Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:56 PM
Study NCT ID:
NCT06921694
Status:
RECRUITING
Last Update Posted:
2025-12-12
First Post:
2025-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Combined Exercise Programme Involving Strengthening, Flexibility and Aerobic Exercise for Lower Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'It is not possible to blind/mask the investigators or participants due to the nature of the intervention (i.e. they know what exercise they are doing). However a different person undertakes the randomisation to keep that separate.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2025-03-26', 'studyFirstSubmitQcDate': '2025-04-03', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS pain score', 'timeFrame': 'Baseline, 8 weeks, 12 months', 'description': 'VAS pain score on 100 point scale\n\n* Range: 0 to 100\n* Anchors: 0 = no pain, 100 = worst imaginable pain\n* Interpretation: Higher scores indicate worse pain'}], 'secondaryOutcomes': [{'measure': 'Oswestry disability index', 'timeFrame': 'Baseline, 8 weeks, 12 months', 'description': 'Oswestry disability index (PROM questionnaire)\n\n* Range: 0 to 100 (expressed as a percentage)\n* Anchors: 0 = no disability, 100 = maximum disability\n* Interpretation: Higher scores indicate greater disability'}, {'measure': 'Roland Morris Disability questionnaire', 'timeFrame': 'Baseline, 8 weeks, 12 months', 'description': 'Roland Morris Disability questionnaire (PROM questionnaire)\n\n* Range: 0 to 24 (some versions extend to 0-23 or 0-25 depending on adaptation, but 0-24 is most common)\n* Anchors: 0 = no disability, 24 = maximum disability\n* Interpretation: Higher scores indicate greater disability'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic non specific low back pain', 'exercise intervention'], 'conditions': ['Low Back Pain, Chronic']}, 'descriptionModule': {'briefSummary': 'This randomised controlled trial will evaluate the effectiveness of different exercise modalities for individuals with low back pain. Participants will be allocated to one of three groups: a control arm (usual exercise), a running-based intervention, or a swimming/cycling-based intervention. Outcomes related to pain and function will be measured at baseline, 8 weeks, and 12 months.', 'detailedDescription': 'This study is designed to assess the impact of structured exercise interventions on pain and functional outcomes in otherwise healthy adults with low back pain. Eligible participants recruited from the community will be randomised into one of three arms: (1) control group, continuing their usual exercise activities; (2) running intervention group; or (3) swimming/cycling intervention group.\n\nThe two intervention arms will complete an 8-week combined exercise programme consisting of aerobic training (running or swimming/cycling, depending on group assignment), progressive resistance training, and prescribed flexibility exercises. The programme is structured to gradually increase in intensity over the 8-week period to enhance adherence and minimize risk of injury.\n\nEfficacy will be evaluated using validated patient-reported outcome measures (PROMs) capturing pain intensity and functional capacity. These assessments will be administered at three time points: baseline (prior to the intervention), post-intervention (8 weeks), and long-term follow-up (12 months). This design will enable analysis of both the short-term and sustained effects of exercise modality on low back pain management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-45 years\n* Participant is willing and able to give informed consent for participation in the study\n* Suffering from chronic NSLBP (more than 3 months, localised below the costal margin and above the gluteal folds)\n* Suffers from pain or functional limitations as a result of their LBP (minimum VAS (back) score of 3/10 or ODI score of at least 5/50 or RMD score of at least 5/24 (note, unlike ODI, RMD does not describe specific cuts offs for different levels of disability)\n* Able to exercise\n\nExclusion Criteria:\n\n* Radiating pain to leg / sciatica / acute radiculopathy\n* Specific diagnosis/condition for LBP (e.g. herniated disk, degenerative disk disease, spondylolysis, spinal stenosis, spinal tumour, facet joint damage)\n* History of osteoporosis , arthritis, scoliosis, or kyphosis.\n* Current spinal infection, cancer or a current fracture (any bone).\n* History of spinal/back surgery\n* Unable to participate in physical activity and exercise\n* Pregnant or breast feeding\n* History of substance abuse\n* History of psychiatric illness (eg. depression, dementia, schizophrenia) for which currently taking medication\n* History or current neurological condition (e.g. epilepsy)\n* Not in possession or have access to adapted equipment (phone, computer, functioning WIFI)\n* Unable to understand and communicate in English\n* Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance'}, 'identificationModule': {'nctId': 'NCT06921694', 'briefTitle': 'A Combined Exercise Programme Involving Strengthening, Flexibility and Aerobic Exercise for Lower Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Nottingham'}, 'officialTitle': 'A Combined Exercise Programme Involving Strengthening, Flexibility and Aerobic Exercise for Lower Back Pain: a Randomised-controlled Study', 'orgStudyIdInfo': {'id': 'FMHS 279 0423'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Participants continue with their usual exercise regime.'}, {'type': 'EXPERIMENTAL', 'label': 'Runner Group', 'description': 'Particpants follow an 8 week intervention including aerobic elements (running), a schedule of gradually intensitfing strengthening exercises and flexibility exercises.', 'interventionNames': ['Behavioral: Runner group']}, {'type': 'EXPERIMENTAL', 'label': 'Swim/Cycle group', 'description': 'Particpants follow an 8 week intervention including aerobic elements (swim/cycle), a schedule of gradually intensitfing strengthening exercises and flexibility exercises.', 'interventionNames': ['Behavioral: Swim/Cycle Group']}], 'interventions': [{'name': 'Runner group', 'type': 'BEHAVIORAL', 'description': 'The intervention groups undertake 8 weeks of a combined exercise programme including aerobic elements (running), a schedule of gradually intensifying strengthening exercises and flexibility exercises', 'armGroupLabels': ['Runner Group']}, {'name': 'Swim/Cycle Group', 'type': 'BEHAVIORAL', 'description': 'The intervention groups undertake 8 weeks of a combined exercise programme including aerobic elements (swim/cycle), a schedule of gradually intensitfing strengthening exercises and flexibility exercises', 'armGroupLabels': ['Swim/Cycle group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NG7 2UH', 'city': 'Nottingham', 'state': 'Notts', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Professor Sport Exercise and Nutrition Education', 'role': 'CONTACT', 'email': 'kimberley.edwards@nottingham.ac.uk', 'phone': '+44 1157486500'}], 'facility': "University of Nottingham, Queen's Medical Centre", 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'Kimberley Edwards', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nottingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'This is a small study with limited administrative support.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nottingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Sport Exercise and Nutrition Education', 'investigatorFullName': 'Kimberley Edwards', 'investigatorAffiliation': 'University of Nottingham'}}}}