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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

Study 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.Check my eligibility

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.See study design

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Efficacy outcome

Secondary outcome measures

30-year Cardiovascular risk

PRIMROSE BMI risk score

PRIMROSE Lipid risk score

+1 more

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Lady Davis InstituteLead Sponsor

44 Previous Clinical Trials

5,474 Total Patients Enrolled

Jewish General HospitalOTHER

137 Previous Clinical Trials

271,998 Total Patients Enrolled

Michael J GoldfarbPrincipal InvestigatorLady Davis Institute

Media Library

Cardiac Rehabilitation Program Clinical Trial Eligibility Overview. Trial Name: NCT05659498 — N/A

Mental Illness Research Study Groups: Intervention, Control

Mental Illness Clinical Trial 2023: Cardiac Rehabilitation Program Highlights & Side Effects. Trial Name: NCT05659498 — N/A

Cardiac Rehabilitation Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT05659498 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research initiative recruiting participants who are of a more advanced age?

"This medical trial is seeking out participants aged 30 and above, but below the age of 59."

Answered by AI

Are there any remaining slots available for participants in this trial?

"Affirmative. Clinicaltrials.gov's information indicates that the trial is actively looking for participants, having been first posted on December 14th 2022 and last updated 12 days later. 46 patients need to be sourced from 1 medical site."

Answered by AI

To what extent are people being administered treatments as part of this clinical trial?

"Correct. Clinicaltrials.gov records display that this clinical trial is actively searching for participants, having been first posted on December 14th 2022 and last modified on the 12th of December 2022. The research team needs to find 46 individuals from 1 site in order to conduct their investigation adequately."

Answered by AI

Is the opportunity to join this research experiment open for participation?

"This health trial is seeking 46 adult patients between 30-59 years of age that are currently living with a psychiatric disorder. Eligible participants must have diagnoses such as schizophrenia, schizoaffective disorder, or bipolar I disorder and two or more cardiovascular risk factors like smoking, obesity, hypertension, diabetes among others; a 10-year Framingham Cardiovascular Risk Score of at least 10%, and must consent to take part in cardiac rehabilitation program."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Michael Goldfarb 2022. "Cardiac Rehabilitation for Cardiovascular Risk Reduction in People With Severe and Persistent Mental Illness". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05659498.

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