Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R37AG018915 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to examine the effects of weight loss via hypocaloric diet, aerobic exercise training, combined hypocaloric diet and exercise training, and attention control in patients with heart failure and a normal ejection fraction (HFNEF) and body mass index greater than or equal to 30.
Heart failure with a normal ejection fraction (HFNEF, previously termed diastolic heart failure), accounts for the majority of heart failure cases in the population > 65 years old and has been recognized as a true geriatric syndrome. Exercise intolerance is the primary chronic symptom of HFNEF and a major determinant of these patients' severely reduced quality of life; however little is known regarding its pathophysiology and treatment. Therefore, our work has focused on understanding the pathophysiology of exercise intolerance in HFNEF and developing and testing interventions that may improve this pivotal outcome in this highly prevalent disorder of older persons. The aims of the proposed study are to conduct a randomized, controlled, single-blinded, 2x2 design trial to examine the effects of weight loss via hypocaloric diet, aerobic exercise training, combined hypocaloric diet and exercise training, and attention control in patients with HFNEF and body mass index >30 in order to test the following hypotheses: 1) Both weight loss and exercise training will improve exercise intolerance and quality of life in older, obese patients with HFNEF; 2) The combination of weight loss and exercise training will produce complementary effects on body and thigh muscle composition and additive improvements in exercise intolerance in HFNEF; 3) Improvements in exercise intolerance will correlate with improvements in lean body mass, reversal of adverse thigh muscle remodeling, and increased thigh muscle capillarity. The study has the potential to significantly advance our understanding of exercise intolerance and its treatment in the large population of older persons with HFNEF.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Training | Active Comparator | Exercise participants will undergo a 1-hour supervised exercise program 3 times per week for 20 weeks consisting primarily of walking exercise using an individualized exercise prescription based on the initial exercise stress testing results. |
|
| Dietary Intervention | Active Comparator | A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb) weight loss per week. |
|
| Attention control | Active Comparator | Attention control participants will be provided a counseling session regarding general health education at baseline and will be contacted by staff via telephone every 2 weeks to discuss general health status. |
|
| Diet and Exercise | Active Comparator | A hypocaloric diet will be developed to achieve a 2450 kcal/week deficit in addition to undergoing a 1-hour supervised exercise program 3 times per week for 20 weeks consisting primarily of walking exercise using an individualized exercise prescription based on the initial exercise stress testing results. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | walking, treadmill and bicycle exercise |
|
| Measure | Description | Time Frame |
|---|---|---|
| Exercise Capacity | Exercise capacity assessed as Peak VO2 (ml/kg/min) via treadmill cardiopulmonary exercise testing using the modified Naughton protocol to the end point of exhaustion. | 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | Heart failure-specific quality of life was assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ) on a range 0-100; higher scores indicate better quality of life. | 20 weeks |
| Body Composition |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dalane W Kitzman, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 271757 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34774747 | Derived | Singleton MJ, Nelson MB, Samuel TJ, Kitzman DW, Brubaker P, Haykowsky MJ, Upadhya B, Chen H, Nelson MD. Left Atrial Stiffness Index Independently Predicts Exercise Intolerance and Quality of Life in Older, Obese Patients With Heart Failure With Preserved Ejection Fraction. J Card Fail. 2022 Apr;28(4):567-575. doi: 10.1016/j.cardfail.2021.10.010. Epub 2021 Nov 10. | |
| 34344169 | Derived | Anderson T, Cascino TM, Koelling TM, Perry D, Grafton G, Houston DK, Upadhya B, Kitzman DW, Hummel SL. Measured Versus Estimated Resting Metabolic Rate in Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2021 Aug;14(8):e007962. doi: 10.1161/CIRCHEARTFAILURE.120.007962. Epub 2021 Aug 4. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Exercise Training | Based on initial evaluations and the stress testing results, (HR(heart rate), VO2(maximal volume of oxygen that the body can deliver to the working muscles per minute), RPE(rate perceived exertion) an individualized exercise prescription will be developed for each subject. Exercise: walking, treadmill and bicycle exercise |
| FG001 | Dietary Intervention | A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb) weight loss per week. Dietary Intervention: Subjects will be provided meals and instructions for individual food selections. |
| FG002 | Attention Control | Attention control participants will be provided a counseling session regarding general health education at baseline and will be contacted by staff via telephone every 2 weeks to discuss general health status. Attention Control: control group- continue their previously randomized life style |
| FG003 | Diet and Exercise | The diet and exercise group is a combination of the two groups previously described. Exercise: walking, treadmill and bicycle exercise Diet and exercise: Combination of the exercise and diet group as previously described. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Exercise Training | Based on initial evaluations and the stress testing results, (HR(heart rate), VO2(maximal volume of oxygen that the body can deliver to the working muscles per minute), RPE(rate perceived exertion) an individualized exercise prescription will be developed for each subject. Exercise: walking, treadmill and bicycle exercise |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Exercise Capacity | Exercise capacity assessed as Peak VO2 (ml/kg/min) via treadmill cardiopulmonary exercise testing using the modified Naughton protocol to the end point of exhaustion. | Posted | Mean | 95% Confidence Interval | ml/kg/min | 20 weeks |
|
20 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exercise Training | Based on initial evaluations and the stress testing results, (HR(heart rate), VO2(maximal volume of oxygen that the body can deliver to the working muscles per minute), RPE(rate perceived exertion) an individualized exercise prescription will be developed for each subject. Exercise: walking, treadmill and bicycle exercise |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart failure exacerbation | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia | Endocrine disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dalane W. Kitzman, M.D. | Wake Forest School of Medicine | 336-716-3274 | dkitzman@wakehealth.edu |
Not provided
| ID | Term |
|---|---|
| D054144 | Heart Failure, Diastolic |
| D009765 | Obesity |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
Not provided
Not provided
| ID | Term |
|---|---|
| D015444 | Exercise |
| D004035 | Diet Therapy |
| D004032 | Diet |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Dietary Intervention | Dietary Supplement | Subjects will be provided meals and instructions for individual food selections. |
|
| Diet and exercise | Behavioral | Subjects will be provided meals and instructions for individual food selections and will undergo walking, treadmill and bicycle exercise. |
|
| Attention Control | Other | control group- continue their previously randomized life style |
|
Total Body Fat Mass and Total Non-bone Lean Mass via DEXA
| 20 weeks |
| Thigh Muscle Composition | Thigh Skeletal Muscle and Subcutaneous Fat via MRI | 20 weeks |
| 30007558 | Derived | Haykowsky MJ, Nicklas BJ, Brubaker PH, Hundley WG, Brinkley TE, Upadhya B, Becton JT, Nelson MD, Chen H, Kitzman DW. Regional Adipose Distribution and its Relationship to Exercise Intolerance in Older Obese Patients Who Have Heart Failure With Preserved Ejection Fraction. JACC Heart Fail. 2018 Aug;6(8):640-649. doi: 10.1016/j.jchf.2018.06.002. Epub 2018 Jul 11. |
| 27693420 | Derived | Maldonado-Martin S, Brubaker PH, Eggebeen J, Stewart KP, Kitzman DW. Association Between 6-Minute Walk Test Distance and Objective Variables of Functional Capacity After Exercise Training in Elderly Heart Failure Patients With Preserved Ejection Fraction: A Randomized Exercise Trial. Arch Phys Med Rehabil. 2017 Mar;98(3):600-603. doi: 10.1016/j.apmr.2016.08.481. Epub 2016 Sep 28. |
| 26746456 | Derived | Kitzman DW, Brubaker P, Morgan T, Haykowsky M, Hundley G, Kraus WE, Eggebeen J, Nicklas BJ. Effect of Caloric Restriction or Aerobic Exercise Training on Peak Oxygen Consumption and Quality of Life in Obese Older Patients With Heart Failure With Preserved Ejection Fraction: A Randomized Clinical Trial. JAMA. 2016 Jan 5;315(1):36-46. doi: 10.1001/jama.2015.17346. |
