartile) and low risk (bottom quartile) cohorts. This will be accomplished using the chi-squared test or the Fisher exact test, along with the student's t test and the Mann-Whitney U test when appropriate. SPSS 24.0 will be the statistical software used.

Official Title
-----------------
Cardiac Rehabilitation for Cardiovascular Risk Reduction in People With Severe and Persistent Mental Illness: A Pilot Randomized Study

Conditions
-----------------
Mental Illness Persistent, Cardiovascular Prevention

Intervention / Treatment
-----------------
* Behavioral: Cardiac Rehabilitation Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 30 to 59 years old Psychiatric diagnosis of schizophrenia, schizoaffective disorder, or bipolar I disorder 2 or more cardiac risk behaviors or conditions: smoking, obese, hypertension, diabetes, metabolic syndrome, dyslipidemia, obstructive sleep apnea 10-year Framingham cardiovascular risk score of ≥ 10% (intermediate risk) Willing to participate in cardiac rehabilitation program Exclusion Criteria: Psychiatric instability, as judged by treating psychiatrist Distance from cardiac rehabilitation centre that would preclude participation Unsafe to participate in the cardiac rehabilitation intervention, as judged by the cardiology assessment Pregnant Known coronary artery disease, cerebrovascular disease, or peripheral vascular disease Court ordered mandatory or tutor

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 59 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The standard cardiac rehabilitation program consists of the following: a (1) consultation with a kinesiologist to assess level of fitness and to prepare an individually customized exercise plan, (2) consultation with a dietitian to guide the participant with healthy nutrition choices, (3) on site supervised and/or virtual exercise sessions with gradual elaboration of a home program, (4) weekly educational capsules and monthly workshops related to cardiac health, and, (5) if deemed necessary by the treating team, consultation with a psychologist, an occupational therapist, a physiotherapist, or a social worker. | Behavioral: Cardiac Rehabilitation Program<br>* The standard cardiac rehabilitation program consists of the following: a (1) consultation with a kinesiologist to assess level of fitness and to prepare an individually customized exercise plan, (2) consultation with a dietitian to guide the participant with healthy nutrition choices, (3) on site supervised and/or virtual exercise sessions with gradual elaboration of a home program, (4) weekly educational capsules and monthly workshops related to cardiac health, and, (5) if deemed necessary by the treating team, consultation with a psychologist, an occupational therapist, a physiotherapist, or a social worker.<br>|
| No Intervention: Control<br>Participants in the control group will receive educational information on maintaining optimal cardiovascular health. Participants will be encouraged to undergo 30 minutes of moderate-intensity aerobic activity at least 5 days per week. Participants will be given educational materials on recommended diet and exercise. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy outcome | 10-year Framingham cardiovascular risk score | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-year Cardiovascular risk | 30-year Framingham cardiovascular risk score | 9 months | 
| PRIMROSE BMI risk score | PRIMROSE BMI risk score | 9 months | 
| PRIMROSE Lipid risk score | PRIMROSE Lipid risk score | 9 months | 
| Quality of life | EQ-5D-5L | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Severe and persistent mental illness, Primary prevention, Measures, Schizophrenia, Schizoaffective disorder, Bipolar disorder