Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-28 @ 12:55 PM
Study NCT ID:
NCT04216368
Status:
COMPLETED
Last Update Posted:
2020-02-13
First Post:
2019-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Balance Trainning for Sarcopenic Inpatients Aged 80+ Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, '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': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-11', 'studyFirstSubmitDate': '2019-12-31', 'studyFirstSubmitQcDate': '2019-12-31', 'lastUpdatePostDateStruct': {'date': '2020-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fall rates', 'timeFrame': 'One year', 'description': 'The incidence of falls during the first year of follow-up'}, {'measure': 'The change of activities of daily living', 'timeFrame': '3 Months', 'description': 'Basic activities of daily living (BADL) assessed by Barthel Index'}], 'secondaryOutcomes': [{'measure': 'The change of usual gait speed', 'timeFrame': '3 months'}, {'measure': 'The change of handgrip strength', 'timeFrame': '3 months'}, {'measure': 'The change of the score of Short Physical Performance Battery', 'timeFrame': '3 Months', 'description': 'The Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons.'}, {'measure': 'The change of the score of Timed Up and Go test', 'timeFrame': '3 Months', 'description': 'The Timed Up and Go test (TUG) is a simple test used to measure basic functional mobility and safety with mobility.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sarcopenia']}, 'descriptionModule': {'briefSummary': 'Resistance training and aerobic exercise have been recommended for sarcopenic patients. However, whether balance training would further benefit for sarcopenic patients on the basis of resistance training and aerobic exercise remains unclear. The purpose of this study is to explore the effect of balance training on improving the mobility of elderly patients with sarcopenia. Balance training involves doing exercises that strengthen the muscles that help keep the aged upright, including the legs and core. These kinds of exercises can improve stability and help prevent falls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '80 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria：\n\n* Sarcopenia defined by the Asia Working Group of Sarcopenia (AWGS)\n* Agree to participant this study and sign the informed consent\n* Aged 80 years or over\n\nExclusion Criteria:\n\n* Patients who could not follow the training plan due to cognitive impairment, emotional problems or any other reasons;\n* Severe heart and lung diseases;\n* Renal insufficiency;\n* Any type of tumor;\n* Bedridden patients'}, 'identificationModule': {'nctId': 'NCT04216368', 'briefTitle': 'Balance Trainning for Sarcopenic Inpatients Aged 80+ Years', 'organization': {'class': 'OTHER', 'fullName': 'West China Hospital'}, 'officialTitle': 'Effect of Balance Training on Mobility and Activities of Daily Living in Sarcopenic Inpatients Aged 80+Years', 'orgStudyIdInfo': {'id': '2019（596）'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental group', 'interventionNames': ['Behavioral: balance training', 'Behavioral: resistance training']}, {'type': 'OTHER', 'label': 'controlled group', 'interventionNames': ['Behavioral: resistance training']}], 'interventions': [{'name': 'balance training', 'type': 'BEHAVIORAL', 'description': 'The training to improve balance is to work on the core muscle groups that help to maintain your posture.,and increase muscular strength.', 'armGroupLabels': ['experimental group']}, {'name': 'resistance training', 'type': 'BEHAVIORAL', 'description': 'Resistance training is a form of exercise that improves muscular strength and endurance. During a resistance training workout, you move your limbs against resistance provided by your body weight, gravity, bands, weighted bars or dumbbells.', 'armGroupLabels': ['controlled group', 'experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610064', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'West China Hospital，Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'overallOfficials': [{'name': 'Ming Yang', 'role': 'STUDY_DIRECTOR', 'affiliation': 'West China Hospital'}, {'name': 'Jiaojiao Jiang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West China Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuxiang Liang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Physiotherapist', 'investigatorFullName': 'Yuxiang Liang', 'investigatorAffiliation': 'West China Hospital'}}}}