Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2026-03-06 @ 4:46 PM
Study NCT ID:
NCT02422693
Status:
COMPLETED
Last Update Posted:
2017-07-11
First Post:
2015-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aquatic Exercises for Patients With Chronic Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-05', 'studyFirstSubmitDate': '2015-04-06', 'studyFirstSubmitQcDate': '2015-04-20', 'lastUpdatePostDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Roland-Morris Questionnaire', 'timeFrame': 'baseline and 9 weeks', 'description': 'Functionality'}], 'secondaryOutcomes': [{'measure': 'Change in Pain status', 'timeFrame': 'baseline and 9 weeks', 'description': 'Pain'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hydrotherapy', 'aquatic'], 'conditions': ['Chronic Low Back Pain']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to compare the effect of aquatic exercises (AEG) to the aquatic exercises plus aerobic training (deep-water running) (AEDWRG) on functional status and pain in patients with specific chronic low back pain.', 'detailedDescription': 'In general, the population will have at least one episode of low back pain during their lifetime, with recurrence in most cases. Several treatments have been proposed for these patients and the evidence is still not clear about the effectiveness of aquatic exercises when compared to other modalities of exercises in the water. This study will be a randomized controlled trial following the Consort-Statement principles. The subjects, aged between 20 and 50 years, after signing the informed consent will be randomly allocated to one group treatment: aquatic exercises (AEG) or aquatic exercises associated to deep-water running (AEDWRG). The duration of the protocol will be set at 12 weeks, 3x-week.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Exclusive diagnosis of chronic low back pain (more than 12 weeks)\n\nExclusion Criteria:\n\n* Central nervous system disease\n* Pregnant\n* Fear of water'}, 'identificationModule': {'nctId': 'NCT02422693', 'briefTitle': 'Aquatic Exercises for Patients With Chronic Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Estadual de Londrina'}, 'officialTitle': 'Aquatic Exercises Versus Aquatic Exercises Associated to Deep Water-running for Patients With Chronic Low Back Pain: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '# 04/2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aquatic exercises', 'description': 'Warm-up, lumbar mobilization, stretching and relaxation. 3x-week (9 weeks), indoor pool, 32o.C/89.6o.F.', 'interventionNames': ['Other: Aquatic Exercises']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aquatic exercises + Deep-water running', 'description': 'Same as AEG with addition of 20 minutes of running without touch the ground, 3x-week (9 weeks), indoor pool, 30o.C/86o.F.', 'interventionNames': ['Other: Aquatic Exercises', 'Other: Deep-water running']}], 'interventions': [{'name': 'Aquatic Exercises', 'type': 'OTHER', 'otherNames': ['Aquatic Physical Therapy'], 'description': 'Exercises performed in the water.', 'armGroupLabels': ['Aquatic exercises', 'Aquatic exercises + Deep-water running']}, {'name': 'Deep-water running', 'type': 'OTHER', 'description': 'It is a non-impact form of running executed in place in (higher than 2 meters) the water wearing a flotation belt. Heart rate is controlled by heart rate watch', 'armGroupLabels': ['Aquatic exercises + Deep-water running']}]}, 'contactsLocationsModule': {'locations': [{'zip': '86038440', 'city': 'Londrina', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Aquatic Physical Therapy Center "Paulo A. Seibert"', 'geoPoint': {'lat': -23.31028, 'lon': -51.16278}}], 'overallOfficials': [{'name': 'Jefferson R Cardoso, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade Estadual de Londrina'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Estadual de Londrina', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Brazil', 'class': 'OTHER_GOV'}, {'name': 'Fundação Araucária', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PT, PhD', 'investigatorFullName': 'Jefferson Rosa Cardoso', 'investigatorAffiliation': 'Universidade Estadual de Londrina'}}}}