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Virtual PREHAB for Cardiovascular Disease

N/A

Recruiting

Research Sponsored by Nova Scotia Health Authority

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Severe functional limitations

Cognitive impairment that impacts consenting ability

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-months postoperatively

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the effectiveness and safety of providing virtual preoperative cardiac rehabilitation (PREHAB) to frail patients before they undergo transcatheter aortic valve implantation (TAVI)

Who is the study for?

This trial is for outpatients in Nova Scotia who are frail and awaiting a less invasive heart valve surgery called TAVI. They must be able to give informed consent. It's not clear who can't join because the exclusion criteria aren't listed.

What is being tested?

The study tests if virtual PREHAB (preoperative cardiac rehabilitation) at home can improve health before TAVI, compared to standard care. Healthcare providers deliver this program virtually to see if it helps reduce frailty safely and feasibly.

What are the potential side effects?

Since the intervention involves non-invasive prehabilitation exercises and nutritional guidance delivered virtually, side effects may include typical exercise-related issues like muscle soreness or fatigue.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe difficulties performing daily activities.

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I can make decisions about my health care.

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My heart condition severely limits my physical activity.

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I don't have internet or phone access for virtual health programs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-months postoperatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-months postoperatively

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

CLSA-FI

PFFS-FI

Secondary study objectives

Cardiac rehabilitation attendance

EQ-5D-5L health-related quality of life

VARC-3 Composite clinical end-points

Awards & 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: Virtual PREHABExperimental Treatment1 Intervention

In addition to standard care, participants randomized to the The virtual PREHAB program will be delivered by the Hearts and Health in Motion cardiac rehabilitation CR health care team including a medical director nurse, dietician, and physiotherapist who routinely deliver CR postoperatively. The virtual PREHAB program will be up to 8-weeks in duration and deliver the core components of CR online or by telephone.

Group II: Standard CareActive Control1 Intervention

0 / 4Eligibility criteria met