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Cardiac Rehabilitation for Cardiovascular Risk in Mental Illness
N/A
Recruiting
Led By Michael J Goldfarb
Research Sponsored by Lady Davis Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if a program can reduce the risk of heart disease in those with mental illness.
Who is the study for?
This trial is for people aged 30-59 with severe mental illnesses like schizophrenia or bipolar disorder, who also have heart risk factors such as smoking, obesity, high blood pressure, diabetes, or sleep apnea. They must be at intermediate risk of heart disease and willing to join a cardiac rehab program. It's not for pregnant individuals or those with existing heart diseases.
What is being tested?
The study tests if a cardiac rehabilitation program can reduce the risk of cardiovascular disease in patients with severe mental illness. Participants will be randomly assigned to either the intervention group receiving the rehab program or a control group for comparison.
What are the potential side effects?
While specific side effects are not detailed here, typical risks associated with cardiac rehabilitation may include muscle soreness and fatigue from exercise components of the program.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Efficacy outcome
Secondary study objectives
30-year Cardiovascular risk
PRIMROSE BMI risk score
PRIMROSE Lipid risk score
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 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.
Group II: ControlActive Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cardiac Rehabilitation Program
2017
N/A
~110
Find a Location
Who is running the clinical trial?
Lady Davis InstituteLead Sponsor
48 Previous Clinical Trials
6,122 Total Patients Enrolled
Jewish General HospitalOTHER
140 Previous Clinical Trials
278,522 Total Patients Enrolled
Michael J GoldfarbPrincipal InvestigatorLady Davis Institute
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have heart, brain, or blood vessel disease.I am between 30 and 59 years old.I have two or more of the following: smoke, am obese, have high blood pressure, diabetes, metabolic syndrome, high cholesterol, or sleep apnea.I have been diagnosed with schizophrenia, schizoaffective disorder, or bipolar I disorder.I am willing to join a heart health rehab program.My heart condition is considered too risky for cardiac rehab.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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