NCT07324772 · Northwestern University
PREACTIVE: Preconditioning Exercise Intervention to Improve Symptoms and Quality of Life in Comorbid Atrial Fibrillation and HFpEF
(PREACTIVE)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
progressive resistance training
2 months of progressive resistance training, performed for 3 sessions/week; 24 sessions total, under supervision with a trainer (1:1 interaction) Sessions include six upper- and lower-extremity exercises performed in alternate pattern as described (e.g., chest press, seated leg press, seated latissimus pull-down, knee/leg extension, shoulder press, leg curls) using pressurized or weighted machines. Participants will start the intensity of 40-50% of their baseline 1 repetition maximum (1-RM), with the goal of progressing to 70-80% of their 1-RM by 8 weeks, if able. Progression in intensity and reps will follow the principles of overload, such that resistance will be incremented only when a subject completes 12 reps for at least 2 of the 3 total sets at a given resistance, complemented by a reduction in the number of reps per set.
BEHAVIORAL
combined aerobic + resistance training
Phase II comprises of 8 weeks of aerobic training (primary focus) while continuing a shortened PRT protocol comprising of 3-4 exercises targeting upper and lower body. Sessions will be 3 sessions/week; 24 sessions total). Initial training intensity will be 40-50% of the HRR from the 6MWT with the goal of progressing to 60%-70% of HRR and for 20-35min over 8 weeks. Goals will be adjusted to 40%-50% HRR and 15-30min of exercise for those unable to meet targets.
Primary outcome measures
6 minute walk test (4 month change)
Time frame: change from baseline visit to 4 months (post intervention visit)
Submaximal aerobic capacity by the 6-minute walk test \[6MWT\]
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- All participants will be age 60 and older, have a primary diagnosis of AF and HFpEF, based on electronic health record review. Patients with persistent AF or Paroxysmal AF are eligible. HFpEF will be defined in accordance to the 2022 AHA/ACC/HFSA Guideline using a clinical composite score, the H2FPEF score, in conjunction with diagnostic criteria below:
- Ejection fraction ≥ 50%
- E/e' ≥15 by Doppler Echocardiography
- High H2FpEF score (≥5)
- Must be in stable medical condition and able to begin an exercise program
Exclusion criteria
- Valvular heart disease as the primary etiology of heart failure (i.e., severe aortic stenosis or mitral regurgitation),
- New York Heart Association Stage IV
- Recent stroke (\<1 year)
- Evidence or History of Cardiac amyloidosis
- Patients with persistent AF and poor rate control (HR \> 110 at rest)
- Significant change in cardiac medication or Heart Failure symptoms \< 2 weeks
- Unstable or severe angina not controlled during daily activity by pharmacological therapy or at \<4 METS activity
- Uncontrolled hypertension (defined as systolic blood pressure \>200 mm Hg and/or diastolic blood pressure\>110 mm Hg) with medications
- Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
- Hospitalization or urgent care visit \< 4 weeks
- Oxygen dependent Chronic Obstructive Pulmonary Disease (COPD)
- Significant anemia (\<10 g/dL Hgb)
- End stage renal replacement therapy associated with the need for dialysis
- Active treatment for cancer defined as current radiation, chemotherapy, immunotherapy, or cancer recurrence within past 5 years
- Hospice care and indication of life expectancy less than 2 years
- Complete dependence confinement to a Wheelchair confinement or requiring a visual impairment or Orthopedic or severe musculoskeletal conditions that would prohibit resistance training or aerobic exercise.
- Physician diagnosed Alzheimer's disease or Dementia or bipolar or psychotic disorder; Montreal Cognitive Assessment (MoCA) is ≤ 18 (based on participant screening)
- High levels of physical functioning based the composite short physical performance battery score of ≥10 (out of 12)
- Planned major surgery, coronary or leg revascularization during the next six months
- Participation in a supervised exercise program or already engaging in regular exercise
- Plans to transfer care outside of NU within the study period
- Unable to consent or commit to requires study procedures
- Non-English speaking
Where
- Chicago, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 24, 2026 · Source of record for eligibility and locations