Atrial Fibrillation (AF)PREACTIVENCT07324772
PREACTIVE: Preconditioning Exercise Intervention to Improve Symptoms and Quality of Life in Comorbid Atrial Fibrillation and HFpEF
A study testing progressive resistance training and combined aerobic + resistance training in people with Atrial Fibrillation (AF) and Atrial Fibrillation (Paroxysmal), run by Northwestern University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 to 99 years
- Conditions the study is for
- Atrial Fibrillation (AF), Atrial Fibrillation (Paroxysmal), Persistent Atrial Fibrillation
- What is being tested?
- progressive resistance training and combined aerobic + resistance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwestern University
Chicago, Illinois, 60611
About this study
Official title: PREACTIVE: Preconditioning With REsistance and AerobiC Training to ImproVe Exercise Intolerance and Quality of Life in Comorbid Atrial Fibrillation and HFpEF
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.
Read the 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.
- Conditions
- Atrial Fibrillation (AF), Atrial Fibrillation (Paroxysmal), Persistent Atrial Fibrillation, Heart Failure With Preserved Ejection Fraction (HFPEF)
- Being tested
- progressive resistance training, combined aerobic + resistance training
- Keywords
- exercise, exercise capacity, symptom severity, quality of life
- Medical subject headings
- Atrial Fibrillation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progressive resistance trainingBehavioural
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 trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: progressive resistance training; Behavioral: combined aerobic + resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute walk test (4 month change)
Submaximal aerobic capacity by the 6-minute walk test [6MWT]
Measured: change from baseline visit to 4 months (post intervention visit)
Secondary outcomes (5)
muscle strength
change in muscle strength assessed by 1-repetition maximum (or equivalent) for chest press and leg press
Measured: change from baseline visit to 4 months (post-intervention visit)
short physical performance battery
Physical function short physical performance battery
Measured: 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)
Measured: change from baseline to 4 months (post-intervention visit)
Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire
Afib specific quality of life
Measured: 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
Measured: change from baseline to 4 months (post intervention visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start15 May 2026
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deepika Laddu, Northwestern University
- Investigators
- Deepika Laddu, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324772
- Sponsor's protocol ID
- STU#: 00223545
- Acronym
- PREACTIVE
- Status last verified
- Aug 2026
- First submitted
- 24 Dec 2025
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREACTIVE: Preconditioning With REsistance and AerobiC Training to ImproVe Exercise Intolerance and Quality of Life in Comorbid Atrial Fibrillation and HFpEF
- ClinicalTrials.gov ID
- NCT07324772
- Acronym / sponsor ID
- PREACTIVE / STU#: 00223545
- Conditions
- Atrial Fibrillation (AF), Atrial Fibrillation (Paroxysmal), Persistent Atrial Fibrillation, Heart Failure With Preserved Ejection Fraction (HFPEF)
- Keywords
- exercise, exercise capacity, symptom severity, quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 15 May 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| PREACTIVE | Experimental | Behavioral: progressive resistance training, Behavioral: combined aerobic + resistance trainingDuring 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). |
Who may qualify
- Ages
- 60 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (23 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| progressive resistance training2 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. | Behavioural | PREACTIVE |
| combined aerobic + resistance trainingPhase 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. | Behavioural | PREACTIVE |
Primary outcome
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]
5 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Deepika Laddu, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing progressive resistance training and combined aerobic + resistance training in people with Atrial Fibrillation (AF) and Atrial Fibrillation (Paroxysmal), run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mandy Pershing, MS (312-503-3237, mandy.pershing@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 minute walk test (4 month change) (time frame: change from baseline visit to 4 months (post intervention visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.