Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-01-24 @ 3:56 AM
Study NCT ID:
NCT02435667
Status:
COMPLETED
Last Update Posted:
2021-02-03
First Post:
2015-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Resistance Training in HFpEF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054144', 'term': 'Heart Failure, Diastolic'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-01', 'studyFirstSubmitDate': '2015-04-29', 'studyFirstSubmitQcDate': '2015-05-01', 'lastUpdatePostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone density and strength', 'timeFrame': '12 weeks', 'description': 'DEXA scan'}, {'measure': 'Cardiopulmonary Function', 'timeFrame': '12 weeks', 'description': 'Cardiopulmonary bike exercise'}, {'measure': 'Quality of Life', 'timeFrame': '12 weeks', 'description': 'Questionnaire'}, {'measure': 'Blood Biomarkers', 'timeFrame': '12 weeks', 'description': 'Blood draw'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Resistance Training', 'Exercise', 'Heart Failure preserved Ejection Fraction'], 'conditions': ['Heart Failure Preserved Ejection Fraction']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The objective of this proposal is to determine the effect of resistance exercise training on locomotor muscle function, exercise capacity, exertional symptoms, and quality of life in HF patients with preserved ejection fraction (HFpEF).', 'detailedDescription': 'In this randomized controlled pilot study of resistance exercise training in patients with HFpEF, the investigators will recruit 24 HFpEF patients who will be randomized to resistance exercise training (RT - n=12) or no resistance exercise training (standard care control group \\[CTL\\] - n=12). The investigators will have baseline and follow-up measures of clinical characteristics, leg muscle strength, quality of life, lean muscle mass (body composition via DXA including segmental lean mass), maximal cardiopulmonary exercise test (peak VO2, peak work, ventilatory efficiency), constant-load submaximal cardiopulmonary exercise test with speckle tracking echocardiography (exertional dyspnea and fatigue at matched workloads, cardiac output, diastolic function, left ventricular strain, ventilation, gas exchange, and locomotor muscle neural feedback).\n\nParticipants will be asked to make 4 separate study visits. Those randomized to undergo Resistance Training will be expected to make those visits as well.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'All patients will be managed by their primary care physician or cardiologist with additional review and oversight by Dr. Borlaug (Co-Investigator) prior to enrollment to ensure adequacy of inclusion and exclusion criteria and that participation in exercise testing and resistance exercise training is safe.\n\nInclusion Criteria, includes:\n\n* Clinical diagnosis of HFpEF.\n* Patients 18-80 yrs old with a history stable (no medication changes in past 6 weeks (w/duration of diagnosis \\>6 months).\n* New York Heart Association class I-III.\n* Ejection fraction ≥40%.\n* Current non-smokers with \\<15 pack year history.\n* Non-pregnant women, and individuals who are able to exercise (i.e. without orthopedic limitations or neuromuscular disorders).\n\nExclusion Criteria, includes:\n\n* Patient refusal to participate.\n* Significant orthopedic or neuromuscular limitations\n* Significant cognitive impairment\n* Hemoglobin \\< 7.0 g/d.'}, 'identificationModule': {'nctId': 'NCT02435667', 'briefTitle': 'Resistance Training in HFpEF', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Resistance Exercise Training in Heart Failure With Preserved Ejection Fraction (Resist - HFpEF)', 'orgStudyIdInfo': {'id': '15-000320'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Resistance Exercise Training', 'description': 'Entails 36 supervised resistance exercise training sessions (3 sessions per week for 12 weeks). Each exercise session will be supervised by a trained, certified Exercise Physiologist specializing in Cardiac Rehabilitation. The specific resistance exercise training will include Aerobic Exercise, Resistance Exercise, and Core Strengthening Exercises. Other baseline and follow-up tests include: DEXA bone scan, Blood Draw, Cardiopulmonary Max Exercise Test, Quality of Life Questionnaire, and a Submaximal Exercise Test.', 'interventionNames': ['Other: Resistance Exercise Training', 'Radiation: DEXA bone scan', 'Other: Cardiopulmonary Max Exercise Test', 'Other: Quality of Life Questionnaire', 'Other: Submaximal Exercise Test', 'Other: Blood Draw']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Standard Care', 'description': 'No resistance exercise training. Patients will stay on their current healthcare regimen as previously assigned by their physician. Patients will still undergo baseline and follow-up tests similar to the Resistance Exercise Training group, including: DEXA bone scan, Blood Draw, Cardiopulmonary Max Exercise Test, Quality of Life Questionnaire, and a Submaximal Exercise Test.', 'interventionNames': ['Radiation: DEXA bone scan', 'Other: Cardiopulmonary Max Exercise Test', 'Other: Quality of Life Questionnaire', 'Other: Submaximal Exercise Test', 'Other: Blood Draw']}], 'interventions': [{'name': 'Resistance Exercise Training', 'type': 'OTHER', 'description': '1. Aerobic Exercise\n\n a. Each participant will engage in 5 minutes of aerobic based exercise on an arm/leg ergometer (NuStep Cross Trainer) at an intensity of 12-14 on the Borg Rating of Perceived Exertion Scale as a warm-up prior to the exercise session and again as a cool-down at the end of the exercise session.\n2. Resistance Exercise - 2 sets of 8-12 repetitions - beginning at 60% of the initial 1 RM.\n\n a) Leg Extension, b) Bicep Curl, c) Leg Press, d) Chest Press, e) Leg Curl, f)Seated Row (horizontal or pulldown), g) Calf Raises\n3. Core Strengthening Exercises a. 5-10 minutes of stability ball and balance exercises', 'armGroupLabels': ['Resistance Exercise Training']}, {'name': 'DEXA bone scan', 'type': 'RADIATION', 'description': 'A DEXA scan that provides bone density measures.', 'armGroupLabels': ['Resistance Exercise Training', 'Standard Care']}, {'name': 'Cardiopulmonary Max Exercise Test', 'type': 'OTHER', 'description': 'Pedaling on a cycle ergometer to volitional fatigue.', 'armGroupLabels': ['Resistance Exercise Training', 'Standard Care']}, {'name': 'Quality of Life Questionnaire', 'type': 'OTHER', 'description': 'A 10 minute questionnaire that measures quality of life.', 'armGroupLabels': ['Resistance Exercise Training', 'Standard Care']}, {'name': 'Submaximal Exercise Test', 'type': 'OTHER', 'description': 'Two short submaximal constant-load exercise sessions at 20 Watts. Each session will include 6 minutes of cycling (baseline). Following baseline, the sessions will be randomized to continued constant-load cycling for an additional 9 minutes (for echocardiographic measures) or randomized sub-systolic inflation of bilateral thigh pressure tourniquets to 40 and 80 mmHg for 3 minutes with 3 minutes of deflation between inflations to stimulate locomotor muscle neural feedback.', 'armGroupLabels': ['Resistance Exercise Training', 'Standard Care']}, {'name': 'Blood Draw', 'type': 'OTHER', 'description': 'A blood draw amounting to 1 teaspoon of blood drawn.', 'armGroupLabels': ['Resistance Exercise Training', 'Standard Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Thomas Olson, MS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Thomas P. Olson, M.S., Ph.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}