Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-26 @ 1:04 AM
Study NCT ID:
NCT07291934
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilates and Resistance Training for Pain, Disability, and Sleep in Chronic Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}], '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': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2025-12-05', 'studyFirstSubmitQcDate': '2025-12-05', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity:', 'timeFrame': 'Assessment Time Points: Baseline (pre-intervention) Post-intervention (8 weeks) Follow-up (16 weeks)', 'description': 'Measured using the Visual Analog Scale (VAS), a 10-cm line where 0 indicates "no pain" and 10 indicates "worst imaginable pain." It captures the patient\'s perceived pain severity.'}, {'measure': 'Disability', 'timeFrame': 'Assessment Time Points: Baseline (pre-intervention) Post-intervention (8 weeks) Follow-up (16 weeks)', 'description': "Oswestry Disability Index (ODI)\n\nThe Oswestry Disability Index (ODI) is a widely used, validated questionnaire that assesses functional disability in individuals with low back pain. It measures the impact of back pain on a person's ability to perform activities of daily living (ADL) and overall functional limitations.\n\nStructure:\n\nThe ODI contains 10 sections, each focusing on a different aspect of daily function:\n\nPain intensity\n\nPersonal care (washing, dressing)\n\nLifting\n\nWalking\n\nSitting\n\nStanding\n\nSleeping\n\nSocial life\n\nTraveling\n\nEmployment/homemaking\n\nEach section has 6 statements scored from 0 to 5, with higher scores indicating greater disability."}, {'measure': 'Sleep_ Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'Assessment Time Points: Baseline (pre-intervention) Post-intervention (8 weeks) Follow-up (16 weeks)', 'description': "The Pittsburgh Sleep Quality Index (PSQI) is a validated, self-reported questionnaire used to assess sleep quality and disturbances over the past month. It is widely used in clinical and research settings, including studies on chronic pain and musculoskeletal disorders.\n\nStructure:\n\nThe PSQI consists of 19 individual items combined into 7 components:\n\nSubjective sleep quality - the individual's perception of their sleep\n\nSleep latency - time taken to fall asleep\n\nSleep duration - total hours of sleep per night\n\nHabitual sleep efficiency - percentage of time in bed actually spent sleeping\n\nSleep disturbances - factors causing sleep interruptions (e.g., waking up, pain, environmental disturbances)\n\nUse of sleep medication - frequency of taking sleep aids\n\nDaytime dysfunction - difficulty staying awake or maintaining function during the day\n\nScoring:\n\nEach component is scored from 0 (no difficulty) to 3 (severe difficulty).\n\nThe component scores are summed to generate a global PSQI score"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sleep', 'chronic low back pain', 'disability', 'Pilate', 'Resistance traning'], 'conditions': ['Chronic Low Back Pain']}, 'descriptionModule': {'briefSummary': 'This study will investigate the effect of Pilates and resistance training on pain, disability, and sleep quality in patients with chronic low back pain and sleep disturbances. Participants will be randomly assigned into three groups:\n\nCombined intervention group: Pilates plus resistance training\n\nSingle intervention group: Pilates alone\n\nControl group: Advices only\n\nAll interventions will be delivered 3 times per week for 8 weeks, with outcome measures assessed at baseline, post-intervention (8 weeks), and follow-up (16 weeks). It is expected that the combined intervention group will show the greatest improvements in pain, disability, and sleep quality, while the single intervention group will demonstrate moderate benefits compared with usual care.', 'detailedDescription': 'This study will investigate the effects of Pilates and resistance training on pain, disability, and sleep quality in patients with chronic low back pain and sleep disturbances in the Gaza Strip. The study will use a 3-arm randomized controlled trial design, with participants randomly assigned to one of three groups:\n\nCombined Intervention Group: Pilates plus resistance training\n\nSingle Intervention Group: Pilates or resistance training alone\n\nControl Group: Usual care\n\nThe intervention groups will participate in 2 supervised sessions per week for 8 weeks. The control group will continue their usual care without structured or supervisedexercise.