Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2026-01-28 @ 8:49 PM
Study NCT ID:
NCT02742792
Status:
UNKNOWN
Last Update Posted:
2017-10-23
First Post:
2016-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Strength Training on Sleep Apnea in the Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-19', 'studyFirstSubmitDate': '2016-04-01', 'studyFirstSubmitQcDate': '2016-04-14', 'lastUpdatePostDateStruct': {'date': '2017-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Apnea-hypopnea index', 'timeFrame': '12 weeks', 'description': 'Measured by out-of-center polysomnography'}], 'secondaryOutcomes': [{'measure': 'Muscle strength', 'timeFrame': '12 weeks', 'description': 'Measured by 1-repetition maximum strength test'}, {'measure': 'Muscle thickness', 'timeFrame': '12 weeks', 'description': 'Measured by ultrasound'}, {'measure': 'Muscle quality', 'timeFrame': '12 weeks', 'description': 'Measured by ultrasound'}, {'measure': 'Muscle strength of legs', 'timeFrame': '12 weeks', 'description': 'Measured by Sit-to-stand test'}, {'measure': 'Mobility', 'timeFrame': '12 weeks', 'description': 'Measured by Timed up and go test'}, {'measure': 'Grip strength', 'timeFrame': '12 weeks', 'description': 'Measured by Handgrip strength test'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sleep apnea', 'elderly', 'exercise'], 'conditions': ['Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '35561473', 'type': 'DERIVED', 'citation': 'da Silva RP, Martinez D, Uribe Ramos JM, Martins EF, Tedesco-Silva LM, Lopez P, Cadore EL. The effects of resistance exercise on obstructive sleep apnea severity and body water content in older adults: A randomized controlled trial. Sleep Med. 2022 Jul;95:37-46. doi: 10.1016/j.sleep.2022.04.014. Epub 2022 Apr 22.'}, {'pmid': '29058628', 'type': 'DERIVED', 'citation': 'da Silva RP, Martinez D, Lopez P, Cadore EL. Effect of strength training on sleep apnea severity in the elderly: study protocol for a randomized controlled trial. Trials. 2017 Oct 23;18(1):489. doi: 10.1186/s13063-017-2238-3.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the study is to evaluate the impact of strength training on sleep apneas in the elderly. Individuals aged between 65 and 80 years and that presenting apnea-hypopnea index between 20 and 50 events per hour, measured by out-of-center portable polysomnography, will be recruited. Those included will be randomized to two groups: Intervention: consisted of 12 weeks, twice a week, of strength training; or control: consisted of lifestyle recommendations.', 'detailedDescription': 'Obstructive sleep apnea (OSA) is a disorder that exposes the individual to repeated periods of hypoxia and awakenings during sleep. OSA occurs in up to one third of the population, constituting a public health problem. The prevalence of sleep apnea increases with age, reaching up to 90%. Its consequences include sympathetic nervous system activation, increased blood pressure and heart rate, myocardial contractility overload, decline in parasympathetic activity, oxidative stress, systemic inflammation, platelet activation, and impaired vascular endothelial function. OSA is a risk factor for hypertension, coronary artery disease, peripheral artery disease, heart failure, and arrhythmias. The classical treatment options for OSA are the use of continuous positive airway pressure, oral appliances for mandibular advancement, surgery, weight reduction, and lifestyle change, including recommendation of regular practice of exercise.\n\nPhysical exercise is accepted culturally and scientifically as a non-pharmacological intervention beneficial to health. Aerobic and resistance exercises improve the quality of sleep. There is evidence of improvement in the general well-being and, particularly in sleep. Promote or improve sleep through exercise is healthy, safe, and simple. A sedentary lifestyle is linked with a higher incidence and severity of sleep apnea. Increase in the number of hours of exercise reduces these problems. Exercise has been used with consistent results to treat OSA. The effect size of exercise in treatment of OSA ranges between 0.4 and 1.5 standard deviations. In a meta-analysis, totaling 129 participants, the mean effect was the reduction of 7 events per hour. Although the results of randomized clinical trials and other studies pointing to the decrease in AHI after physical training, all studies involved adult populations with an average age between 42 and 54 years. The role of exercise in the elderly with OSA, the most affected population, remains uninvestigated.\n\nThe research question is: What is the effect of strength training on the apnea-hypopnea index (AHI) in elderly with OSA? The objective of the study is to evaluate the impact of strength training on OSA in the elderly.\n\nThe trial will recruit individuals aged 65 to 80 years ascribed to a primary care unit linked to the university hospital. Individuals that accept to participate in the study, will undergo out-of-center polysomnography in order to detect and quantify the severity of OSA. Individuals with AHI between 20 and 50 events per hour will be eligible, and will be randomly allocated to the intervention or the control group. Randomization will be performed by sequence numbers generated by computer at randomization.com.\n\nIndividuals allocated to the intervention group will hold two sessions per week of strength training consisted of exercises for legs, arms, chest, back, and abdomen in the university Physical Education High School, during 12 weeks. The individuals allocated to the control group will receive advice on lifestyle and will participate in the meetings of an elderly social group in the basic health unit. All individuals from both groups will perform an evaluation consisting of body composition by bioelectrical impedance, maximum dynamic force by 1-repetition maximum strength test, quality and muscle thickness by ultrasound, and physical function by Sit-to-stand test, Timed up and go test and Handgrip strength test. All evaluations will be repeated at the end of the 12-week period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 65 and 80 years\n* Both genders\n* Not being engaged in regular structured resistance exercise\n* Apnea-hypopnea index between 20 and 50 events per hour\n* Time availability to include physical activity in routine\n* Consenting to participate in the survey\n\nExclusion Criteria:\n\n* Being in treatment for sleep apnea\n* Osteoarticular problems that compromise the exercises included in the project\n* Neuromuscular Problems\n* Serious illness\n* Uncontrolled hypertension\n* Acute myocardial infarction in the last year\n* Recent trauma of the upper airway\n* Other chronic diseases in treatment for over a month in the last year\n* Drugs with effect on the central nervous system'}, 'identificationModule': {'nctId': 'NCT02742792', 'briefTitle': 'Effect of Strength Training on Sleep Apnea in the Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Clinicas de Porto Alegre'}, 'officialTitle': 'Effect of Strength Training on Sleep Apnea in the Elderly', 'orgStudyIdInfo': {'id': '15-0613'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Resistance training', 'description': 'Resistance training, twice a week during 12 weeks.', 'interventionNames': ['Other: Resistance training']}, {'type': 'OTHER', 'label': 'Advice on lifestyle', 'description': 'Patients receive advice on lifestyle. Patients will be asked to participate in the elderly group meetings the basic health unit linked to the hospital.', 'interventionNames': ['Other: Advice on Lifestyle']}], 'interventions': [{'name': 'Resistance training', 'type': 'OTHER', 'description': 'Twenty-four strength training sessions consisted in exercises of extension and flexion knees, lat pull-down, elbow extension and flexion, sitting bench press and hip abduction.', 'armGroupLabels': ['Resistance training']}, {'name': 'Advice on Lifestyle', 'type': 'OTHER', 'description': 'Patients receive advice on lifestyle. Patients will be asked to participate in the elderly group meetings the basic health unit linked to the hospital.', 'armGroupLabels': ['Advice on lifestyle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90035-903', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital de Clínicas de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'overallOfficials': [{'name': 'Denis Martinez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Graduate Program in Cardiology and Cardiovascular Sciences, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil; Cardiology Unit, Hospital de Clinicas de Porto Alegre (HCPA - UFRGS), Porto Alegre, RS, Brazil'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Clinicas de Porto Alegre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}