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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Mental Illness Persistent; Cardiovascular Prevention
• Intervention / Treatment: Behavioral: Cardiac Rehabilitation Program

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.

• Study Type: Interventional
• Enrollment (Anticipated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael J Goldfarb, MD MSc; Phone Number: 5143408222; Email: michael.j.goldfarb@mcgill.ca

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H3T 1E2
      • Recruiting
      • Jewish General Hospital/Lady Davis Institute
      • Contact: Michael J Goldfarb, MD MSc; Phone Number: 514-340-8222; Email: michael.j.goldfarb@mcgill.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 59 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; 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.
No Intervention: Control; 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

Collaborators and Investigators

• Sponsor: Lady Davis Institute
• Collaborators: Jewish General Hospital
• Investigators: Principal Investigator: Michael J Goldfarb, Lady Davis Institute

Publications and helpful links

General Publications

• Daumit GL, Dalcin AT, Dickerson FB, Miller ER, Evins AE, Cather C, Jerome GJ, Young DR, Charleston JB, Gennusa JV 3rd, Goldsholl S, Cook C, Heller A, McGinty EE, Crum RM, Appel LJ, Wang NY. Effect of a Comprehensive Cardiovascular Risk Reduction Intervention in Persons With Serious Mental Illness: A Randomized Clinical Trial. JAMA Netw Open. 2020 Jun 1;3(6):e207247. doi: 10.1001/jamanetworkopen.2020.7247.
• Nielsen RE, Banner J, Jensen SE. Cardiovascular disease in patients with severe mental illness. Nat Rev Cardiol. 2021 Feb;18(2):136-145. doi: 10.1038/s41569-020-00463-7. Epub 2020 Oct 30.
• Goldfarb M, De Hert M, Detraux J, Di Palo K, Munir H, Music S, Pina I, Ringen PA. Severe Mental Illness and Cardiovascular Disease: JACC State-of-the-Art Review. J Am Coll Cardiol. 2022 Aug 30;80(9):918-933. doi: 10.1016/j.jacc.2022.06.017.

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2022
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: December 12, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: March 8, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Schizophrenia; Primary prevention; Bipolar disorder; Schizoaffective disorder; Measures; Severe and persistent mental illness
• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: 20233395

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No