\n\nOutcome measures will be assessed at baseline, post-intervention (8 weeks), and follow-up (16 weeks). The outcomes include pain intensity and disability, while sleep quality.\n\nThe study aims to determine whether the combined exercise intervention produces greater improvements than a single exercise intervention or usual care, providing evidence for the most effective rehabilitation strategy for patients with chronic low back pain and sleep disturbances.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinically diagnosed with chronic low back pain (CLBP), defined as pain localized between the lower rib margin and gluteal folds, lasting ≥12 weeks.\n* Sleep Quality: Poor sleep quality, defined as PSQI global score \\>5.\n\nExclusion Criteria:\n\n* Specific LBP causes: Low back pain due to fractures, tumors, infections, inflammatory disorders, or systemic disease.\n* Recent spinal surgery: History of lumbar spine surgery within the past 12 months.\n* Severe comorbidities: Serious cardiovascular, respiratory, neurological, or musculoskeletal disorders that contraindicate exercise.\n* Pregnancy or planned pregnancy during the study period.\n* Current participation in structured exercise programs targeting the back (Pilates, resistance training, or core stabilization) within the last 3 months.\n* Use of sleep medications or interventions that cannot be maintained stable during the study period.'}, 'identificationModule': {'nctId': 'NCT07291934', 'briefTitle': 'Pilates and Resistance Training for Pain, Disability, and Sleep in Chronic Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Effect of Pilates and Resistance Training on Pain, Disability, and Sleep Quality in Patients With Chronic Low Back Pain and Sleep Disturbances', 'orgStudyIdInfo': {'id': 'ALAZHAR UNIVERSITY in Gaza'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Combined Intervention Group (Pilates + Resistance Training):', 'description': 'Participants in this group will receive both Pilates and resistance training exercises. The program will be supervised 2 times per week for 8 weeks.This arm is designed to evaluate the synergistic effect of the combined interventions on pain, disability, and sleep quality.', 'interventionNames': ['Other: Combined Intervention (Pilates + Resistance Training)']}, {'type': 'EXPERIMENTAL', 'label': 'Pilates Group', 'description': 'Participants will perform Pilates exercises only under supervision 2 times per week for 8 weeks, with optional home practice. This arm will assess the effectiveness of Pilates alone on the study outcomes.', 'interventionNames': ['Other: Pilates']}, {'type': 'OTHER', 'label': 'Control Group (Usual Care):', 'description': 'Participants in the control group will continue their routine care without structured or supervised exercise. This group will serve as a baseline comparison to determine the effects of the interventions beyond standard care.', 'interventionNames': ['Other: Control (Usual Care)']}], 'interventions': [{'name': 'Combined Intervention (Pilates + Resistance Training)', 'type': 'OTHER', 'description': 'Participants will receive both Pilates and resistance training exercises, supervised 2 times per week for 8 weeks. This intervention aims to evaluate the combined effect on improving pain, disability, and sleep quality.', 'armGroupLabels': ['Combined Intervention Group (Pilates + Resistance Training):']}, {'name': 'Pilates', 'type': 'OTHER', 'description': 'Participants will perform Pilates exercises only, supervised 2 times per week for 8 weeks. This intervention will assess the effectiveness of Pilates alone on the study outcomes.', 'armGroupLabels': ['Pilates Group']}, {'name': 'Control (Usual Care)', 'type': 'OTHER', 'description': 'Participants will continue their routine care without structured exercise. This intervention serves as a baseline comparison to determine the effects of the exercise programs beyond standard care.', 'armGroupLabels': ['Control Group (Usual Care):']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mosab M Aldabbas, PhD', 'role': 'CONTACT', 'email': 'mosab.m.aldabbas@gmail.com', 'phone': '00972597451222'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'ASSISTANT PROFESSOR AT AL AZHAR UNIVERSITY', 'investigatorFullName': 'Mosab ALdabbas', 'investigatorAffiliation': 'Al-Azhar University'}}}}