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

Cardiovascular Prevention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05659498
• Other study ID #: 20233395
• Status: Recruiting
• Phase: N/A
• Start date: December 14, 2022
• Est. completion date: May 2024

Study information

• Verified date: March 2023
• Source: Lady Davis Institute
• Contact: Michael J Goldfarb, MD MSc
• Phone: 5143408222
• Email: michael.j.goldfarb[@]mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Prevention
• Mental Disorders
• Mental Illness Persistent

Intervention

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.

Locations

Country	Name	City	State
Canada	Jewish General Hospital/Lady Davis Institute	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Lady Davis Institute	Jewish General Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy outcome	10-year Framingham cardiovascular risk score	9 months
Secondary	30-year Cardiovascular risk	30-year Framingham cardiovascular risk score	9 months
Secondary	PRIMROSE BMI risk score	PRIMROSE BMI risk score	9 months
Secondary	PRIMROSE Lipid risk score	PRIMROSE Lipid risk score	9 months
Secondary	Quality of life	EQ-5D-5L	9 months