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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG018915 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The purpose of this study is to examine the effects of weight loss via hypocaloric diet (CR)and aerobic exercise (AT) compared to the effects of weight loss via hypocaloric diet (CR), aerobic training (AT)and resistance training (RT).
Heart failure with preserved ejection fraction (HFPEF) is the most common form of HF, is nearly unique to the older population, particularly older women, and is increasing in prevalence. Exercise intolerance, with severe exertional dyspnea and fatigue, is the primary manifestation of chronic HFPEF and is a major determinant of these patients' severely reduced quality of life (QOL). However, its pathophysiology is poorly understood and its optimal treatment remains undefined.
Our recent data and others' indicate that in older HFPEF patients, both increased adiposity and abnormalities in skeletal muscle are major contributors to exercise intolerance and potential therapeutic targets. Obesity is one of the strongest risk factors for HFPEF, and is a robust predictor of physical disability in older persons. The investigator recently reported that in HFPEF compared to age-matched controls, percent total and leg lean mass are significantly reduced and independently predict exercise capacity.
Using MRI and needle biopsy of the thigh muscle, the investigators found increased fat infiltration, reduced capillary density and percent type I oxidative fibers, and trends for reduced muscle mitochondrial mass and function. Reduced exercise capacity was related to each of these muscle abnormalities, supporting their important role in HFPEF.
Diet, with or without aerobic exercise, can increase exercise capacity and quality of life in older obese persons with a variety of disorders, but usually results in significant loss of skeletal muscle mass, which could potentially have adverse long term consequences. The purpose of this trial is to determine if addition of resistance training to diet plus aerobic exercise training can improve skeletal muscle mass and function in HFPEF.
Multiple lines of evidence and our preliminary data indicate that resistance training (RT) may be an ideal addition to CR+AT for HFPEF, since RT reliably increases muscle mass, quality, strength, and function, significantly more than AT, and can prevent nearly 50% of the muscle mass loss during CR.
Therefore, the primary aim of the proposed study is to conduct a randomized, single-blinded 20-week intervention trial of RT added to CR+AT in 84 overweight / obese (BMI greater than 28 kg/m2), older (age greater than 60 years) HFPEF patients to test the following primary hypothesis:
The addition of resistance training to CR+AT will improve exercise capacity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dietary, and aerobic exercise | Active Comparator | Intervention for diet-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. Intervention for aerobic exercise-Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individual exercise prescription will be developed for aerobic training. |
|
| dietary, aerobic and resistance training | Active Comparator | Intervention for diet-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. Intervention for aerobic exercise-Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individual exercise prescription will be developed for aerobic training. Intervention for resistance training- Additional weight resistant exercise will be added to this arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dietary, aerobic and resistance training | Behavioral | hypocaloric diet individual exercise prescription for aerobic training individual exercise prescription for resistance training. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Exercise Oxygen Consumption (VO2) | Peak exercise oxygen consumption (VO2) pre and post intervention | 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Skeletal Muscle Mass | Measure skeletal muscle mass in kg by DEXA analysis pre and post intervention. | 20 weeks |
| Thigh Skeletal Muscle Mass | Measure skeletal muscle mass by MRI analysis pre and post intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Mitochondrial Content | Porin citrate synthase pre and post intervention. | 20 weeks |
| Mitochondrial Function | respiratory control ratio and mitofusin 2 concentration.pre and post intervention. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dalane W Kitzman, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38037817 | Derived | Schaich CL, Hughes TM, Kitzman DW, Jung Y, Chen H, Nicklas BJ, Houston DK, Brubaker PH, Molina AJA, Hugenschmidt CE. Neurocognitive Impairments and Their Improvement Following Exercise and Dietary Interventions in Older Patients With Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2024 Jan;17(1):e011134. doi: 10.1161/CIRCHEARTFAILURE.123.011134. Epub 2023 Dec 1. No abstract available. | |
| 36314122 | Derived | Brubaker PH, Nicklas BJ, Houston DK, Hundley WG, Chen H, Molina AJA, Lyles WM, Nelson B, Upadhya B, Newland R, Kitzman DW. A Randomized, Controlled Trial of Resistance Training Added to Caloric Restriction Plus Aerobic Exercise Training in Obese Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2023 Feb;16(2):e010161. doi: 10.1161/CIRCHEARTFAILURE.122.010161. Epub 2022 Oct 31. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dietary, and Aerobic Exercise | Intervention for diet-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. Intervention for aerobic exercise-Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individual exercise prescription will be developed for aerobic training. dietary, and aerobic exercise: hypocaloric diet individual prescription for aerobic training. |
