Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT03252132
Status:
COMPLETED
Last Update Posted:
2021-08-19
First Post:
2017-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Resistance Training in Patients With Diabetic Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D018908', 'term': 'Muscle Weakness'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'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': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'International, randomized controlled training trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-17', 'studyFirstSubmitDate': '2017-08-10', 'studyFirstSubmitQcDate': '2017-08-14', 'lastUpdatePostDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraepidermal nerve fiber density (IENFD)', 'timeFrame': 'Change from baseline IENFD at 12 weeks', 'description': '1-2 small biopsies of 3 mm will be performed before and after the 12-week training period to evaluate small nerve fiber function.'}, {'measure': 'Muscle strength (isokinetic strength)', 'timeFrame': 'Change from baseline IENFD at 12 weeks', 'description': 'Isokinetic dynamometry will be used to determine the maximal isokinetic strength of the flexors and extensors at the knee, hip and ankle.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2', 'Polyneuropathy Diabetes', 'Diabetes Complications', 'Diabetic Peripheral Neuropathy', 'Muscle Weakness', 'Fall Patients']}, 'referencesModule': {'references': [{'pmid': '35048156', 'type': 'DERIVED', 'citation': 'Khan KS, Overgaard K, Tankisi H, Karlsson P, Devantier L, Gregersen S, Jensen TS, Finnerup NB, Pop-Busui R, Dalgas U, Andersen H. Effects of progressive resistance training in individuals with type 2 diabetic polyneuropathy: a randomised assessor-blinded controlled trial. Diabetologia. 2022 Apr;65(4):620-631. doi: 10.1007/s00125-021-05646-6. Epub 2022 Jan 19.'}]}, 'descriptionModule': {'briefSummary': 'This is a population-based study of type 2 diabetes patients with and without neuropathy recruited from the Danish National Type 2 Diabetes cohort (DD2).\n\nDiabetic patients with neuropathy may suffer from incapacitating symptoms such as pain, muscle weakness and impaired balance. Muscle weakness may cause reduced balance and postural instability increasing the risk of frequent falls and thereby increased morbidity and mortality. Thus, diabetic neuropathy is associated with significant disabilities having major impact on activities of daily living and quality of life.\n\nThe effects of resistance training on neuropathy symptoms, muscle strength and muscle structure in patients with and with diabetic neuropathy will be examined.', 'detailedDescription': 'Perspective: The studies will likely improve the understanding of diabetic neuropathy and the relation between risk of falls in patients with and without motor dysfunction. The results may enable new and more precise recommendations for exercise in diabetic patients with diabetic neuropathy. In addition, the results may lead to a better understanding of the mechanisms underlying the effects of training. The improvement of motor function may lead to improved gait stability, fewer fall injuries and better quality of life for type 2 diabetes patients, resulting in lower morbidity and mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of type 2 diabetes\n\nExclusion Criteria:\n\n* Neuropathy due to any other cause\n\n * BMI \\>40\n * Pacemaker\n * Comorbidity that contraindicates exercise\n * History of stroke with affection of the lower extremities\n * Ischemic heart disease\n * Any other neurological disease\n * Pregnancy'}, 'identificationModule': {'nctId': 'NCT03252132', 'briefTitle': 'Resistance Training in Patients With Diabetic Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'Danish Pain Research Center'}, 'officialTitle': 'Resistance Training in Patients With Diabetic Neuropathy', 'orgStudyIdInfo': {'id': 'IDNC-DD2-MUSCLE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '12-week resistance training', 'interventionNames': ['Other: 12-week resistance training']}, {'type': 'NO_INTERVENTION', 'label': 'No training'}], 'interventions': [{'name': '12-week resistance training', 'type': 'OTHER', 'description': 'Training will consist of a minimum of 5 supervised training sessions every 2 weeks and each session will be approximately 60 minutes in duration. Patients will be performing resistance training consisting of at least 3 exercises affecting the largest muscle groups of the body, training the most basic movement patterns that work the entire body as a coordinated system. Patients will train according to a linear progressive model with a slow increase in weight every training session focusing on the flexors, extensors of the ankle and knee and on flexors, extensors and abductors of the hip.', 'armGroupLabels': ['12-week resistance training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Danish Pain Research Center, Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Karolina Snopek, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Danish Pain Research Center, Aarhus University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Pain Research Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Odense University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}