Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
Study NCT ID:
NCT00959660
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2009-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Exercise Intolerance in Elderly Patients With Diastolic Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054144', 'term': 'Heart Failure, Diastolic'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dkitzman@wakehealth.edu', 'phone': '336-716-3274', 'title': 'Dalane W. Kitzman, M.D.', 'organization': 'Wake Forest School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '20 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Exercise Training', 'description': '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.\n\nExercise: walking, treadmill and bicycle exercise', 'otherNumAtRisk': 26, 'otherNumAffected': 2, 'seriousNumAtRisk': 26, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Dietary Intervention', 'description': '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.\n\nDietary Intervention: Subjects will be provided meals and instructions for individual food selections.', 'otherNumAtRisk': 24, 'otherNumAffected': 1, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Attention Control', 'description': '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.\n\nAttention Control: control group- continue their previously randomized life style', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Diet and Exercise', 'description': 'The diet and exercise group is a combination of the two groups previously described.\n\nExercise: walking, treadmill and bicycle exercise\n\nDiet and exercise: Combination of the exercise and diet group as previously described.', 'otherNumAtRisk': 25, 'otherNumAffected': 2, 'seriousNumAtRisk': 25, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stress fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tendon tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Heart failure exacerbation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leg edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Exercise Capacity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise Training', 'description': '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.\n\nExercise: walking, treadmill and bicycle exercise'}, {'id': 'OG001', 'title': 'Dietary Intervention', 'description': '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.\n\nDietary Intervention: Subjects will be provided meals and instructions for individual food selections.'}, {'id': 'OG002', 'title': 'Attention Control', 'description': '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.\n\nAttention Control: control group- continue their previously randomized life style'}, {'id': 'OG003', 'title': 'Diet and Exercise', 'description': 'The diet and exercise group is a combination of the two groups previously described.\n\nExercise: walking, treadmill and bicycle exercise\n\nDiet and exercise: Combination of the exercise and diet group as previously described.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.5', 'groupId': 'OG000', 'lowerLimit': '15.1', 'upperLimit': '15.9'}, {'value': '15.5', 'groupId': 'OG001', 'lowerLimit': '15.1', 'upperLimit': '15.9'}, {'value': '14.1', 'groupId': 'OG002', 'lowerLimit': '13.5', 'upperLimit': '14.7'}, {'value': '16.6', 'groupId': 'OG003', 'lowerLimit': '16.0', 'upperLimit': '17.2'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'pValueComment': 'Main effects analysis with Diet vs. No Diet.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'pValueComment': 'Main effects analysis with Exercise vs. No Exercise.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.'}], 'paramType': 'MEAN', 'timeFrame': '20 weeks', 'description': '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.', 'unitOfMeasure': 'ml/kg/min', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise Training', 'description': '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.\n\nExercise: walking, treadmill and bicycle exercise'}, {'id': 'OG001', 'title': 'Dietary Intervention', 'description': '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.\n\nDietary Intervention: Subjects will be provided meals and instructions for individual food selections.'}, {'id': 'OG002', 'title': 'Attention Control', 'description': '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.\n\nAttention Control: control group- continue their previously randomized life style'}, {'id': 'OG003', 'title': 'Diet and Exercise', 'description': 'The diet and exercise group is a combination of the two groups previously described.\n\nExercise: walking, treadmill and bicycle exercise\n\nDiet and exercise: Combination of the exercise and diet group as previously described.'}], 'classes': [{'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000', 'lowerLimit': '67', 'upperLimit': '75'}, {'value': '77', 'groupId': 'OG001', 'lowerLimit': '73', 'upperLimit': '81'}, {'value': '69', 'groupId': 'OG002', 'lowerLimit': '63', 'upperLimit': '75'}, {'value': '79', 'groupId': 'OG003', 'lowerLimit': '75', 'upperLimit': '84'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'pValueComment': 'Main effects analyses with Diet vs. No Diet.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.'}, {'pValue': '0.43', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'pValueComment': 'Main effects analysis for Exercise vs. No Exercise.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.'}], 'paramType': 'MEAN', 'timeFrame': '20 weeks', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Body Composition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise Training', 'description': '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.\n\nExercise: walking, treadmill and bicycle exercise'}, {'id': 'OG001', 'title': 'Dietary Intervention', 'description': '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.