Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-02-23 @ 8:06 PM
Study NCT ID:
NCT01752660
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
2012-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise in Severely Disabled Patients With MS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000076663', 'term': 'Endurance Training'}, {'id': 'D059039', 'term': 'Standard of Care'}], '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'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-17', 'studyFirstSubmitDate': '2012-11-12', 'studyFirstSubmitQcDate': '2012-12-14', 'lastUpdatePostDateStruct': {'date': '2013-07-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exercise compliance', 'timeFrame': 'Exercise compliance is registered immediatly after all planned exercise sessions during the 4 week intervention', 'description': 'Compliance to exercise is registered and serve as the primary outcome.'}, {'measure': 'Drop out rate', 'timeFrame': 'Number of participants who drop out is registered at the post measurement just after the intervention.'}], 'secondaryOutcomes': [{'measure': 'Peak oxygen consumption', 'timeFrame': '1-2 day before the intervention and 1-2days after the 4 week intervention peak oxygen is measured', 'description': 'Measurement of peak oxygen consumption during a ramp protocol on armergometer.'}, {'measure': 'Box and Block test', 'timeFrame': '1-2 day before the intervention and 1-2days after the 4 week intervention the box and block test is performed'}, {'measure': 'Sit to stand test', 'timeFrame': '1-2 day before the intervention and 1-2days after the 4 week intervention the sit to stand test is performed'}, {'measure': 'Handgrip test', 'timeFrame': '1-2 day before the intervention and 1-2days after the 4 week intervention the handgrip test is performed'}, {'measure': 'Wheel-chair test', 'timeFrame': '1-2 day before the intervention and 1-2days after the 4 week intervention the wheel-chair test is performed'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Exercise therapy', 'Aerobic training', 'Endurance training'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '24057428', 'type': 'DERIVED', 'citation': 'Skjerbaek AG, Naesby M, Lutzen K, Moller AB, Jensen E, Lamers I, Stenager E, Dalgas U. Endurance training is feasible in severely disabled patients with progressive multiple sclerosis. Mult Scler. 2014 Apr;20(5):627-30. doi: 10.1177/1352458513505351. Epub 2013 Sep 20.'}]}, 'descriptionModule': {'briefSummary': 'In the last decade physical exercise has become an accepted and integrated part of rehabilitation in patients with multiple sclerosis (MS). However, no studies have evaluated whether the most severely disabled patients can tolerate and benefit from exercise therapy. The purpose of this study is therefore to evaluate the feasibility of endurance training in severely disabled patients with MS.', 'detailedDescription': 'For many years, patients with multiple sclerosis (MS) have been advised not to participate in physical exercise. This advice was given in part because some patients were reported to experience symptom instability during exercise as a consequence of increased body temperature. A further argument was that avoiding exercise would preserve energy and thereby result in less fatigue, leaving more energy for activities of daily living. During the last decade, it has been more common to recommend exercise for MS patients, because of its recently proven beneficial effects in these patients.\n\nResistance- and endurance training constitutes the two extremes of basic physical exercise. To gain insight into the effects of exercise it therefore makes sense to understand the extremes. In mild to moderately impaired MS patients endurance training is well tolerated and providing beneficial effects. However, this exercise modality has not yet been tested in severely disabled patients, and it is therefore unclear if endurance training is feasible and beneficial in these patients. The investigators have, therefore, designed a feasibility study evaluating the effects of 4 weeks of endurance training in severely disabled MS patients (Expanded Disability Status Scale score \\> 6).\n\nPatients are inpatients at one of the national MS hospitals and endurance training is added to the usual care, and compared to usual care only (control group). Exercise frequency is 3 times per week, and intensity is controlled by HR measurements during exercise.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n\n -\\>18 years\n* Primary progressive or secondary progressive MS according to the McDonald criteria\n* 6.5 ≤ EDSS ≤ 8.0 and pyramidal score between 1 and 4\n* Maximal walking distance ≤ 10m\n\nExclusion Criteria:\n\n* Patients are excluded if they:\n* have dementia,alcoholism, or pacemaker treatment\n* any serious medical comorbidities\n* are pregnant\n* have done systematic endurance training (\\>1day/week) within the last 3 months.\n* complete less than 80% of the planned training sessions\n* medical conditions that exclude performance of a maximal endurance test.'}, 'identificationModule': {'nctId': 'NCT01752660', 'briefTitle': 'Exercise in Severely Disabled Patients With MS', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Endurance Training in Severely Disabled Patients With MS - a Feasibility Study', 'orgStudyIdInfo': {'id': 'UAarhus100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Endurance training', 'description': 'Standard care during a 4 week inpatient stay at a Danish multiple sclerosis rehabilitation center added 3 weekly sessions of endurance training for the upper extremity.', 'interventionNames': ['Behavioral: Endurance training', 'Behavioral: Standard care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard care', 'description': 'Standard care during a 4 week inpatient stay at a Danish multiple sclerosis rehabilitation center', 'interventionNames': ['Behavioral: Standard care']}], 'interventions': [{'name': 'Endurance training', 'type': 'BEHAVIORAL', 'description': 'Standard care during a 4 week inpatient stay at a Danish multiple sclerosis rehabilitation center added 3 weekly sessions of endurance training for the upper extremity.', 'armGroupLabels': ['Endurance training']}, {'name': 'Standard care', 'type': 'BEHAVIORAL', 'description': 'Standard care during a 4 week inpatient stay at a Danish multiple sclerosis rehabilitation center.', 'armGroupLabels': ['Endurance training', 'Standard care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8680', 'city': 'Ry', 'state': 'Jylland', 'country': 'Denmark', 'facility': 'MS Hospital in Ry', 'geoPoint': {'lat': 56.09038, 'lon': 9.76505}}], 'overallOfficials': [{'name': 'Ulrik Dalgas, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dep. Public Health, Aarhus University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Danish MS Society', 'class': 'UNKNOWN'}, {'name': 'Danish MS Hospitals, Haslev and Ry', 'class': 'OTHER'}, {'name': 'Aarhus University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}