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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PREACTIVE | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 6 minute walk test (4 month change) | Submaximal aerobic capacity by the 6-minute walk test [6MWT] | change from baseline visit to 4 months (post intervention visit) |
| Measure | Description | Time Frame |
|---|---|---|
| muscle strength | change in muscle strength assessed by 1-repetition maximum (or equivalent) for chest press and leg press | change from baseline visit to 4 months (post-intervention visit) |
| short physical performance battery |
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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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mandy Pershing, MS | Contact | 312-503-3237 | mandy.pershing@northwestern.edu |
| Name | Affiliation | Role |
|---|---|---|
| Deepika Laddu, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
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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.
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|
| 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. |
|
Physical function short physical performance battery
| change from baseline to 4 months (post intervention visit) |
| Atrial Fibrillation symptom severity by the Atrial Fibrillation Severity Scale (AFSS) | 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 | Afib specific quality of life | change from baseline to 4 months (post intervention visit) |
| Kansas City Cardiomyopathy Questionnaire | overall (HF specific) health-related quality of life by the Kansas City Cardiomyopathy Questionnaire | change from baseline to 4 months (post intervention visit) |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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