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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 60 Years and 99 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
This single arm pilot study will recruit 30 patients aged ≥60 years with persistent AF and HFpEF for a 4-month PREACTIVE intervention. Participants will complete 16 weeks of exercise (3 sessions per week) with a study exercise interventionist (trainer). PREACTIVE comprises of two phases, each lasting 2 months (8 weeks, 3 sessions/week; 24 sessions total). Phase I employs progressive resistance training (PRT)-only to promote gains in muscle mass and strength, and neuromuscular function. Phase II includes 8 weeks (3 sessions/week; 24 sessions total) that will continue with an abbreviated version of PRT while focusing on aerobic endurance training. Aerobic training will gradually progress by workload and the heart rate reserve (HRR) method will be used to guide exercise intensity. The HRR is determined from the 6-minute walk test (6MWT) performed at the baseline visit and rate of perceived exertion (RPE) will be used to guide intensity and progression.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
PREACTIVE 		During Phase I participants will engage first in progressive resistance training only (3 sessions/week; 24 sessions total) to optimize gains in muscle mass and strength, neuromuscular function, and hemodynamic gains. Phase II includes 8 weeks that focus on aerobic endurance training and also an abbreviated version of PRT (3 sessions/week; 24 sessions total).
  • 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.

Recruiting Locations

Northwestern University
Chicago, Illinois 60611

More Details

Status
Recruiting
Sponsor
Northwestern University

Study Contact

Mandy Pershing, MS
312-503-3237
mandy.pershing@northwestern.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.