\n\nDietary Intervention: Subjects will be provided meals and instructions for individual food selections.'}, {'id': 'OG002', 'title': 'Attention Control', 'description': '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.\n\nAttention Control: control group- continue their previously randomized life style'}, {'id': 'OG003', 'title': 'Diet and Exercise', 'description': 'The diet and exercise group is a combination of the two groups previously described.\n\nExercise: walking, treadmill and bicycle exercise\n\nDiet and exercise: Combination of the exercise and diet group as previously described.'}], 'classes': [{'title': 'Total Fat', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000', 'lowerLimit': '43', 'upperLimit': '47'}, {'value': '42', 'groupId': 'OG001', 'lowerLimit': '40', 'upperLimit': '44'}, {'value': '47', 'groupId': 'OG002', 'lowerLimit': '45', 'upperLimit': '49'}, {'value': '40', 'groupId': 'OG003', 'lowerLimit': '38', 'upperLimit': '42'}]}]}, {'title': 'Total Non-Bone Lean', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '54'}, {'value': '50', 'groupId': 'OG001', 'lowerLimit': '50', 'upperLimit': '50'}, {'value': '53', 'groupId': 'OG002', 'lowerLimit': '53', 'upperLimit': '53'}, {'value': '50', 'groupId': 'OG003', 'lowerLimit': '48', 'upperLimit': '52'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'pValueComment': 'Main effects analyses with Diet vs. No Diet.', 'groupDescription': 'Total Body Fat Mass', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.'}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'pValueComment': 'Main effects analysis of Exercise vs. No Exercise.', 'groupDescription': 'Total Body Fat Mass', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'pValueComment': 'Main effects analyses with Diet vs. No Diet.', 'groupDescription': 'Total Non-Bone Lean Mass', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.'}, {'pValue': '0.25', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'pValueComment': 'Main effects analysis for Exercise vs. No Exercise.', 'groupDescription': 'Total Non-Bone Lean Mass', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.'}], 'paramType': 'MEAN', 'timeFrame': '20 weeks', 'description': 'Total Body Fat Mass and Total Non-bone Lean Mass via DEXA', 'unitOfMeasure': 'kg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Thigh Muscle Composition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise Training', 'description': '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.\n\nExercise: walking, treadmill and bicycle exercise'}, {'id': 'OG001', 'title': 'Dietary Intervention', 'description': '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.\n\nDietary Intervention: Subjects will be provided meals and instructions for individual food selections.'}, {'id': 'OG002', 'title': 'Attention Control', 'description': '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.\n\nAttention Control: control group- continue their previously randomized life style'}, {'id': 'OG003', 'title': 'Diet and Exercise', 'description': 'The diet and exercise group is a combination of the two groups previously described.\n\nExercise: walking, treadmill and bicycle exercise\n\nDiet and exercise: Combination of the exercise and diet group as previously described.'}], 'classes': [{'title': 'Thigh Subcutaneous Fat', 'categories': [{'measurements': [{'value': '155', 'groupId': 'OG000', 'lowerLimit': '149', 'upperLimit': '161'}, {'value': '143', 'groupId': 'OG001', 'lowerLimit': '137', 'upperLimit': '149'}, {'value': '164', 'groupId': 'OG002', 'lowerLimit': '158', 'upperLimit': '170'}, {'value': '144', 'groupId': 'OG003', 'lowerLimit': '138', 'upperLimit': '150'}]}]}, {'title': 'Thigh Skeletal Muscle', 'categories': [{'measurements': [{'value': '120', 'groupId': 'OG000', 'lowerLimit': '118', 'upperLimit': '122'}, {'value': '115', 'groupId': 'OG001', 'lowerLimit': '113', 'upperLimit': '117'}, {'value': '121', 'groupId': 'OG002', 'lowerLimit': '117', 'upperLimit': '125'}, {'value': '114', 'groupId': 'OG003', 'lowerLimit': '112', 'upperLimit': '116'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'pValueComment': 'Main effects analyses with Diet vs. No Diet.', 'groupDescription': 'Thigh Subcutaneous Fat', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.'}, {'pValue': '0.26', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'pValueComment': 'Main effects analysis for Exercise vs. No Exercise.', 'groupDescription': 'Thigh Subcutaneous Fat', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'pValueComment': 'Main effects analyses with Diet vs. No Diet.', 'groupDescription': 'Thigh Skeletal Muscle', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.'}, {'pValue': '0.26', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'pValueComment': 'Main effects analysis of Exercise vs. No Exercise.', 'groupDescription': 'Thigh Skeletal Muscle', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.'}], 'paramType': 'MEAN', 'timeFrame': '20 weeks', 'description': 'Thigh Skeletal Muscle and Subcutaneous Fat via MRI', 'unitOfMeasure': 'cm^2', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Exercise Training', 'description': '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.\n\nExercise: walking, treadmill and bicycle exercise'}, {'id': 'FG001', 'title': 'Dietary Intervention', 'description': '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.\n\nDietary Intervention: Subjects will be provided meals and instructions for individual food selections.'}, {'id': 'FG002', 'title': 'Attention Control', 'description': '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.\n\nAttention Control: control group- continue their previously randomized life style'}, {'id': 'FG003', 'title': 'Diet and Exercise', 'description': 'The diet and exercise group is a combination of the two groups previously described.