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

NCT05659498 | Unknown

• 1 other identifier: 20233395
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Illness Persistent; Cardiovascular Prevention

Keywords

Severe and persistent mental illness; Primary prevention; Measures; Schizophrenia; Schizoaffective disorder; Bipolar disorder

Outcome Measures

Primary Outcomes (1)

• Efficacy outcome

  10-year Framingham cardiovascular risk score

  9 months

Secondary Outcomes (4)

• 30-year Cardiovascular risk

  9 months

• PRIMROSE BMI risk score

  9 months

• PRIMROSE Lipid risk score

  9 months

• Quality of life

  9 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Cardiac Rehabilitation Program BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 30 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥ 30 to 59 years old
• Psychiatric diagnosis of schizophrenia, schizoaffective disorder, or bipolar I disorder
• or more cardiac risk behaviors or conditions: smoking, obese, hypertension, diabetes, metabolic syndrome, dyslipidemia, obstructive sleep apnea
• year Framingham cardiovascular risk score of ≥ 10% (intermediate risk)
• Willing to participate in cardiac rehabilitation program

You may not qualify if:

• 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

Sponsors & Collaborators

• Lady Davis Institute: lead
• Jewish General Hospital: collaborator

Study Sites (1)

Jewish General Hospital/Lady Davis Institute

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

Related 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.

  PMID: 32530472 BACKGROUND

• 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.

  PMID: 33128044 BACKGROUND

• 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.

  PMID: 36007991 BACKGROUND

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Bipolar Disorder

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders

Study Officials

• Michael J Goldfarb

  Lady Davis Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael J Goldfarb, MD MSc

CONTACT

5143408222; michael.j.goldfarb@mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Masking the participant and provider is not possible due to the nature of the intervention
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Staff, Division of Cardiology

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 21, 2022
• Study Start: December 14, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: March 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)