Exercise Program for Atrial Fibrillation and Heart Failure

(PREACTIVE Trial)

MP
Overseen ByMandy Pershing, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Northwestern University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Atrial fibrillation (AF) and heart failure with preserved ejection fraction (HFpEF) are very common conditions that often occur together and result in worsening symptoms and reduced quality of life (QoL). Limitations being able to participate in activities of daily living is a primary complaint for AF-HFpEF patients, yet effective strategies to address this issue remain limited. While exercise interventions targeting aerobic training (AT) are recommended for patients with AF and HFpEF, unique challenges exist in this patient population who tend to be older. Specifically, many older patients with AF and HFpEF have muscle weakness, sarcopenia and frailty, that can make aerobic-focused exercise difficult and less tolerable. This study proposes that starting with progressive resistance training (PRT) before aerobic exercise may overcome these issues by improving muscle strength, making AT more manageable, and leading to better health outcomes. The goal of this study is to assess whether a sequential exercise program, named 'PREACTIVE' improves how people feel, decrease the amount of symptoms, and their ability to participate in exercise and activities.

This study will specifically test a sequenced exercise approach of resistance training followed by aerobic exercise to improve symptoms, and quality of life in AF-HFpEF.

Who Is on the Research Team?

DL

Deepika Laddu, PhD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for older adults with atrial fibrillation and heart failure who have a normal or near-normal ejection fraction, signs of high left ventricular filling pressures on an echocardiogram, and a high risk score for heart failure. Participants should be medically stable and capable of starting an exercise program.

Inclusion Criteria

I am medically stable and can start exercising.
Ejection fraction must be ≥ 50%
I am 60 years old or older.
See 5 more

Exclusion Criteria

I cannot consent or commit to the study's required procedures.
My heart condition severely limits my physical activity.
I have been diagnosed with or have a history of cardiac amyloidosis.
See 20 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I: Progressive Resistance Training

Participants engage in progressive resistance training to optimize gains in muscle mass and strength, neuromuscular function, and hemodynamic gains

8 weeks
3 sessions per week, 24 sessions total

Phase II: Aerobic Endurance Training

Participants focus on aerobic endurance training and an abbreviated version of progressive resistance training

8 weeks
3 sessions per week, 24 sessions total

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • PREACTIVE

Trial Overview

The PREACTIVE study tests whether beginning with progressive resistance training (strength exercises) before moving to aerobic activities (like walking or cycling) can improve symptoms, quality of life, muscle strength, and the ability to engage in daily activities for those with AF-HFpEF.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: PREACTIVEExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+