Cardiovascular Prehabilitation in Patients Awaiting Heart Transplantation (PREHAB HTx Study)

Heart Failure Clinical Trial

— PREHAB  

Official title:

Cardiovascular Prehabilitation in Patients Awaiting Heart Transplantation - Addressing Clinical Needs (PREHAB HTx Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02957955
• Other study ID #: 20160753-01H
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: February 2, 2020

Study information

• Verified date: April 2021
• Source: Ottawa Heart Institute Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the addition of high-intensity interval training to the standard pre-heart transplantation clinical care. Participants will be randomised into 2 arms: one arm will receive high-intensity interval training, and the other arm will be encouraged to remain physically active, although they do not participate in a regular structured exercise training program.

Description:

Heart failure affects more than 6.2 million people living in North America. Approximately 10% of patients with heart failure have advanced heart failure. Heart transplantation is an effective life-saving treatment for patients with advanced heart failure. The cardiovascular rehabilitation programs are integral to heart failure management.

This study is being done to evaluate, in adults with advanced heart failure awaiting heart transplantation, the effects of cardiovascular rehabilitation (including high-intensity interval training, stress management and nutrition workshops) on functional capacity, aerobic power, frailty, quality of life, and mental health.

This study compares pre-transplant cardiovascular rehabilitation with usual pre-transplant care in patients with advanced heart failure awaiting heart transplant.

All participants will be randomized into 2 study groups: Group 1 (rehab), and Group 2 (no rehab). Those randomized to Group 1 will receive usual care, 12 weeks of rehab (exercise training, and attend stress and nutrition course through the Heart Failure Clinic and the Division of Prevention and Rehabilitation at the University of Ottawa Heart Institute). Those randomized to Group 2 will receive regular visits through the Heart Failure Clinic; patients are encouraged to remain physically active, although they do not participate in a regular structured exercise training program.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: February 2, 2020
• Est. primary completion date: February 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Advanced heart failure and listed for heart transplantation.

2. Able to perform a symptom-limited exercise test.

3. Age =>18 years old.

4. Able to provide informed consent.

Exclusion Criteria:

1. Currently participating in a structured exercise training program (> 2 times per week)

2. Status 4 priority listing for heart transplantation.

3. Myocardial infarction =<7 days.

4. Heart failure with hemodynamic instability.

5. Hypertrophic obstructive cardiomyopathy with symptomatic left ventricular outflow tract gradient =>30 mmHg.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Behavioral:
• High-Intensity Interval Training
Participants will complete supervised exercise sessions. Participants will attend on-site high-intensity interval training two times weekly for 12 weeks. Participants will complete six-minute walk test, cardiopulmonary exercise test, and six questionnaires: Short Form 36 Health Survey Questionnaire (SF-36), Minnesota Living with Heart Failure Questionnaire (MLHFQ), Beck Depression Inventory II (BDI-II), Beck Anxiety Inventory (BAI), Montreal Cognitive Assessment (MOCA), and Impact of Events Scale-Revised (IES-R) at baseline (week 1) and follow-up (after 12 weeks of intervention).

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in functional capacity	Change in in functional capacity from baseline to 12 weeks as measured by six-minute walk test distance. Distance walked will be measured in meters.	Baseline to 12 weeks
Secondary	Change in aerobic power	Measured using expired VO2 gas samples, measured in L/min, ml/kg/min	Baseline to 12 weeks
Secondary	Change in frailty	Measured by the Fried criteria. Measured by presence of 3 out of 5 frailty symptoms.	Baseline to 12 weeks
Secondary	Change in general quality of life	Measured by the Short Form 36 Health Survey Questionnaire (SF-36). The SF-36 consists of 8-scaled scores which are the weighted sums of the questions in their section.	Baseline to 12 weeks
Secondary	Change in disease-specific quality of life	Measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ). MLHFQ is a 21-item scale that measures the effects of heart failure on quality of life using a 6-point scale.	Baseline to 12 weeks
Secondary	Change in depressive symptoms	Measured by the Beck Depression Inventory II (BDI-II). It contains 21-questions, each answer being scored on a scale of 0 to 3.	Baseline to 12 weeks
Secondary	Change in anxiety	Measured by the Beck Anxiety Inventory (BAI). The BAI is a 21-item validated self-reported measure. A total score is calculated by summing the items; maximum score is 62.	Baseline to 12 weeks
Secondary	Change in cognitive function	Measured by the Montreal Cognitive Assessment (MOCA). The MOCA is made up of 8 subscales, scores are totaled; maximum score is 30 points.	Baseline to 12 weeks
Secondary	Change in response to a specific traumatic event	Measured by the Impact of Events Scale- Revised (IES-R). IES-R is 22 items, zero to four scale. Scores above 23 are of concern; scores above 32 indicate a probable diagnosis of PTSD.	Baseline to 12 weeks
Secondary	Short term post-heart transplantation outcomes	Data collected from medical records: length of hospital stay, adverse events (infection, treated rejection, bleeding, and stroke), survival to hospital discharge, and 30 day hospital readmissions.	One year post-heart transplantation