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

Official title

PREACTIVE: Preconditioning With REsistance and AerobiC Training to ImproVe Exercise Intolerance and Quality of Life in Comorbid Atrial Fibrillation and HFpEF

Overview

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.

Detailed description

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.

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), wit
• 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)]

Secondary outcome measures (5)

• muscle strength [Time frame: change from baseline visit to 4 months (post-intervention visit)]
• short physical performance battery [Time frame: change from baseline to 4 months (post intervention visit)]
• Atrial Fibrillation symptom severity by the Atrial Fibrillation Severity Scale (AFSS) [Time frame: change from baseline to 4 months (post-intervention visit)]
• Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire [Time frame: change from baseline to 4 months (post intervention visit)]
• Kansas City Cardiomyopathy Questionnaire [Time frame: change from baseline to 4 months (post intervention visit)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Northwestern University — Chicago

Identifiers

NCT: NCT07324772 · STU#: 00223545

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