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| ID | Type | Description | Link |
|---|---|---|---|
| 00000132 | Other Identifier | National Institute on Aging | |
| P30AG021332 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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 Supervised exercise training (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 Heart failure with preserved ejection fraction (HFpEF) and assign to 2 sequential groups/waves for trainer-guided, aerobic-based exercise and group counseling sessions, with iterative refinements between waves.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| multi-domain behavioral, coaching, and exercise protocol | Experimental | A non-randomized, single-arm, iterative refinement pilot study. The study will recruit older patients with Heart Failure with Preserved Ejection Fraction (HFpEF) and assign them to 2 sequential groups/waves for trainer-guided, aerobic-based exercise and group counseling sessions, with iterative refinements between waves. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multi-domain behavioral, coaching, and exercise protocol | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Week 12 |
| Exercise Benefits/Barriers Scale Score | Evaluates how participants determine benefits of and barriers to participating in exercise. | Baseline |
| Exercise Benefits/Barriers Scale Score | Evaluates how participants determine benefits of and barriers to participating in exercise. | Week 4 |
| Exercise Benefits/Barriers Scale Score | Evaluates how participants determine benefits of and barriers to participating in exercise. | Week 12 |
| Heart Failure quality-of-life assessment - Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anthony E Peters, MD | Contact | 336-713-2278 | Anthony.Peters@advocatehealth.org | |
| Kimberly Kennedy, MS | Contact | 336.713.8567 | Kimberly.Kennedy@Advocatehealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Anthony E Peters, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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older patients with Heart Failure with Preserved Ejection Fraction (HFpEF) will be assigned to 2 sequential groups/waves for trainer-guided, aerobic-based exercise and group counseling sessions, with iterative refinements between waves.
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scores from 0-100, where higher scores indicate better health
| Baseline |
| Heart Failure quality-of-life assessment - Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores | scores from 0-100, where higher scores indicate better health | Week 4 |
| Heart Failure quality-of-life assessment - Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores | scores from 0-100, where higher scores indicate better health | Week 12 |
| Number of daily steps by accelerometer | Number of daily steps recorded for 1 week | Baseline |
| Number of daily steps by accelerometer | Number of daily steps recorded for 1 week | Week 4 |
| Number of daily steps by accelerometer | Number of daily steps recorded for 1 week | 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. | 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. | 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. | 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). | 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). | 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). | 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. | 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. | 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. | 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. | 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. | Week 12 |