| FG001 | Dietary, Aerobic, and Resistance Training | Intervention for diet-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. Intervention for aerobic exercise-Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individual exercise prescription will be developed for aerobic training. Intervention for resistance training- Additional weight resistant exercise will be added to this arm. dietary, aerobic and resistance training: hypocaloric diet individual exercise prescription for aerobic training individual exercise prescription for resistance training. dietary, and aerobic exercise: hypocaloric diet individual prescription for aerobic training. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dietary, and Aerobic Exercise | Intervention for diet-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. Intervention for aerobic exercise-Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individual exercise prescription will be developed for aerobic training. dietary, and aerobic exercise: hypocaloric diet individual prescription for aerobic training. |
| 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 | Peak Exercise Oxygen Consumption (VO2) | Peak exercise oxygen consumption (VO2) pre and post intervention | Analysis completed on all participants with peak VO2 obtained (n=77). | Posted | Least Squares Mean | Standard Error | ml/min | 20 weeks |
|
20 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dietary, and Aerobic Exercise | Intervention for diet-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. Intervention for aerobic exercise-Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individual exercise prescription will be developed for aerobic training. dietary, and aerobic exercise: hypocaloric diet individual prescription for aerobic training. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abscess | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dalane W. Kitzman, MD | Wake Forest School of Medicine | 336-716-3274 | dkitzman@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 2, 2022 | Jul 8, 2022 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 31, 2019 | Aug 27, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D054144 | Heart Failure, Diastolic |
| D009765 | Obesity |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
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| ID | Term |
|---|---|
| D004032 | Diet |
| D055070 | Resistance Training |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D005081 | Exercise Therapy |
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| dietary, and aerobic exercise | Behavioral | hypocaloric diet individual prescription for aerobic training. |
|
| 20 weeks |
| Thigh Muscle Composition | MRI skeletal muscle to intermuscular fat ratio | 20 weeks |
| Muscle Strength | maximal isokinetic knee extensor strength (Newton-meters, Nm) using an isokinetic dynamometer (Biodex®) | 20 weeks |
| Muscle Quality | knee extensor strength to thigh muscle area assessed by MRI (Nm/cm2). | 20 weeks |
| Quality of Life Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score | The KCCQ Overall Summary Summary Score is a heart failure disease-specific quality of life measure encompassing domains of physical limitation, HF symptoms, quality of life, and social limitation scored on a scale of 0-100 with higher scores indicating better health status. | 20 weeks |
| Quality of Life Measured by Short Form 36 Item Questionnaire (SF-36) | The SF-36 is a quality of life assessment with 2 component scores (Physical Composite Score and Mental Composite Score) ranging 0-100 with higher scores indicating better health status. | 20 weeks |
| 20 weeks |
| Non-compliance |
|
| Personal reasons |
|
| BG001 | Dietary, Aerobic and Resistance Training | Intervention for diet-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. Intervention for aerobic exercise-Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individual exercise prescription will be developed for aerobic training. Intervention for resistance training- Additional weight resistant exercise will be added to this arm. dietary, aerobic and resistance training: hypocaloric diet individual exercise prescription for aerobic training individual exercise prescription for resistance training. dietary, and aerobic exercise: hypocaloric diet individual prescription for aerobic training. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Peak exercise oxygen consumption (VO2) | Peak exercise oxygen consumption (VO2) assessed during cardiopulmonary exercise test using expired gas analysis. | Mean | Standard Deviation | ml/min |
|
Intervention for diet-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. Intervention for aerobic exercise-Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individual exercise prescription will be developed for aerobic training. Intervention for resistance training- Additional weight resistant exercise will be added to this arm. dietary, aerobic and resistance training: hypocaloric diet individual exercise prescription for aerobic training individual exercise prescription for resistance training. dietary, and aerobic exercise: hypocaloric diet individual prescription for aerobic training. |
|
|
|
| Secondary | Skeletal Muscle Mass | Measure skeletal muscle mass in kg by DEXA analysis pre and post intervention. | Analysis completed on all participants with DEXA measurement (n=78). | Posted | Least Squares Mean | Standard Error | kg | 20 weeks |
|
|
|
|
| Secondary | Thigh Skeletal Muscle Mass | Measure skeletal muscle mass by MRI analysis pre and post intervention. | Analysis completed on all participants with thigh MRI. | Posted | Least Squares Mean | Standard Error | cm^2 | 20 weeks |