| BG001 |
| Dietary Intervention |
A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb) weight loss per week. Dietary Intervention: Subjects will be provided meals and instructions for individual food selections. |
| BG002 | Attention Control | Attention control participants will be provided a counseling session regarding general health education at baseline and will be contacted by staff via telephone every 2 weeks to discuss general health status. Attention Control: control group- continue their previously randomized life style |
| BG003 | Diet and Exercise | The diet and exercise group is a combination of the two groups previously described. Exercise: walking, treadmill and bicycle exercise Diet and exercise: Combination of the exercise and diet group as previously described. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 | Attention Control | Attention control participants will be provided a counseling session regarding general health education at baseline and will be contacted by staff via telephone every 2 weeks to discuss general health status. Attention Control: control group- continue their previously randomized life style |
| OG003 | Diet and Exercise | The diet and exercise group is a combination of the two groups previously described. Exercise: walking, treadmill and bicycle exercise Diet and exercise: Combination of the exercise and diet group as previously described. |
|
|
|
| Secondary | Quality of Life | Heart failure-specific quality of life was assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ) on a range 0-100; higher scores indicate better quality of life. | Posted | Mean | 95% Confidence Interval | units on a scale | 20 weeks |
|
|
|
|
| Secondary | Body Composition | Total Body Fat Mass and Total Non-bone Lean Mass via DEXA | Posted | Mean | 95% Confidence Interval | kg | 20 weeks |
|
|
|
|
| Secondary | Thigh Muscle Composition | Thigh Skeletal Muscle and Subcutaneous Fat via MRI | Posted | Mean | 95% Confidence Interval | cm^2 | 20 weeks |
|
|
|
|
| 1 |
| 26 |
| 2 |
| 26 |
| EG001 | Dietary Intervention | A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb) weight loss per week. Dietary Intervention: Subjects will be provided meals and instructions for individual food selections. | 0 | 24 | 1 | 24 |
| EG002 | Attention Control | Attention control participants will be provided a counseling session regarding general health education at baseline and will be contacted by staff via telephone every 2 weeks to discuss general health status. Attention Control: control group- continue their previously randomized life style | 1 | 25 | 0 | 25 |
| EG003 | Diet and Exercise | The diet and exercise group is a combination of the two groups previously described. Exercise: walking, treadmill and bicycle exercise Diet and exercise: Combination of the exercise and diet group as previously described. | 1 | 25 | 2 | 25 |
| Pancreatitis | Endocrine disorders | Systematic Assessment |
|
| Leg edema | Blood and lymphatic system disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Stress fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Tendon tear | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
Not provided
Not provided
| D009748 |
| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| ANCOVA |
Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage. |
| 0.43 |
Main effects analysis for Exercise vs. No Exercise. |
| Superiority |
| Total Non-Bone Lean |
|
Total Body Fat Mass |
| ANCOVA |
Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage. |
| 0.001 |
Main effects analysis of Exercise vs. No Exercise. |
| Superiority |
| Total Non-Bone Lean Mass | ANCOVA | Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage. | <0.001 | Main effects analyses with Diet vs. No Diet. | Superiority |
| Total Non-Bone Lean Mass | ANCOVA | Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage. | 0.25 | Main effects analysis for Exercise vs. No Exercise. | Superiority |
| Thigh Skeletal Muscle |
|
Thigh Subcutaneous Fat |
| ANCOVA |
Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage. |
| 0.26 |
Main effects analysis for Exercise vs. No Exercise. |
| Superiority |
| Thigh Skeletal Muscle | ANCOVA | Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage. | <0.001 | Main effects analyses with Diet vs. No Diet. | Superiority |
| Thigh Skeletal Muscle | ANCOVA | Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage. | 0.26 | Main effects analysis of Exercise vs. No Exercise. | Superiority |