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Prehabilitation for Frail Patients Awaiting Cardiac Surgery

N/A

Recruiting

Led By Kelly Codispodi, BMR PT

Research Sponsored by Dr. Todd A Duhamel

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults (≥ 18 years of age) undergoing elective isolated coronary artery bypass graft (CABG), aortic valve repair or replacement for moderate aortic stenosis or severe regurgitation, mitral valve repair or replacement for moderate stenosis or severe regurgitation or combined CABG/valve procedures

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up completed at baseline and end of week 3

Awards & highlights

Study Summary

This trial is to determine if a home-based exercise program supported virtually by a physiotherapist is feasible for frail adults awaiting cardiac surgery.

Who is the study for?

This trial is for adults over 18 awaiting elective cardiac surgery with a Clinical Frailty Score of 3-6, able to wait at least 3 weeks, and have internet access plus a device for video calls. They need a support person available during all exercise sessions who can assist technically and physically if needed.Check my eligibility

What is being tested?

The study tests the feasibility of a home-based exercise program supported virtually by physiotherapists for frail patients before cardiac surgery. It checks patient interest, practicality of exercises prescribed thrice weekly, quality of virtual instruction, and safety without major adverse events.See study design

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects may include typical risks associated with physical activity such as muscle soreness or strain. The presence of a support person suggests precautions against falls or other emergencies during exercise.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am an adult scheduled for heart surgery, including bypass or valve repair/replacement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ completed at baseline and end of week 3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~completed at baseline and end of week 3

This trial's timeline: 3 weeks for screening, Varies for treatment, and completed at baseline and end of week 3 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Adverse events related to exercise

Change in Euro-qol 5 Question-5 Dimension -5 Level (EQ-5D-5L)

Education

+3 more

Secondary outcome measures

Change in Duke Activity Status Index baseline to week 3

Change in Short Physical Performance Battery baseline to week 3

Trial Design

1Treatment groups

Experimental Treatment

Group I: Prehabilitation groupExperimental Treatment1 Intervention

Participants will engage in 4 virtual sessions with a physiotherapist, over a 3 week period. They will be prescribed an individual exercise program (based on assessment). Participants will complete the program 3x/week independently and diarize the exercise on provided documents. For participants living within Winnipeg, they will also diarize their accelerometer use/sleeping times during wear.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prehabilitation

2013

Completed Phase 3

~1040

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dr. Todd A DuhamelLead Sponsor

Kelly Codispodi, BMR PTPrincipal InvestigatorUniversity of Manitoba

Rakesh Aroroa, MDStudy DirectorUniversity of Manitoba

Frequently Asked Questions

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

What is the enrollment number for this research endeavor?

"Affirmative, the details available on clinicaltrials.gov verifies that this study is currently recruiting participants. It was first posted in July 18th 2023 and last updated on October 27th 2023. There are a total of 20 individuals needed for testing at 1 site only."

Answered by AI

Are there any available openings for participants in this clinical trial?

"According to clinicaltrials.gov, this experiment is currently enrolling participants. It was published on July 18th 2023 and the latest update was October 27th 2023."

Answered by AI

Recent research and studies

American Journal of Preventive MedicineJournal

How We Design Feasibility Studies

Bowen, Deborah J., Matthew Kreuter, Bonnie Spring, Ludmila Cofta-Woerpel, Laura Linnan, Diane Weiner, Suzanne Bakken, et al.. 2009. “How We Design Feasibility Studies”. American Journal of Preventive Medicine. Elsevier BV. doi:10.1016/j.amepre.2009.02.002.

clinicaltrials.govStudy

Home-based Exercise for Frail Individuals Prior to Cardiac Surgery

Dr. Todd A Duhamel 2023. "Home-based Exercise for Frail Individuals Prior to Cardiac Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05834556.