Heart failure with preserved ejection fraction (HFpEF) represents a major public health burden that is both growing rapidly and has few effective therapies. Supervised exercise training (SET) is one of the few effective therapies for older patients with HFpEF, but is currently constrained by cost, resource limitations, and sub-optimal short and long-term clinical response. The objective is to develop and test novel strategies to augment the therapy of exercise training to optimize response and resource utilization in older patients with HFpEF.
The hypothesis is that enhancing SET with a group-mediated behavioral approach and remote activity-monitoring will enable more robust behavioral changes in physical activity at lower cost. To test this hypothesis, the study will recruit patients with HFpEF and assign to 2 sequential groups/waves for trainer-guided, aerobic-based exercise and group counseling sessions, with iterative refinements between waves.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
14
Group-mediated educational sessions, individual coaching contacts, group exercise sessions, and home-based self-guided exercise - Groups will engage in this iterative, trainer-guided, in-person, aerobic-based exercise and group counseling sessions approximately 2 times/week for 12 weeks.
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Exercise self-efficacy scales Scores
Total score is calculated by summing the responses to each question. This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise.
Time frame: Baseline
Exercise self-efficacy scales Scores
Total score is calculated by summing the responses to each question. This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise.
Time frame: Week 4
Exercise self-efficacy scales Scores
Total score is calculated by summing the responses to each question. This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise.
Time frame: Week 12
Exercise Benefits/Barriers Scale Score
Evaluates how participants determine benefits of and barriers to participating in exercise.
Time frame: Baseline
Exercise Benefits/Barriers Scale Score
Evaluates how participants determine benefits of and barriers to participating in exercise.
Time frame: Week 4
Exercise Benefits/Barriers Scale Score
Evaluates how participants determine benefits of and barriers to participating in exercise.
Time frame: Week 12
Heart Failure quality-of-life assessment - Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores
scores from 0-100, where higher scores indicate better health
Time frame: Baseline
Heart Failure quality-of-life assessment - Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores
scores from 0-100, where higher scores indicate better health
Time frame: Week 4
Heart Failure quality-of-life assessment - Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores
scores from 0-100, where higher scores indicate better health
Time frame: Week 12
Number of daily steps by accelerometer
Number of daily steps recorded for 1 week
Time frame: Baseline
Number of daily steps by accelerometer
Number of daily steps recorded for 1 week
Time frame: Week 4
Number of daily steps by accelerometer
Number of daily steps recorded for 1 week
Time frame: Week 12
6-minute walk distance
measures functional capacity by the distance walked in 6 minutes, indicating disease severity, prognosis, and treatment response, especially in cardiopulmonary conditions like COPD or heart failure shorter distances (e.g., \<350m) often signaling higher mortality risk, while significant changes (e.g., \>50m) suggest clinical improvement or decline, though interpretation always needs clinical context and comparison to age/gender norms.
Time frame: Baseline
6-minute walk distance
measures functional capacity by the distance walked in 6 minutes, indicating disease severity, prognosis, and treatment response, especially in cardiopulmonary conditions like COPD or heart failure shorter distances (e.g., \<350m) often signaling higher mortality risk, while significant changes (e.g., \>50m) suggest clinical improvement or decline, though interpretation always needs clinical context and comparison to age/gender norms.
Time frame: Week 4
6-minute walk distance
measures functional capacity by the distance walked in 6 minutes, indicating disease severity, prognosis, and treatment response, especially in cardiopulmonary conditions like COPD or heart failure shorter distances (e.g., \<350m) often signaling higher mortality risk, while significant changes (e.g., \>50m) suggest clinical improvement or decline, though interpretation always needs clinical context and comparison to age/gender norms.
Time frame: Week 12
The Short Physical Performance Battery (SPPB) Score
The SPPB is a measure of physical function that incorporates three components: usual gait speed measured over 4 meters, timed repeated chair rise, and standing balance with progressively narrow base of support. Each component is scored on a 0-4 scale and then summed to provide an overall score range of 0-12 - scores ranging from 0 (worst) to 12 (best).
Time frame: Baseline
The Short Physical Performance Battery (SPPB) Score
The SPPB is a measure of physical function that incorporates three components: usual gait speed measured over 4 meters, timed repeated chair rise, and standing balance with progressively narrow base of support. Each component is scored on a 0-4 scale and then summed to provide an overall score range of 0-12 - scores ranging from 0 (worst) to 12 (best).
Time frame: Week 4
The Short Physical Performance Battery (SPPB) Score
The SPPB is a measure of physical function that incorporates three components: usual gait speed measured over 4 meters, timed repeated chair rise, and standing balance with progressively narrow base of support. Each component is scored on a 0-4 scale and then summed to provide an overall score range of 0-12 - scores ranging from 0 (worst) to 12 (best).
Time frame: Week 12
Grip strength
Low handgrip strength, a key indicator in sarcopenia, is often defined as \<28 kg for men and \<18 kg for women (based on AWGS19) or even lower, depending on the study, such as \<26 kg and \<16 kg.
Time frame: Baseline
Grip strength
Low handgrip strength, a key indicator in sarcopenia, is often defined as \<28 kg for men and \<18 kg for women (based on AWGS19) or even lower, depending on the study, such as \<26 kg and \<16 kg.
Time frame: Week 4
Grip strength
Low handgrip strength, a key indicator in sarcopenia, is often defined as \<28 kg for men and \<18 kg for women (based on AWGS19) or even lower, depending on the study, such as \<26 kg and \<16 kg.
Time frame: Week 12
Cardiopulmonary Exercise Testing (CPET)
Evaluates how your heart, lungs, and muscles work together during physical exertion, using a treadmill or bike while monitoring breathing (mask), heart activity (ECG), and vitals (blood pressure) to diagnose causes of shortness of breath, assess heart/lung conditions like heart failure or Chronic Obstructive Pulmonary Disease (COPD), and determine exercise capacity, offering a comprehensive view of cardiovascular and respiratory fitness. Normal values typically range from 35 to 40 mL/kg/min for healthy middle-aged individuals, with variations based on age, sex, and training status.
Time frame: Baseline
Cardiopulmonary Exercise Testing (CPET)
Evaluates how your heart, lungs, and muscles work together during physical exertion, using a treadmill or bike while monitoring breathing (mask), heart activity (ECG), and vitals (blood pressure) to diagnose causes of shortness of breath, assess heart/lung conditions like heart failure or Chronic Obstructive Pulmonary Disease (COPD), and determine exercise capacity, offering a comprehensive view of cardiovascular and respiratory fitness. Normal values typically range from 35 to 40 mL/kg/min for healthy middle-aged individuals, with variations based on age, sex, and training status.
Time frame: Week 12
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