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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-99
SponsorNorthwestern University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • progressive resistance training

    Behavioral

    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.

  • combined aerobic + resistance training

    Behavioral

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: PREACTIVEExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

6 minute walk test (4 month change)

Submaximal aerobic capacity by the 6-minute walk test \[6MWT\]

Time frame
change from baseline visit to 4 months (post intervention visit)

Secondary outcomes

1

muscle strength

change in muscle strength assessed by 1-repetition maximum (or equivalent) for chest press and leg press

Time frame
change from baseline visit to 4 months (post-intervention visit)
2

short physical performance battery

Physical function short physical performance battery

Time frame
change from baseline to 4 months (post intervention visit)
3

Atrial Fibrillation symptom severity by the Atrial Fibrillation Severity Scale (AFSS)

Atrial Fibrillation symptom severity by the Atrial Fibrillation Severity Scale (AFSS)

Time frame
change from baseline to 4 months (post-intervention visit)
4

Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire

Afib specific quality of life

Time frame
change from baseline to 4 months (post intervention visit)

Other outcomes

Sponsors and contacts

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