|
|
|
|
| Secondary | Thigh Muscle Composition | MRI skeletal muscle to intermuscular fat ratio | Analysis completed on all participants with MRI measurements. | Posted | Least Squares Mean | Standard Error | ratio | 20 weeks |
|
|
|
|
| Secondary | Muscle Strength | maximal isokinetic knee extensor strength (Newton-meters, Nm) using an isokinetic dynamometer (Biodex®) | Analysis completed on all participants with Biodex measures. | Posted | Least Squares Mean | Standard Error | Nm | 20 weeks |
|
|
|
|
| Secondary | Muscle Quality | knee extensor strength to thigh muscle area assessed by MRI (Nm/cm2). | Analysis completed on all participants with MRI and Biodex measurements. | Posted | Least Squares Mean | Standard Error | Nm/cm^2 | 20 weeks |
|
|
|
|
| Secondary | Quality of Life Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score | The KCCQ Overall Summary Summary Score is a heart failure disease-specific quality of life measure encompassing domains of physical limitation, HF symptoms, quality of life, and social limitation scored on a scale of 0-100 with higher scores indicating better health status. | Analysis completed on all participants with KCCQ assessment. | Posted | Least Squares Mean | Standard Error | score on a scale | 20 weeks |
|
|
|
|
| Secondary | Quality of Life Measured by Short Form 36 Item Questionnaire (SF-36) | The SF-36 is a quality of life assessment with 2 component scores (Physical Composite Score and Mental Composite Score) ranging 0-100 with higher scores indicating better health status. | Analysis completed on all participants with SF-36 assessment. | Posted | Least Squares Mean | Standard Error | score on a scale | 20 weeks |
|
|
|
|
| Other Pre-specified | Mitochondrial Content | Porin citrate synthase pre and post intervention. | Not Posted | 20 weeks | Participants |
| Other Pre-specified | Mitochondrial Function | respiratory control ratio and mitofusin 2 concentration.pre and post intervention. | Not Posted | 20 weeks | Participants |
| 0 |
| 44 |
| 6 |
| 44 |
| 24 |
| 44 |
| EG001 | Dietary, Aerobic, and Resistance Training | Intervention for diet-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. Intervention for aerobic exercise-Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individual exercise prescription will be developed for aerobic training. Intervention for resistance training- Additional weight resistant exercise will be added to this arm. dietary, aerobic and resistance training: hypocaloric diet individual exercise prescription for aerobic training individual exercise prescription for resistance training. dietary, and aerobic exercise: hypocaloric diet individual prescription for aerobic training. | 0 | 44 | 6 | 44 | 25 | 44 |
| Cellulitis | Infections and infestations | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Heart failure exacerbation | Cardiac disorders | Non-systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Atypical chest pain | General disorders | Non-systematic Assessment |
|
| Rectal bleeding | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diverticulitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Acute renal failure | Renal and urinary disorders | Non-systematic Assessment |
|
| Spinal surgery | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| acute pancreatitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| bursitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| broken tooth | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| cellulitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| chest pain | Cardiac disorders | Non-systematic Assessment |
|
| heart failure exacerbation | Cardiac disorders | Non-systematic Assessment |
|
| COPD exacerbation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| diabetic ulcer | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| elevated ocular pressure | Eye disorders | Non-systematic Assessment |
|
| esophageal spasm | Gastrointestinal disorders | Non-systematic Assessment |
|
| fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| foot pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| gastroenteritis | Infections and infestations | Non-systematic Assessment |
|
| headache | Nervous system disorders | Non-systematic Assessment |
|
| hypertension | Vascular disorders | Non-systematic Assessment |
|
| hypoglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| hypotension | Vascular disorders | Non-systematic Assessment |
|
| knee pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| finger laceration | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| leg pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| muscle strain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| neck pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| non-cardiac chest pain | General disorders | Non-systematic Assessment |
|
| post-menopausal bleeding | Reproductive system and breast disorders | Non-systematic Assessment |
|
| presyncope | Nervous system disorders | Non-systematic Assessment |
|
| shoulder pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| upper respiratory infection | Infections and infestations | Non-systematic Assessment |
|
| urinary tract infections | Renal and urinary disorders | Non-systematic Assessment |
|
| vomitting | Gastrointestinal disorders | Non-systematic Assessment |
|
| dizziness | Nervous system disorders | Non-systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| hip pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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| D009748 |
| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |