Ignite Creation Date:
2025-12-24 @ 12:39 PM
Ignite Modification Date:
2026-03-03 @ 12:35 AM
Study NCT ID:
NCT03247361
Status:
UNKNOWN
Last Update Posted:
2018-11-07
First Post:
2017-08-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-intensity vs. Low-intensity Inspiratory Muscle Training in Patients With Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2020-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-05', 'studyFirstSubmitDate': '2017-08-09', 'studyFirstSubmitQcDate': '2017-08-10', 'lastUpdatePostDateStruct': {'date': '2018-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aerobic Capacity', 'timeFrame': '10 weeks', 'description': 'Six-minute walk test'}, {'measure': 'Health-Related Quality of Life: MLHFQ', 'timeFrame': '10 weeks', 'description': 'Health-Related Quality of Life will be measured by a questionnaire (Minnesota Living with Heart Failure questionnaire - MLHFQ)'}], 'secondaryOutcomes': [{'measure': 'Respiratory muscle strength', 'timeFrame': '10 weeks', 'description': 'Maximal respiratory pressures'}, {'measure': 'Disability', 'timeFrame': '10 weeks', 'description': 'The World Health Organization Disability Assessment Schedule (WHODAS 2.0)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart Failure; Rehabilitation'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'It is well-known that muscle weakness and deconditioning play an important role in low exercise capacity of patients with HF. Interestingly, not only peripheral muscles are impaired, but also respiratory muscles. Studies have shown that patients with HF may have, in addition to decreasing maximal inspiratory muscle strength and endurance, metabolic and structural impairments in diaphragm fibers. Moreover, exercise capacity and weakness of inspiratory muscles have been associated with low quality of life and poor prognosis, which make the addition of inspiratory muscle training (IMT) reasonable in cardiovascular rehabilitation.The specifications of the loads to be imposed during IMT is the main factor determining the outcome. Studies of IMT have highlighted the need for a fixed inspiratory workload during exercise. Thus, purpose of this report was to perform a randomized clinical trial of the effects of addition of high-intensity vs. low-intensity IMT to combined aerobic and resistance Exercise in patients with heart failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The target population consists of adults patients aged ≥ 18 years with heart failure and New York Heart Association (NYHA) class I-III.\n\nExclusion Criteria:\n\n* Unstable angina;\n* coronary revascularization;\n* Decompensated heart failure functional class IV (NYHA);\n* Recent transplant or hospitalization (6 months \\<);\n* Chronic Obstructive Pulmonary Disease;\n* Neuromuscular, Orthopedic, Neurologic and Neoplastic Diseases;\n* Recent myocardial infarction or cardiac surgery (less than 6 months);\n* Atrial Fibrillation.'}, 'identificationModule': {'nctId': 'NCT03247361', 'briefTitle': 'High-intensity vs. Low-intensity Inspiratory Muscle Training in Patients With Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Bahia'}, 'officialTitle': 'The Addition of High-intensity vs. Low-intensity Inspiratory Muscle Training to Combined Aerobic and Resistance Exercise in Patients With Heart Failure', 'orgStudyIdInfo': {'id': 'FUBahia HIIT IMT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-intensity IMT', 'description': 'High-intensity IMT + Aerobic/resistance exercise\n\nIMT: Training loads will be adjusted weekly to the maximal inspiratory pressure (MIP). In the first 2 weeks as adaptation, the protocol will be of 2 minutes warm-up with intensity 20% of MIP. The training will have 7 peaks of intensity with 70% of MIP for 30 sec, with 30-sec of passive rest between the peaks, finishing the training with 20% of MIP for 2 min, totaling 10 min and 30 sec. From the third week the protocol will be of 2 min warm-up with intensity 30% of MIP. The training will have 7 peaks of intensity with 70% of MIP for 60 sec, with 60-second of passive rest between the peaks, finishing the training with 20% of MIP for 2 min, totaling 17 min.\n\nExercise: see group Combined aerobic/resistance exercise', 'interventionNames': ['Other: High-intensity IMT + Aerobic/resistance exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low-intensity IMT', 'description': 'Low-intensity IMT + Aerobic/resistance exercise\n\nIMT:Training loads will be also adjusted weekly to the maximal inspiratory pressure (MIP). In the first two weeks as adaptation, the protocol will be of 2 minutes warm-up with intensity 20% of MIP. The training will be held with 3 sets of 15 repetitions, with 40% of MIP, finishing the training with 20% of MIP for 2 minutes. From the third week the protocol will be of 2 minutes warm-up with intensity 30% of MIP. The training will be held with 3 sets of 15 repetitions, with 60% of MIP, finishing the training with 30% of MIP for 2 minutes.\n\nExercise: see group Combined aerobic/resistance exercise', 'interventionNames': ['Other: Low-intensity IMT + Aerobic/resistance exercise']}, {'type': 'SHAM_COMPARATOR', 'label': 'Aerobic/resistance exercise', 'description': 'Sham IMT + Aerobic/resistance exercise\n\nAerobic session will consist of a 4-min of warm-up, 20 minutes of exercise, and 4 min of cool-down. Intensity will set by the formula: Training HR = (maximum HR - resting HR) × intensity % + resting HR. Patients will exercise using 30 seconds, high-intensity work phases 0.7% followed by 1-minute recovery bouts 0.5%. Resistance exercise will consist of dynamic lower and upper limb exercise. Upper limb exercises will include 3 sets of exercises for each muscle group performed with 10 repetitions each. Lower limb exercises will include 3 sets of exercises for each muscle group performed with 12 repetitions each. Resistance exercises will be performed at 12-MR.', 'interventionNames': ['Other: Sham IMT + Aerobic/resistance exercise']}], 'interventions': [{'name': 'High-intensity IMT + Aerobic/resistance exercise', 'type': 'OTHER', 'description': 'High-intensity IMT', 'armGroupLabels': ['High-intensity IMT']}, {'name': 'Low-intensity IMT + Aerobic/resistance exercise', 'type': 'OTHER', 'description': 'Low-intensity IMT', 'armGroupLabels': ['Low-intensity IMT']}, {'name': 'Sham IMT + Aerobic/resistance exercise', 'type': 'OTHER', 'description': 'Aerobic and resistance exercise', 'armGroupLabels': ['Aerobic/resistance exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40100-110', 'city': 'Salvador', 'state': 'Estado de Bahia', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Mansueto G Neto, PhD', 'role': 'CONTACT'}], 'facility': 'Mansueto Gomes Neto', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}], 'centralContacts': [{'name': 'Mansueto Gomes-Neto, PhD', 'role': 'CONTACT', 'email': 'mansueto.neto@ufba.br', 'phone': '55-71-999188277'}], 'overallOfficials': [{'name': 'Mansueto Gomes-Neto, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Bahia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Bahia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal researcher', 'investigatorFullName': 'Mansueto Gomes Neto', 'investigatorAffiliation': 'Federal University of Bahia'}}}}