\n\nExercise: walking, treadmill and bicycle exercise\n\nDiet and exercise: Combination of the exercise and diet group as previously described.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Exercise Training', 'description': '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.\n\nExercise: walking, treadmill and bicycle exercise'}, {'id': 'BG001', 'title': 'Dietary Intervention', 'description': '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.\n\nDietary Intervention: Subjects will be provided meals and instructions for individual food selections.'}, {'id': 'BG002', 'title': 'Attention Control', 'description': '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.\n\nAttention Control: control group- continue their previously randomized life style'}, {'id': 'BG003', 'title': 'Diet and Exercise', 'description': 'The diet and exercise group is a combination of the two groups previously described.\n\nExercise: walking, treadmill and bicycle exercise\n\nDiet and exercise: Combination of the exercise and diet group as previously described.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.5', 'spread': '5.9', 'groupId': 'BG000'}, {'value': '66.5', 'spread': '4.9', 'groupId': 'BG001'}, {'value': '65.6', 'spread': '4.8', 'groupId': 'BG002'}, {'value': '66.3', 'spread': '5.2', 'groupId': 'BG003'}, {'value': '66.5', 'spread': '5.2', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '81', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-12', 'studyFirstSubmitDate': '2009-08-14', 'resultsFirstSubmitDate': '2018-01-26', 'studyFirstSubmitQcDate': '2009-08-14', 'lastUpdatePostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-03-13', 'studyFirstPostDateStruct': {'date': '2009-08-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exercise Capacity', 'timeFrame': '20 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Quality of Life', 'timeFrame': '20 weeks', 'description': '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.'}, {'measure': 'Body Composition', 'timeFrame': '20 weeks', 'description': 'Total Body Fat Mass and Total Non-bone Lean Mass via DEXA'}, {'measure': 'Thigh Muscle Composition', 'timeFrame': '20 weeks', 'description': 'Thigh Skeletal Muscle and Subcutaneous Fat via MRI'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diastolic heart failure', 'Heart Failure', 'Elderly', 'Obesity'], 'conditions': ['Heart Failure, Diastolic', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '34774747', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '34344169', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '30007558', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '27693420', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '26746456', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Heart failure clinical score greater than or equal to 3\n* Age 60 and over\n* Normal ejection fraction greater than or equal to 50%\n* BMI greater than or equal to 30\n\nExclusion Criteria:\n\n* Valvular heart disease\n* Significant change in cardiac medication \\<4 weeks\n* Uncontrolled hypertension\n* Recent or debilitating stroke\n* Cancer or other noncardiovascular conditions with life expectancy less than 2 years\n* Significant Anemia\n* Renal insufficiency (creatinine \\>2.5mg/dl)\n* Psychiatric disease- uncontrolled major psychoses, depressions, dementia, or personality disorder\n* Plans to leave area within 6 months\n* Refuses informed consent\n* Failure to pass screening test:pulmonary function, echocardiogram,or exercise'}, 'identificationModule': {'nctId': 'NCT00959660', 'acronym': 'SECRET', 'briefTitle': 'Exercise Intolerance in Elderly Patients With Diastolic Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Study of the Effect of Caloric Restriction and Exercise Training in Patients With Heart Failure and a Normal Ejection Fraction.(SECRET)', 'orgStudyIdInfo': {'id': 'IRB00005668'}, 'secondaryIdInfos': [{'id': 'R37AG018915', 'link': 'https://reporter.nih.gov/quickSearch/R37AG018915', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise Training', 'description': '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.', 'interventionNames': ['Behavioral: Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dietary Intervention', 'description': '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.', 'interventionNames': ['Dietary Supplement: Dietary Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Attention control', 'description': '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.', 'interventionNames': ['Other: Attention Control']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Diet and Exercise', 'description': '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.', 'interventionNames': ['Behavioral: Exercise', 'Behavioral: Diet and exercise']}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': 'walking, treadmill and bicycle exercise', 'armGroupLabels': ['Diet and Exercise', 'Exercise Training']}, {'name': 'Dietary Intervention', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Subjects will be provided meals and instructions for individual food selections.', 'armGroupLabels': ['Dietary Intervention']}, {'name': 'Diet and exercise', 'type': 'BEHAVIORAL', 'description': 'Subjects will be provided meals and instructions for individual food selections and will undergo walking, treadmill and bicycle exercise.', 'armGroupLabels': ['Diet and Exercise']}, {'name': 'Attention Control', 'type': 'OTHER', 'description': 'control group- continue their previously randomized life style', 'armGroupLabels': ['Attention control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '271757', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Dalane W Kitzman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}