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PREACTIVE: Preconditioning Exercise Intervention to Improve Symptoms and Quality of Life in Comorbid Atrial Fibrillation and HFpEF

NCT07324772 · Northwestern University
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Official title
PREACTIVE: Preconditioning With REsistance and AerobiC Training to ImproVe Exercise Intolerance and Quality of Life in Comorbid Atrial Fibrillation and HFpEF
About this study
The main objective of this research to evaluate the feasibility and preliminary efficacy of a pilot exercise training program ('PREACTIVE') sequenced specifically for optimal function in AF-HFpEF on aerobic capacity (primary outcome), and its relation to secondary measures-muscle strength, physical function, AF symptom burden and QoL.
Eligibility criteria
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
Study design
Enrollment target: 30 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-05-15
Estimated completion: 2027-05
Last updated: 2026-08-24
Interventions
Behavioral: progressive resistance trainingBehavioral: combined aerobic + resistance training
Primary outcomes
  • 6 minute walk test (4 month change) (change from baseline visit to 4 months (post intervention visit))
Sponsor
Northwestern University · other
Contacts & investigators
ContactMandy Pershing, MS · contact · mandy.pershing@northwestern.edu · 312-503-3237
InvestigatorDeepika Laddu, PhD · principal_investigator, Northwestern University
All locations (1)
Northwestern UniversityRecruiting
Chicago, Illinois, United States