PREACTIVE: Preconditioning With REsistance and AerobiC Training to ImproVe Exercise Intolerance and Quality of Life in Comorbid Atrial Fibrillation and HFpEF
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Northwestern University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- 6 minute walk test (4 month change)
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to 99 Years (Adult, Older Adult)
- 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
Arms & Interventions
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).
Intervention: progressive resistance training (Behavioral)
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).
Intervention: combined aerobic + resistance training (Behavioral)
Outcomes
Primary Outcomes
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 \[6MWT\]
Secondary Outcomes
- muscle strength(change from baseline visit to 4 months (post-intervention visit))
- short physical performance battery(change from baseline to 4 months (post intervention visit))
- Atrial Fibrillation symptom severity by the Atrial Fibrillation Severity Scale (AFSS)(change from baseline to 4 months (post-intervention visit))
- Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire(change from baseline to 4 months (post intervention visit))
- Kansas City Cardiomyopathy Questionnaire(change from baseline to 4 months (post intervention visit))
Investigators
Deepika Laddu
PI, Associate Professor
Northwestern University