Progressive Resistance Training First to Help AF and HFpEF Patients Feel Better

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults 60 years and older with atrial fibrillation and heart failure with preserved ejection fraction participate in a pilot program that begins with progressive resistance training and then adds aerobic exercise. The study measures aerobic capacity as the primary outcome and also looks at muscle strength, physical function, AF-related symptoms, and quality of life. The goal is to see if this sequencing improves tolerability and overall health compared with usual approaches. The trial is conducted at Northwestern University in Chicago, sponsored by Northwestern University, with a focus on feasibility and preliminary efficacy. Eligible participants have stable medical status and no major exclusions such as recent stroke or severe valvular disease.

Why it matters

Who can join: the full rules

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 it's running

• Northwestern University
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Deepika Laddu, PhD — Northwestern University
• Study coordinator: Mandy Pershing, MS
• Email: mandy.pershing@northwestern.edu
• Phone: 312-503-3237

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.