Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-01-06 @ 9:48 PM
Study NCT ID:
NCT02318459
Status:
COMPLETED
Last Update Posted:
2016-11-03
First Post:
2014-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Intensity Interval Training in Geriatrics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018908', 'term': 'Muscle Weakness'}, {'id': 'D020233', 'term': 'Gait Disorders, Neurologic'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-02', 'studyFirstSubmitDate': '2014-11-07', 'studyFirstSubmitQcDate': '2014-12-11', 'lastUpdatePostDateStruct': {'date': '2016-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients who complete the rehabilitation program', 'timeFrame': '2 weeks'}], 'secondaryOutcomes': [{'measure': 'Distance walked in the 6MWT', 'timeFrame': '2 weeks'}, {'measure': 'Muscle strength assessed for the upper and lower extremities', 'timeFrame': '2 weeks', 'description': 'upper extremity : handgrip strength using the Baseline Pneumatic Bulb Hand Dynamometer Pinch Gauge; Lower exremity : knee flexion \\& extension and ankle flexion \\& extension using Microfet2™portable Dynamometer.'}, {'measure': 'Step variability changes as a measure of quality of ambulation', 'timeFrame': '2 weeks', 'description': 'Variability measured with GaitRite step analysis system'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Muscle Weakness', 'Gait, Unsteady']}, 'referencesModule': {'references': [{'pmid': '32503465', 'type': 'DERIVED', 'citation': 'Pires Peixoto R, Trombert V, Poncet A, Kizlik J, Gold G, Ehret G, Trombetti A, Reny JL. Feasibility and safety of high-intensity interval training for the rehabilitation of geriatric inpatients (HIITERGY) a pilot randomized study. BMC Geriatr. 2020 Jun 5;20(1):197. doi: 10.1186/s12877-020-01596-7.'}]}, 'descriptionModule': {'briefSummary': 'This is a pilot study for evaluating the feasibility of using High Intensity Interval Training in geriatric hospitalized patients compared to the standard current rehabilitation practice.', 'detailedDescription': 'High Intensity Interval Training (HIIT) has shown a superior effectiveness and efficiency when compared to Moderate Intensity Continuous Training (MICT) in several types of patients and in healthy subjects. There are no data on HIIT in a general geriatric population. This study is a pilot study evaluating the feasibility of using HIIT in geriatric hospitalized patients compared to the standard current rehabilitation practice without HIIT. It is our desire to perform a larger randomized comparative trial between HIIT and MICT if the pilot study proves its feasibility.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients aged 65 years and older hospitalized for rehabilitation after an acute medical condition\n* Expected duration of the rehabilitation ≥ 2 weeks\n* Ability to follow instructions to perform a Timed up and Go Test\n* Ability to perform exercises\n* Willing to participate in 4 sessions of HIIT per week for 2 weeks\n\nExclusion Criteria:\n\n* Any acute condition with tachycardia, hypotension or fever.\n* Abnormal cycle ergometer stress test with\n* significant ECG modification\n* decrease of more than 20 mmHg of the blood pressure with exercise\n* angina\n* ST depression at a workload \\<6 METs\n* Inability to reach an intensity of 15/20 in the Borg's scale of perceived exertion\n* Any unresolved acute medical or surgical condition of the following kind:\n* acute heart failure\n* acute coronary syndrome \\< 1 month\n* strole \\< 1 month\n* active pericarditis / myocarditis / endocarditis\n* thromboembolic disease with \\< 2 weeks of anticoagulation\n* acute infection requiring intravenous treatment\n* ongoing intravenous perfusion\n* surgery \\< 2 months\n* recent bone fracture\n* Previous episode of primary cardiac arrest (ie, cardiac arrest that did not occur in the presence of an acute myocardial infarction or during a cardiac procedure).\n* Severe heart failure (NYHA III and IV)\n* Severe stenotic or regurgitant valvular disease\n* Uncontrolled hypertension at rest (SBP≥160mmHg, DBP≥100mmHg)\n* Uncontrolled dysrhythmia\n* Non-sustained ventricular tachycardia with exercise\n* Implanted defibrillator\n* Obstructive cardiomyopathy\n* Resting HR \\> 100/min\n* Severe peripheral artery disease\n* Severe COPD (VEMS \\< 50%)\n* Exercise-induced asthma\n* Oxygen dependency\n* Muscular-skeletal anomaly that may limit exercise participation\n* Delirium\n* Inability to follow instructions\n* Inability to consent"}, 'identificationModule': {'nctId': 'NCT02318459', 'acronym': 'HIITERGY', 'briefTitle': 'High Intensity Interval Training in Geriatrics', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'High Intensity Interval Training for thE Rehabilitation of Geriatric Patients - a Feasibility Pilot studY.', 'orgStudyIdInfo': {'id': '13-257'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'high intensity interval training-HIIT', 'description': 'HIIT 4 times a week, 30 minutes duration', 'interventionNames': ['Other: high intensity interval training-HIIT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditionnal rehabilitation', 'description': 'Traditionnal group rehabilitation 3 times a week, 1 hour duration.', 'interventionNames': ['Other: Traditionnal group rehabilitation']}], 'interventions': [{'name': 'high intensity interval training-HIIT', 'type': 'OTHER', 'description': 'HIIT 4 times a week, 30 minutes duration', 'armGroupLabels': ['high intensity interval training-HIIT']}, {'name': 'Traditionnal group rehabilitation', 'type': 'OTHER', 'description': 'Traditionnal group rehabilitation, 3 times a week, 1 hour duration', 'armGroupLabels': ['Traditionnal rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1226', 'city': 'Geneva', 'state': 'Thônex', 'country': 'Switzerland', 'facility': 'Hôpital des Trois-Chêne (HUG)', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'overallOfficials': [{'name': 'Jean-Luc Reny, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Geneva'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of division, Internal medicine and rehabilitation Trois-Chêne', 'investigatorFullName': 'Jean-Luc Reny', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}